The SAMPLE PREPARATION AND BIOANALYSIS VALIDATION FOR NATURAL PRODUCT SAMPLE

  • Ida Ayumiati Padjadjaran University

Abstract

ABSTRACT


The pharmaceutical study bioanalysis parameters and their validation are important for their application in natural drug discovery and preparation for natural medicine products with safe drug development approaches. Bioanalysis data for natural products can provide quantitative information on active compounds from natural products for the purposes of pharmacokinetics, pharmacodynamics, bioavailability, bioequivalence and toxicokinetics. Bioanalysis validation provides useful guidance for obtaining accurate data on drug discovery, preclinical & clinical testing of natural drug product development and to ensure the methods used are suitable for application in testing these samples. In general, sample preparation and validation of the bioanalysis method are part of the pharmacokinetic characterization of a chemical compound from the discovery to the development stage of natural material products. Therefore, this paper aims to discuss how to prepare samples and validate bioanalysis for natural products.

Keywords: Bioanalysis, Drugs, Natural Product, Validation

References

REFERENCES
[1] Abdelhameed, A. S., & Afifi, S. A. (2014). A Validated HPLC-DAD Method for Simultaneous Determination of Etodolac and Pantoprazole in Rat Plasma. Journal of Chemistry, 2014. https://doi.org/10.1155/2014/719801
[2] Agency, E. M. (2011). Guideline on bioanalytical method validation.
[3] Alshishani, A., Makahleh, A., Yap, H. F., Gubartallah, E. A., Salhimi, S. M., & Saad, B. (2016). Ion-pair vortex assisted liquid-liquid microextraction with back extraction coupled with high performance liquid chromatography-UV for the determination of metformin in plasma. Talanta, 161, 398–404. https://doi.org/10.1016/j.talanta.2016.08.067
[4] Amini, H., Ahmadiani, A., & Gazerani, P. (2005). Determination of metformin in human plasma by high-performance liquid chromatography. Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences, 824(1–2), 319–322. https://doi.org/10.1016/j.jchromb.2005.07.009
[5] Bioanalytical strategy in drug discovery. (n.d.).
[6] Cao, F. R., Xiao, B. X., Wang, L. S., Tao, X., Yan, M. Z., Pan, R. Le, … Chang, Q. (2017). Plasma and brain pharmacokinetics of ganoderic acid A in rats determined by a developed UFLC–MS/MS method. Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences, 1052, 19–26. https://doi.org/10.1016/j.jchromb.2017.03.009
[7] Carbonaro, M., Grant, G., & Pusztai, A. (2001). Evaluation of polyphenol bioavailability in rat small intestine. European Journal of Nutrition, 40(2), 84–90. https://doi.org/10.1007/s003940170020
[8] Chen, W. D., Liang, Y., Zhang, H., Li, H., Xiong, Y., Wang, G. J., & Xie, L. (2006). Simple, sensitive and rapid LC-MS method for the quantitation of indapamide in human plasma-application to pharmacokinetic studies. Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences, 842(1), 58–63. https://doi.org/10.1016/j.jchromb.2006.03.024
[9] Cheng, C. R., Yang, M., Guan, S. H., Wu, X. H., Pang, X. Y., Wang, Y., … Guo, D. A. (2013). Pharmacokinetics of ganoderic acid D and its main metabolite by liquid chromatography-tandem mass spectrometry. Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences, 930, 1–6. https://doi.org/10.1016/j.jchromb.2013.04.015
[10] Dai, R., Gao, J., & Bi, K. (2004). High-Performance Liquid Chromatographic Method for the Determination and Pharmacokinetic Study of Mangiferin in Plasma of Rats Having Taken the Traditional Chinese Medicinal Preparation Zi-Shen Pill. Journal of Chromatographic Science, 42(2), 88–90. https://doi.org/10.1093/chromsci/42.2.88
[11] Departemen Kesehatan Republik Indonesia-Direktorat Pengawasan Obat Tradisional. (2000). Parameter standar umum ekstrak tumbuhan obat.
[12] DI., D. W. dan E. (2005). Metabolomics: Current analytical platforms and methodologies. Trends in Analytical Chemistry.
[13] Diao, X., Ma, Z., Wang, H., Zhong, D., Zhang, Y., Jin, J., … Chen, X. (2013). Simultaneous quantitation of 3-n-butylphthalide (NBP) and its four major metabolites in human plasma by LC-MS/MS using deuterated internal standards. Journal of Pharmaceutical and Biomedical Analysis, 78–79, 19–26. https://doi.org/10.1016/j.jpba.2013.01.033
[14] Ding, L., Zhu, T., Song, Q., Zhang, Y., & Shen, J. (2007). HPLC-APCI-MS for the determination of teprenone in human plasma: Method and clinical application. Journal of Pharmaceutical and Biomedical Analysis, 44(3 SPEC. ISS.), 779–785. https://doi.org/10.1016/j.jpba.2007.03.021
[15] Dong, Y. yao, Mao, B., Guan, H., Bai, Y., Chi, B., Shan, Y. yuan, … Ge, R. shan. (2015). Determination of songorine in rat plasma by UPLC-MS/MS: Assay development and application to pharmacokinetic study. Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences, 1002, 234–238. https://doi.org/10.1016/j.jchromb.2015.08.037
[16] Fachi, M. M., Cerqueira, L. B., Leonart, L. P., De Francisco, T. M. G., & Pontarolo, R. (2016). Simultaneous quantification of antidiabetic agents in human plasma by a UPLC-QToF-MS method. PLoS ONE, 11(12), 1–17. https://doi.org/10.1371/journal.pone.0167107
[17] Fan, L. hua, Li, X., Chen, D. yuan, Zhang, N., Wang, Y., Shan, Y., … Ge, R. S. (2015). Determination of acacetin in rat plasma by UPLC-MS/MS and its application to a pharmacokinetic study. Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences, 986–987, 18–22. https://doi.org/10.1016/j.jchromb.2015.01.040
[18] FDA, U. S. (2013). Guidance for Industry, Bioanalytical Method Validations; U.S. Department of Health and Human Services, Food and Drug Administration Center for Drug Evaluation and Research (CDER).
[19] Felgines, C., Talavéra, S., Gonthier, M.-P., Texier, O., Scalbert, A., Lamaison, J.-L., & Rémésy, C. (2003). Strawberry Anthocyanins Are Recovered in Urine as Glucuro- and Sulfoconjugates in Humans. The Journal of Nutrition, 133(5), 1296–1301. https://doi.org/10.1093/jn/133.5.1296
[20] Gao, J., Zhong, D., Duan, X., & Chen, X. (2007). Liquid chromatography/negative ion electrospray tandem mass spectrometry method for the quantification of rosuvastatin in human plasma: Application to a pharmacokinetic study. Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences, 856(1–2), 35–40. https://doi.org/10.1016/j.jchromb.2007.05.012
[21] Geng, P., Luo, J., Weng, Z., Fan, Z., Zhang, B., Ma, J., … Zhang, M. (2018). Determination of armepavine in mouse blood by UPLC-MS/MS and its application to pharmacokinetic study. Biomedical Chromatography, 32(9). https://doi.org/10.1002/bmc.4273
[22] Gu, S., Zhu, G., Wang, Y., Li, Q., Wu, X., Zhang, J., … Li, X. (2014). A sensitive liquid chromatography-tandem mass spectrometry method for pharmacokinetics and tissue distribution of nuciferine in rats. Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences, 961, 20–28. https://doi.org/10.1016/j.jchromb.2014.04.038
[23] Han, D., Chen, C., Zhang, C., Zhang, Y., & Tang, X. (2010). Determination of mangiferin in rat plasma by liquid-liquid extraction with UPLC-MS/MS. Journal of Pharmaceutical and Biomedical Analysis, 51(1), 260–263. https://doi.org/10.1016/j.jpba.2009.07.021
[24] HJ, E. T. and G. (2012). Quality Control for Medicinal Plants. Medicinal and Aromatic Plants.
[25] Hou, S., Wang, F., Li, Y., Li, Y., Wang, M., Sun, D., & Sun, C. (2012). Pharmacokinetic study of mangiferin in human plasma after oral administration. Food Chemistry, 132(1), 289–294. https://doi.org/10.1016/j.foodchem.2011.10.079
[26] Hua, X., Liang, C., Dong, L., Qu, X., & Zhao, T. (2015). Simultaneous determination and pharmacokinetic study of gambogic acid and gambogenic acid in rat plasma after oral administration of Garcinia hanburyi extracts by LC-MS/MS. Biomedical Chromatography, 29(4), 545–551. https://doi.org/10.1002/bmc.3311
[27] Huang, J. T., Cheng, Y. Y., Lin, L. C., & Tsai, T. H. (2017). Structural Pharmacokinetics of Polymethoxylated Flavones in Rat Plasma Using HPLC-MS/MS. Journal of Agricultural and Food Chemistry, 65(11), 2406–2413. https://doi.org/10.1021/acs.jafc.6b05390
[28] Huang, L., Olson, A., Gingrich, D., & Aweeka, F. T. (2013). Determination of artemether and dihydroartemisinin in human plasma with a new hydrogen peroxide stabilization method. Bioanalysis, 5(12), 1501–1506. https://doi.org/10.4155/bio.13.91
[29] Huang, Y., Sun, H. Y., Qin, X. L., Li, Y. J., Liao, S. G., Gong, Z. P., … Zheng, L. (2017). A UPLC-MS/MS method for simultaneous determination of free and total forms of a phenolic acid and two flavonoids in rat plasma and its application to comparative pharmacokinetic studies of Polygonum capitatum extract in rats. Molecules, 22(3). https://doi.org/10.3390/molecules22030353
[30] Indonesia, D. K. R. (1985). Obat kelompok fitoterapi. Rencana kerangka tahap-tahap pengembangan obat tradisional.
[31] Iqbal, M., Ezzeldin, E., Al-Rashood, K. A., Al-Shdefat, R., & Anwer, M. K. (2018). High throughput ?-SPE based elution coupled with UPLC–MS/MS for determination of eluxadoline in plasma sample: Application in pharmacokinetic characterization of PLGA nanoparticle formulations in rats. Journal of Pharmaceutical and Biomedical Analysis, 149, 172–178. https://doi.org/10.1016/j.jpba.2017.10.024
[32] Ji, P. Y., Li, Z. W., Yang, Q., & Wu, R. (2015). Rapid determination of ruscogenin in rat plasma with application to pharmacokinetic study. Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences, 985, 71–74. https://doi.org/10.1016/j.jchromb.2015.01.022
[33] Jiamboonsri, P., Pithayanukul, P., Bavovada, R., Gao, S., & Hu, M. (2015). A validated liquid chromatography-tandem mass spectrometry method for the determination of methyl gallate and pentagalloyl glucopyranose: Application to pharmacokinetic studies. Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences, 986–987, 12–17. https://doi.org/10.1016/j.jchromb.2015.02.006
[34] Jiang, L., Xiong, Y., Yu, L., Chen, Y., Zhang, Q., Ding, X., … Xu, G. (2019). Simultaneous determination of seven active components in rat plasma by UHPLC-MS/MS and application to a quantitative study after oral administration of huang-lian jie-du decoction in high fat-induced atherosclerosis rats. International Journal of Analytical Chemistry, 2019. https://doi.org/10.1155/2019/5628160
[35] Kaneko, R., Hattori, S., Furuta, S., Hamajima, M., Hirata, Y., Watanabe, K., … Ishii, A. (2006). Sensitive analysis of aconitine, hypaconitine, mesaconitine and jesaconitine in human body fluids and Aconitum tubers by LC/ESI-TOF-MS. Journal of Mass Spectrometry, 41(6), 810–814. https://doi.org/10.1002/jms.1038
[36] Kanellos, P. T., Kaliora, A. C., Gioxari, A., Christopoulou, G. O., Kalogeropoulos, N., & Karathanos, V. T. (2013). Absorption and Bioavailability of Antioxidant Phytochemicals and Increase of Serum Oxidation Resistance in Healthy Subjects Following Supplementation with Raisins. Plant Foods for Human Nutrition, 68(4), 411–415. https://doi.org/10.1007/s11130-013-0389-2
[37] Karnes HT, Shiu G, S. V. (1991). Validation of bioanalytical methods.
[38] Kondo, M., Zhang, L., Ji, H., Kou, Y., & Ou, B. (2009). Bioavailability and antioxidant effects of a xanthone-rich mangosteen (Garcinia mangostana) product in humans. Journal of Agricultural and Food Chemistry, 57(19), 8788–8792. https://doi.org/10.1021/jf901012f
[39] Koseki, N., Kawashita, H., Niina, M., Nagae, Y., & Masuda, N. (2005). Development and validation for high selective quantitative determination of metformin in human plasma by cation exchanging with normal-phase LC/MS/MS. Journal of Pharmaceutical and Biomedical Analysis, 36(5), 1063–1072. https://doi.org/10.1016/j.jpba.2004.09.007
[40] Lang JR, B. S. (1991). A comprehensive method validation strategy for bioanalytical applications in the pharmaceutical industry--1. Experimental considerations.
[41] Li, L., Shaik, A. A., Zhang, J., Nhkata, K., Wang, L., Zhang, Y., … Lü, J. (2011). Preparation of penta-O-galloyl-?-d-glucose from tannic acid and plasma pharmacokinetic analyses by liquid-liquid extraction and reverse-phase HPLC. Journal of Pharmaceutical and Biomedical Analysis, 54(3), 545–550. https://doi.org/10.1016/j.jpba.2010.09.028
[42] Li, T., Yan, Z., Zhou, C., Sun, J., Jiang, C., & Yang, X. (2013). Simultaneous quantification of paeoniflorin, nobiletin, tangeretin, liquiritigenin, isoliquiritigenin, liquiritin and formononetin from Si-Ni-San extract in rat plasma and tissues by liquid chromatography-tandem mass spectrometry. Biomedical Chromatography, 27(8), 1041–1053. https://doi.org/10.1002/bmc.2904
[43] Liachenko, N., Boulamery, A., & Simon, N. (2015). Nicotine and metabolites determination in human plasma by ultra performance liquid chromatography-tandem mass spectrometry: A simple approach for solving contamination problem and clinical application. Fundamental and Clinical Pharmacology, 29(5), 499–509. https://doi.org/10.1111/fcp.12132
[44] Liang, Y., Liu, L., Lu, S., Xie, L., Kang, A., Xie, T., … Wang, G. ji. (2009). Application of a hybrid ion trap/time-of-flight mass spectrometer in metabolite characterization studies: Structural identification of the metabolism profile of antofloxacin in rats rapidly using MSn information and accurate mass measurements. Journal of Pharmaceutical and Biomedical Analysis, 50(5), 1022–1025. https://doi.org/10.1016/j.jpba.2009.05.008
[45] Liu, X. wei, Yang, J. ling, Niu, W., Jia, W. wei, Olaleye, O. E., Wen, Q., … Li, C. (2018). Human pharmacokinetics of ginkgo terpene lactones and impact of carboxylation in blood on their platelet-activating factor antagonistic activity. Acta Pharmacologica Sinica, 39(12), 1935–1946. https://doi.org/10.1038/s41401-018-0086-7
[46] Liu, Z., Yu, W., Zhang, H., Gu, F., & Jin, X. (2016). Salting-out homogenous extraction followed by ionic liquid/ionic liquid liquid–liquid micro-extraction for determination of sulfonamides in blood by high performance liquid chromatography. Talanta, 161(June), 748–754. https://doi.org/10.1016/j.talanta.2016.09.006
[47] Lou, Y., Hu, H., Liu, Y., Yu, Q., Li, L., Ping, L., … Zeng, S. (2011). Determination of chamaechromone in rat plasma by liquid chromatography-tandem mass spectrometry: Application to pharmacokinetic study. Journal of Pharmaceutical and Biomedical Analysis, 55(5), 1163–1169. https://doi.org/10.1016/j.jpba.2011.04.009
[48] Lu, Y., Li, P., Liu, H., Du, S., Cheng, Y., Wu, H., … Shao, B. (2015). Simultaneous determination of flavonols and terpene lactones in beagle dog plasma by ultra-performance liquid chromatography-tandem - mass spectrometry: 2. Application to pharmacokinetic studies on ginkgo leaf extract. Tropical Journal of Pharmaceutical Research, 14(5), 879–889. https://doi.org/10.4314/tjpr.v14i5.19
[49] Lv, S. feng, Wang, X. hong, Li, H. wei, Zhang, X. lei, & Wang, B. (2015). Quantification of liensinine in rat plasma using ultra-performance liquid chromatography tandem mass spectrometry and its application to a pharmacokinetic study. Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences, 992, 43–46. https://doi.org/10.1016/j.jchromb.2015.04.023
[50] Margalef, M., Pons, Z., Muguerza, B., & Arola-Arnal, A. (2014). A rapid method to determine colonic microbial metabolites derived from grape flavanols in rat plasma by liquid chromatography-tandem mass spectrometry. Journal of Agricultural and Food Chemistry, 62(31), 7698–7706. https://doi.org/10.1021/jf5019752
[51] Matysik, S., & Schmitz, G. (2015). Determination of steroid hormones in human plasma by GC-triple quadrupole MS. Steroids, 99(PB), 151–154. https://doi.org/10.1016/j.steroids.2015.01.016
[52] Montesano, C., Vannutelli, G., Piccirilli, V., Sergi, M., Compagnone, D., & Curini, R. (2017). Application of a rapid ?-SPE clean-up for multiclass quantitative analysis of sixteen new psychoactive substances in whole blood by LC–MS/MS. Talanta, 167, 260–267. https://doi.org/10.1016/j.talanta.2017.02.019
[53] Müller-Sepúlveda, A., Letelier, M. E., San Martin, B., & Saavedra-Saavedra, I. (2016). Simultaneous determination of different flavonoids in human plasma by a simple HPLC assay. Journal of the Chilean Chemical Society, 61(4), 3164–3169. https://doi.org/10.4067/S0717-97072016000400003
[54] Murkovic, M., Toplak, H., Adam, U., & Pfannhauser, W. (2000). Analysis of anthocyanins in plasma for determination of their bioavailability. Journal of Food Composition and Analysis, 13(4), 291–296. https://doi.org/10.1006/jfca.1999.0852
[55] Nakamura, Y., Tsuji, S., & Tonogai, Y. (2003). Method for analysis of tannic acid and its metabolites in biological samples: Application to tannic acid metabolism in the rat. Journal of Agricultural and Food Chemistry, 51(1), 331–339. https://doi.org/10.1021/jf020847+
[56] Nielsen, S. E., Freese, R., Cornett, C., & Dragsted, L. O. (2000). Identification and quantification of flavonoids in human urine samples by column-switching liquid chromatography coupled to atmospheric pressure chemical ionization mass spectrometry. Analytical Chemistry, 72(7), 1503–1509. https://doi.org/10.1021/ac991296y
[57] OuYang, X. K., Cai, M. Q., Chen, X. H., & Jin, M. C. (2008). Development and validation of a liquid chromatography coupled with atmospheric-pressure chemical ionization ion trap mass spectrometric method for the simultaneous determination of triptolide, tripdiolide, and tripterine in human serum. Journal of Analytical Toxicology, 32(9), 737–743. https://doi.org/10.1093/jat/32.9.737
[58] P.Laxman Kole, G. Venkatesh, J. K. and R. S. (2011). Recent advances is ?sample preparation techniques for effective bioanalytical methods. Biomedical Chromatography.
[59] Paganga, G., & Rice-Evans, C. A. (1997). The identification of flavonoids as glycosides in human plasma. FEBS Letters, 401(1), 78–82. https://doi.org/10.1016/S0014-5793(96)01442-1
[60] Pandey S, Pandey P, T. R. (2010). Bioanalysis in drug discovery and development. Pharm Methods.
[61] Papada, E., Gioxari, A., Brieudes, V., Amerikanou, C., Halabalaki, M., Skaltsounis, A. L., … Kaliora, A. C. (2018). Bioavailability of Terpenes and Postprandial Effect on Human Antioxidant Potential. An Open-Label Study in Healthy Subjects. Molecular Nutrition and Food Research, 62(3), 1–9. https://doi.org/10.1002/mnfr.201700751
[62] Papada, E., Torovi?, L., Amerikanou, C., Kalogeropoulos, N., Smyrnioudis, I., & Kaliora, A. C. (2018). Modulation of free amino acid profile in healthy humans administered with mastiha terpenes. An open-label trial. Nutrients, 10(6). https://doi.org/10.3390/nu10060715
[63] Petiwala, S. M., Li, G., Ramaiya, A., Kumar, A., Gill, R. K., Saksena, S., & Johnson, J. J. (2014). Pharmacokinetic characterization of mangosteen (Garcinia mangostana) fruit extract standardized to ?-mangostin in C57BL/6 mice. Nutrition Research, 34(4), 336–345. https://doi.org/10.1016/j.nutres.2014.03.002
[64] Peys, E., Vandenkerckhove, J., Van Hemel, J., & Sas, B. (2005). Simultaneous determination of ?-artemether and its metabolite dihydroartemisinin in human plasma and urine by a high-performance liquid chromatography-mass spectrometry assay using electrospray ionisation. Chromatographia, 61(11–12), 637–641. https://doi.org/10.1365/s10337-005-0556-1
[65] Prasain, J. K., Jones, K., Brissie, N., Moore, R., Wyss, J. M., & Barnes, S. (2004). Identification of puerarin and its metabolites in rats by liquid chromatography-tandem mass spectrometry. Journal of Agricultural and Food Chemistry, 52(12), 3708–3712. https://doi.org/10.1021/jf040037t
[66] QiuJ. (2007). “Back to the future” for Chinese herbal medicines. Nature Reviews in Drug Discovery".
[67] Rao KR, K. K. (2009). Bioanalytical method validation-A quality assurance auditor view point. J Pharm Sci Res.
[68] Reilly, C. A., Crouch, D. J., Yost, G. S., & Fatah, A. A. (2002). Determination of capsaicin, nonivamide, and dihydrocapsaicin in blood and tissue by liquid chromatography-tandem mass spectrometry. Journal of Analytical Toxicology, 26(6), 313–319. https://doi.org/10.1093/jat/26.6.313
[69] RF, V. (2000). Principles and Practice of Bioanalysis.
[70] S.Romsing. (n.d.). Development and validation of Bioanalytical Method Application to Melatonin and Selected Anti- infective Drugs.
[71] Saari, T. I., Fechner, J., Ihmsen, H., Schüttler, J., & Jeleazcov, C. (2012). Determination of total and unbound sufentanil in human plasma by ultrafiltration and LC-MS/MS: Application to clinical pharmacokinetic study. Journal of Pharmaceutical and Biomedical Analysis, 66, 306–313. https://doi.org/10.1016/j.jpba.2012.03.050
[72] Sayar, E., Sahin, S., Cevheroglu, S., & Atilla H?ncal, A. (2010). Development and validation of an HPLC method for simultaneous determination of trimethoprim and sulfamethoxazole in human plasma. European Journal of Drug Metabolism and Pharmacokinetics, 35(1–2), 41–46. https://doi.org/10.1007/s13318-010-0006-9
[73] Shahrzad, S., Aoyagi, K., Winter, A., Koyama, A., & Bitsch, I. (2001). Pharmacokinetics of Gallic Acid and Its Relative Bioavailability from Tea in Healthy Humans. The Journal of Nutrition, 131(4), 1207–1210. https://doi.org/10.1093/jn/131.4.1207
[74] Shi, B., Yu, Y., Li, Z., Zhang, L., Zhong, Y., Su, S., & Liang, S. (2006). Quantitative analysis of artemether and its metabolite dihydroartemisinin in human plasma by LC with tandem mass spectrometry. Chromatographia, 64(9–10), 523–530. https://doi.org/10.1365/s10337-006-0064-y
[75] Smeriglio, A., Barreca, D., Bellocco, E., & Trombetta, D. (2017). Proanthocyanidins and hydrolysable tannins: occurrence, dietary intake and pharmacological effects. British Journal of Pharmacology, 174(11), 1244–1262. https://doi.org/10.1111/bph.13630
[76] Spaggiari, D., Desfontaine, V., Cruchon, S., Guinchard, S., Vocat, A., Blattes, E., … Decosterd, L. A. (2019). Development and validation of a multiplex UHPLC-MS/MS method for the determination of the investigational antibiotic against multi-resistant tuberculosis macozinone (PBTZ169) and five active metabolites in human plasma. PLoS ONE, 14(5), 1–22. https://doi.org/10.1371/journal.pone.0217139
[77] Sun, D., Dong, L., Guo, P., Yan, W., Wang, C., & Zhang, Z. (2013). Simultaneous determination of four flavonoids and one phenolic acid in rat plasma by LC-MS/MS and its application to a pharmacokinetic study after oral administration of the Herba Desmodii Styracifolii extract. Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences, 932, 66–73. https://doi.org/10.1016/j.jchromb.2013.06.001
[78] Sun, W., Jiang, Z. li, Zhou, L., Chen, R. min, Wang, Z., Li, W. shu, … Chen, R. jie. (2015). Determination and pharmacokinetic study of pirfenidone in rat plasma by UPLC-MS/MS. Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences, 981–982, 14–18. https://doi.org/10.1016/j.jchromb.2014.12.027

[79] Suryawanshi, S., Asthana, R. K., & Gupta, R. C. (2007). Simultaneous estimation of mangiferin and four secoiridoid glycosides in rat plasma using liquid chromatography tandem mass spectrometry and its application to pharmacokinetic study of herbal preparation. Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences, 858(1–2), 211–219. https://doi.org/10.1016/j.jchromb.2007.08.034
[80] Wang M, Lamers RJ, Korthout HA, van Nesselrooij JH, Witkamp RF, van der H. R. (2005). Metabolomics in the context of systems biology: bridging traditional Chinese medicine and molecular pharmacology.
[81] Wang X, Su M, Qiu Y, Ni Y, Zhao T, Z. M. (2007). Metabolic regulatory network alterations in response to acute cold stress and ginsenoside intervention. Journal of Proteome Research.
[82] Wang, X. shuai, Sun, J. chun, Yang, R. na, Ren, J., Liang, S., Sun, M., … Gao, S. G. (2014). Determination of cephalomannine in rat plasma by gradient elution UPLC-MS/MS method. Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences, 963, 70–74. https://doi.org/10.1016/j.jchromb.2014.05.045
[83] Wang, Y., Tang, Y., Gu, J., Fawcett, J. P., & Bai, X. (2004). Rapid and sensitive liquid chromatography-tandem mass spectrometric method for the quantitation of metformin in human plasma. Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences, 808(2), 215–219. https://doi.org/10.1016/j.jchromb.2004.05.006
[84] Wu, H., Xiong, X., Huang, X., Zhu, Z., Huang, F., & Lin, X. (2013). Simultaneous determination of 17 toxic alkaloids in human fluids by liquid chromatography coupled with electrospray ionization tandem mass spectrometry. Journal of Liquid Chromatography and Related Technologies, 36(9), 1149–1162. https://doi.org/10.1080/10826076.2012.685913
[85] Wu, Y. P., Meng, X. S., Bao, Y. R., & Wang, S. (2013). Pharmacokinetic study of four flavones of Glycyrrhiza in rat plasma using HPLC-MS. Journal of Ethnopharmacology, 148(1), 266–270. https://doi.org/10.1016/j.jep.2013.04.024
[86] Xiao, B. X., Feng, L., Cao, F. R., Pan, R. Le, Liao, Y. H., Liu, X. M., & Chang, Q. (2016). Pharmacokinetic profiles of the five isoflavonoids from Pueraria lobata roots in the CSF and plasma of rats. Journal of Ethnopharmacology, 184, 22–29. https://doi.org/10.1016/j.jep.2016.02.027
[87] Xin-Lei, Y., Ming-Biao, L., & Jian-hua, D. (2007). Rapid Determination of nicotine in saliva by liquid phase microextraction-high performance liquid chromatography. Chinese Journal of Analytical Chemistry, 35(2), 171.
[88] Y, H. (2011). Makalah dalam seminar BA-BE.
[89]Yang, B., Yu, Y., Cai, L., Deng, C., & Duan, G. (2006). Determination of apomorphine in canine plasma by liquid chromatography-electrospray ionization mass spectrometry and its application to a pharmacokinetic study. Journal of Separation Science, 29(14), 2173–2178. https://doi.org/10.1002/jssc.200600085
[90] Yang, J., Ding, L., Jin, S., Liu, X., Liu, W., & Wang, Z. (2010). Identification and quantitative determination of a major circulating metabolite of gambogic acid in human. Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences, 878(7–8), 659–666. https://doi.org/10.1016/j.jchromb.2010.01.032
[91] Yasuda, M., Ota, T., Morikawa, A., Mawatari, K. ichi, Fukuuchi, T., Yamaoka, N., … Nakagomi, K. (2013). Simultaneous determination of nicotine and cotinine in serum using high-performance liquid chromatography with fluorometric detection and postcolumn UV-photoirradiation system. Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences, 934, 41–45. https://doi.org/10.1016/j.jchromb.2013.06.028
[92] Ye, L. H., He, X. X., You, C., Tao, X., Wang, L. S., Zhang, M. Di, … Chang, Q. (2018). Pharmacokinetics of nuciferine and N-nornuciferine, two major alkaloids from Nelumbo nucifera leaves, in rat plasma and the brain. Frontiers in Pharmacology, 9(AUG), 1–7. https://doi.org/10.3389/fphar.2018.00902
[93] Zhang, H. G., Sun, Y., Duan, M. Y., Chen, Y. J., Zhong, D. F., & Zhang, H. Q. (2005). Separation and identification of Aconitum alkaloids and their metabolites in human urine. Toxicon, 46(5), 500–506. https://doi.org/10.1016/j.toxicon.2005.06.014
[94] Zhang, H., Hou, Y., Liu, Y., Yu, X., Li, B., & Cui, H. (2010). Determination of mangiferin in rat eyes and pharmacokinetic study in plasma after oral administration of mangiferin-hydroxypropyl-beta-cyclodextrin inclusion. Journal of Ocular Pharmacology and Therapeutics, 26(4), 319–324. https://doi.org/10.1089/jop.2010.0024
[95] Zhang, Q., Zuo, F., Nakamura, N., Ma, C. M., & Hattori, M. (2009). Metabolism and pharmacokinetics in rats of ganoderiol F, a highly cytotoxic and antitumor triterpene from Ganoderma lucidum. Journal of Natural Medicines, 63(3), 304–310. https://doi.org/10.1007/s11418-009-0337-5
[96] Zhang, W. M., Li, R. F., Sun, M., Hu, D. M., Qiu, J. F., & Yan, Y. H. (2014). UPLC-MS/MS method for determination of avicularin in rat plasma and its application to a pharmacokinetic study. Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences, 965, 107–111. https://doi.org/10.1016/j.jchromb.2014.06.015
[97] Zhang, Wei min, Li, R. fang, Qiu, J. fei, Zhang, Z. yin, Wang, H. bo, Bian, L., & Lei, J. hui. (2015). Determination of kurarinone in rat plasma by UPLC-MS/MS. Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences, 986–987, 31–34. https://doi.org/10.1016/j.jchromb.2015.02.005
[98] Zhang, Wenjun, Xu, M., Yu, C., Zhang, G., & Tang, X. (2010). Simultaneous determination of vitexin-4?-O-glucoside, vitexin-2?-O-rhamnoside, rutin and vitexin from hawthorn leaves flavonoids in rat plasma by UPLC-ESI-MS/MS. Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences, 878(21), 1837–1844. https://doi.org/10.1016/j.jchromb.2010.05.023
[99] Zhang, X., Guo, Z., Li, J., Ito, Y., & Sun, W. (2016). A new quantitation method of protodioscin by HPLC-ESI-MS/MS in rat plasma and its application to the pharmacokinetic study. Steroids, 106. https://doi.org/10.1016/j.steroids.2015.12.009
[100] Zhang, Z., Jia, P., Zhang, X., Zhang, Q., Yang, H., Shi, H., & Zhang, L. (2014). LC-MS/MS determination and pharmacokinetic study of seven flavonoids in rat plasma after oral administration of Cirsium japonicum DC. extract. Journal of Ethnopharmacology, 158(PART A), 66–75. https://doi.org/10.1016/j.jep.2014.10.022
[101] Zhang, Z. Q., Liua, W., Zhuang, L., Wang, J., & Zhang, S. (2013). Comparative pharmacokinetics of baicalin, wogonoside, baicalein and wogonin in plasma after oral administration of pure baicalin, Radix Scutellariae and Scutellariae-Paeoniae couple extracts in normal and ulcerative colitis rats. Iranian Journal of Pharmaceutical Research, 12(3), 399–409. https://doi.org/10.22037/ijpr.2013.1331
[102] Zhao, A. qin, Zhao, J. hong, Zhang, S. qing, Pan, Y. yang, & Huo, X. lei. (2016). Determination of parthenolide in rat plasma by UPLC-MS/MS and its application to a pharmacokinetic study. Journal of Pharmaceutical and Biomedical Analysis, 119, 99–103. https://doi.org/10.1016/j.jpba.2015.11.039
[103] Zhao X, Zhang Y, Meng X, Yin P, Deng C, Chen J, Wang Z, X. G. (2008). Effect of traditional Chinese medicine preparation Xindi soft capsule on rat model of acute blood stasis: a urinary metabonomics study based on liquid chromatography-mass spectrometry. Journal of Chromatography B.
[104] Zheng, Z., Li, S., Zhong, Y., Zhan, R., Yan, Y., Pan, H., & Yan, P. (2017). UPLC-QTOF-MS Identification of the Chemical Constituents in Rat Plasma and Urine after Oral Administration of Rubia cordifolia L. Extract. Molecules, 22(8). https://doi.org/10.3390/molecules22081327
[105] Zhu, S., Yan, H., Niu, K., & Zhang, S. (2015). Simultaneous Determination of Seven Components from Hawthorn Leaves Flavonoids in Rat Plasma by LC-MS/MS. Journal of Chromatographic Science, 53(6), 909–914. https://doi.org/10.1093/chromsci/bmu143
[106] Zou, S., Ge, Y., Chen, X., Li, J., Yang, X., Wang, H., … Chang, Y. X. (2019). Simultaneous determination of five alkaloids by HPLC-MS/MS combined with micro-SPE in rat plasma and its application to pharmacokinetics after oral administration of lotus leaf extract. Frontiers in Pharmacology, 10(October), 1–11. https://doi.org/10.3389/fphar.2019.01252
[107] Hui Wang, Guan Ye, Yi-Hong Tang, Hai-Yan Zhu, Rong-Rong Ma, Zhao-Ling Sun and Cheng-Gang Huang. (2006). High-performance liquid chromatographic method for the determination of mangiferin in rat plasma and urine. Biomed. Chromatogr. 20: 1304–1308 (2006). (www.interscience.wiley.com) DOI: 10.1002/bmc.695.
[108] Ramakrishna V. S. Nirogi, Vishwottam N. Kandikere, Manoj Shukla, Koteshwara Mudigonda, Santosh Maurya and Prashanth Komarneni. (2007). Quantification of fexofenadine in human plasma by liquid chromatography coupled to electrospray tandem mass spectrometry using mosapride as internal standard. Biomed. Chromatogr. 21: 209–216 (2007). (www.interscience.wiley.com) DOI: 10.1002/bmc.740.
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Ida Ayumiati. (2021). The SAMPLE PREPARATION AND BIOANALYSIS VALIDATION FOR NATURAL PRODUCT SAMPLE . International Journal of Applied Pharmaceutics, 13(2). Retrieved from https://innovareacademics.in/journals/index.php/ijap/article/view/39034
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