A SIMPLE AND FAST RP-UHPLC-PDA METHOD FOR DETERMINATION OF ISRADIPINE FROM POLYMERIC NANOCAPSULES

Abstract

A simple and fast analytical method of ultra-high performance liquid chromatography (UHPLC) was developed and validated in order to assay isradipine in poly(ε-caprolactone) (PCL)/polyethylene glycol (PEG) nanocapsules. Experiments were performed by UHPLC on a C18 chromatographic column at 25°C using a mobile phase composed by methanol and water (85:15 v/v) with a flow rate of 0.5 mL.min−1 and UV detection at 327nm for achieving a total run time of 1.5 min. The UHPLC method was validated according to the guidelines set on The International Conference on Harmonisation. It proved to be selective, linear (r = 0.99962), precise (RSD < 4.1%), and accurate (recovery rates between 95.24 and 96.53%) at the range from 10 to 40 µg.mL−1. The performance was robust when slight changes in the flow rate, wavelength of detection, and mobile phase composition were tested. It was successfully applied to quantify isradipine from nanoparticulate polymeric systems, showing high loading efficiency rates, greater than 98.55%. These results provided an experimental basis to use this method for quantifying isradipine with reliable results, besides being very fast, easy to perform and cheaper.

Keywords: analytical method validation, neuroprotective effect, pharmaceutical quality control, polymeric nanocapsules

References

1. Lachman L, Lieberman HA, Kaning JL. Teoria e Prática na Indústria Farmacêutica, Lisboa: Fundação Calouste, 2001.
2. La Roca MF, Soares Sobrinho JL, Nunes LCC, Rolim Neto PJ. Desenvolvimento e Validação de Método Analítico: Passo Importante na Produção de Medicamentos. Rev Bras Farm 2007;88:177-180.
3. Kumar A, Saini G, Nair A, Sharma R. UPLC: a Preeminent Technique in Pharmaceutical Analysis. Acta Pol Pharm 2012;69(3):371-380.
4. Chan CS, Guzman, JN, Ilijic E, Mercer JN, Rick RC, Tkatch T, et al. ‘Rejuvenation’ protects neurons in mouse models of Parkinson’s disease. Nature 2007;447:1081­1089.
5. Parkinson Study Group STEADY-PD III Investigators. Isradipine Versus Placebo in Early Parkinson Disease: A Randomized Trial. Ann Intern Med 2020;172(9):591-598.
6. Singh R, Lillard Jr JW. Nanoparticle-based targeted drug delivery. Exp Mol Pathol 2009;86:215-223.
7. Deng S, Gigliobianco MR, Censi R, Di Martino P. Polymeric Nanocapsules as Nanotechnological Alternative for Drug Delivery System: Current Status, Challenges and Opportunities. Nanomaterials (Basel). 2020;10(5):E847.
8. Yang X, Xu H, Gan J, Li L, Li J, Jin Y, Yuan B. Quantitative determination of isradipine in dog plasma by an ultra performance liquid chromatographyetandem mass spectrometry method. Asian J Pharm Sci 2013;8:312-313.
9. Aswini GL, Dachinamoorty D, Babu YR, Surekha ML, Swamy GK. Development and validation of isradipine in bulk and in its pharmaceutical formulations by RP-HPLC method. Int Res J Pharm 2012;3(9):131-133.
10. Chaitanya KK, Sankar DG, Israel DS, Lakshmi AV, Kumar CHN. Isocratic-Reverse Phase Liquid Chromatographic method for the quantification of isradipine by UV detection in tablets. Eur J Appl Eng Sci Res 2012;1(4):220-227.
11. Rao RN, Nagaru P, Srinivasulu C, Krishnamurthy PR, Sireesha D, Bhaskar SU. Reverse phase HPLC method for the estimation of isradipine in pharmaceutical dosage forms. Asian J Chem 2005;17:1406-1410.
12. Al-Suwayeh SA. Quick, simple, and sensitive HPLC methos for determination of isradipine in plasma and its application in pharmacokinetic studies. Analytical Letters 2002;35(7):1205-1213.
13. Fessi H, Puisieux F, Devissaguet JP, Ammoury N, Benita S. Nanocapsule formation by interfacial polymer deposition following solvent displacement. Int J Pharm 1989;55(1):R1-R4.
14. Gelperina S, Maksimenko O, Khalansky A, Vanchugova L, Shipulo E, Abbasova K, et al. Drug delivery to the brain using surfactant-coated poly(lactide-co-glycolide) nanoparticles: influence of the formulation parameters. Eur J Pharm Biopharm 2010;74:157-163.
15. ICH (The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use) Q2 (R1). Validation of Analytical Procedures: Text and Methodology, 2005.
16. Petersson P, Forssenb P, Edstromc L, Samie F, Tattertone S, Clarke A, Fornstedt T. Why ultra high performance liquid chromatography produces more tailing peaks than high performance liquid chromatography, why it does not matter and how it can be addressed. J Chromatogr A 2011;1218:6914-6921.
17. Nadal JM, Toledo MG, Pupo YM, de Paula JP, Farago PV, Zanin SMW. A Stability-Indicating HPLC-DAD Method for Determination of Ferulic Acid into Microparticles: Development, Validation, Forced Degradation, and Encapsulation Efficiency. J Anal Methods Chem.2015;2015:1–10.
18. Gomes MLS, Klein T, Simionatto M, Nadal JM, Zanin SMW, Borsato DM, et al. A simple RP-HPLC/UV method for determination of cilostazol in polymeric nanoparticles suspensions: development and validation. Acta Pharm. 2015;34:803-809.
19. Almeida MA, Nadal JM, Klein T, de Paula JP, Budel, JM, Novatiski A, Campessato EA, et al. Innovative phytoformulation containing capsaicinoids: Microparticles development, analytical method validation, and anti-ulcer effect.Pharmacogn. Mag.2018;14:290-296.
20. Gaspar MDR, Lyra AM, Camargo GA, Nadal JM, Teitelbaum AP, dos Santos FA, et al. Development and Validation of a Reversed-Phase UHPLC-PDA Methodfor Determination of Chlorhexidine in Meth(Acrylic) Nanocapsules. Lat. Am. J. Pharm. 2020;39(4):792-798.
21. Lyra AM, Nadal JM, Klein T, Farago PV. Development and Validation of a Simple RP-HPLC Methodfor Determination of Efavirenz in Polymeric Microparticles. Lat. Am. J. Pharm. 2017;36(12):2354-2362.
22. Lopes CE, Langoski G, Klein T, Ferrari PC, Farago PV. A simple HPLC method for the determination of halcinonide in lipid nanoparticles: development, validation, encapsulation efficiency, and in vitro drug permeation. Braz. J. Pharm. Sci. 2017;53:1-9.
23. Cartagena-Molina AF, Klein T, Lyra AM, Urban AM, Farago PV, Campanha NH. Development and validation of an RP-HPLC/UV method for determination of miconazole nitrate in spray-dried polymeric microparticles. Acta Farmacéutica Bonaerense. 2016;35:1354-1360.
24. Ramasahayam B, Eedara BB, Kandadi P, Jukanti R, Bandari S. Development of Isradipine Loaded Self-Nano Emulsifying Powders for Improved Oral Delivery: In Vitro and in Vivo Evaluation Drug Dev Ind Pharm. 2015;41(5):753-763.
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Barbosa, F. M., G. dos A. Camargo, A. M. Lyra, J. M. Nadal, and P. V. Farago. “A SIMPLE AND FAST RP-UHPLC-PDA METHOD FOR DETERMINATION OF ISRADIPINE FROM POLYMERIC NANOCAPSULES”. Asian Journal of Pharmaceutical and Clinical Research, Vol. 13, no. 8, Aug. 2020, pp. 225-9, doi:10.22159//ajpcr.2020.v13i8.38817.
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