SIMULTANEOUS DETERMANATION OF TIGECYCLINEAND ITS POTENTIALIMPURITIES BY A STABILITY INDICATING RP-HPLC - UV DETECTION TECHNIQUE

Authors

  • V. N. V. KISHORE Department of Chemistry, AG and SGS College, Vuyyuru 521165, India
  • G. V. RAMANA Department of Chemistry, AG and SGS College, Vuyyuru 521165, India

DOI:

https://doi.org/10.22159/ijap.2022v14i1.41243

Keywords:

Tigecycline, impurities, Forced Degradation, HPLC analysis, Method Justification

Abstract

Objective: Stability representing the RP-HPLC method was established for synchronized quantification of Tigecycline and its impurities. This method was confirmed for its applicability to both tablet dosage and bulk drug forms.

Methods: Intended for an isocratic elution, a mobile phase containing methanol: 10mM Triethylamine Buffer mixture (75:25 v/v, pH 6.1) was used at 1 ml/min flow rate and Agilent ZORBAX Eclipse XDB C18 (250  mm × 4.6  mm, 5 μm) column.

Results: At 231nm as wavelength, high-pitched peaks of Tigecycline (Tig) and its impurities (1&2) were detected at 6.55, 8.73 and 4.87 min correspondingly. The linearity of tigecycline and its impurities (imp-1& 2 and) were estimated with ranging from 75 – 450 µg/mL for Tigecycline and 1–6 µg/mL for both impurity 1 and 2.The corresponding recognition limits (LOD and LOQ) of the tigecycline and its impurities were originate to be (1.37,0.047 & 0.071 µg/ml) and (4.15, 0.143 & 0.126 µg/ml).

Conclusion: The technique was effectively stretched for stability signifying studies under different stress conditions. Justification of the method was done as per the current ICH guidelines.

Downloads

Download data is not yet available.

References

Kasbekar N. Tigecycline: a new glycylcycline antimicrobial agent. Am J Health-Syst Pharm 2006;63:1235-43.

Zhanel GG, Homenuik K, Nichol K, Noreddin A, Vercaigne L, Embil J, Gin A, Karlowsky J.A, Hoban DJ. The glycylcyclines: a comparative review with the tetracyclines, Drugs 2004; 64 ;63–88.

Nguyen F, Starosta AL, Arenz S, Sohmen D, Dönhöfer A, Wilson DN. Tetracycline antibiotics and resistance mechanisms. Biol Chem 2014;395:559-75.

Pankey GA. Tigecycline. J Antimicrob Chemother 2005;56:470-80.

Kaewpoowat Q, Ostrosky-Zeichner L. Tigecycline: a critical safety review. Expert Opin Drug Saf 2015;14:335-42.

Yamashita A, Norton E, Petersen PJ, Rasmussen BA, Singh G, Yang Y, Mansour TS, Ho DM. Muraymycins, novel peptidoglycan biosynthesis inhibitors: synthesis and SAR of their analogues. Bioorg Med Chem lett 2003;13:3345-50.

Sharavanan SPN, Venkatesan CS, Sathiyanarayanan S, Kabilan S. Potential Impurities of Tigecycline: synthesis, isolation, characterization and in vitro pharmacological evaluation. Curr Pharm Anal 2020;16:730-42.DOI : 10.2174/1573412915666190225160030.

Da Silva LM, Salgado HR. Validation of a stability-indicating RP-LC method for the determination of tigecycline in lyophilized powder. J Chromatogr Sci 2013;51:192-9.

Suneetha A, Priyanka GH, Sujitha J. Development and validation of stability indicating RP-HPLC method for estimation of Tigecycline in bulk and its parenteral dosage forms. World J Pharm Pharm Sci 2017;6:1096-7.

Akiful M, Reddy S, Mulagada G, Bakshi V. Development and validation of RP-HPLC method for the estimation of Tigecycline in bulk and its parenteral dosage form. International Conference Series on Multi disciplinary Sciences 2018; 3;1-14.

Hua XI, Wei LI. Determination of tigecycline for injection with HPLC. Anhui Med Pharm J 2009;9.

Mohan B, Sharma RS, Rao SM, Mohan M, Gopal NV. Estimation of related substances in Tigecycline by rp-hplc Method. Orient J Chem 2017;33:2608-15.

Silva LM, Almeida AE, Salgado HR. Thermal analysis and validation of UV and visible spectrophotometric methods for the determination of new antibiotic tigecycline in pharmaceutical product. Adv Anal Chem 2012;2:10-5.

Zorpas KM, Valsami GN, Vryonis EV, Skoutelis AT, Archontaki HA. Robust and sensitive high-performance liquid chromatographic-UV detection technique for the determination of tigecycline in rabbit plasma. JAOAC Int 2011;94:847-56.

Jasiecka-Mikołajczyk A, Jaroszewski JJ. Determination of tigecycline in turkey plasma by LC-MS/MS: validation and application in a pharmacokinetic study. Pol J Vet Sci 2017;20:241–9.

Mei S, Luo X, Li X, Li Q, Huo J, Yang L, Zhu L, Feng W, Zhou J, Shi G, Zhao Z. Development and validation of an LC‐MS/MS method for the determination of tigecycline in human plasma and cerebrospinal fluid and its application to a pharmacokinetic study. Biomed Chromatogr 2016;30:1992-2002.

Shao R , Li X , Hu Y , Chen J , Lou H , Dai H .Determination of tigecycline in human plasma by LC-MS/MS and its application to population pharmacokinetics study in Chinese patients with hospital-acquired pneumonia 2018;32:1-2.

Wang L, Hu X, Zhu H, Zhang X, Wang C, Han Z. Development and validation of an LC–MS/MS method for determination of Tigecycline and its epimer in human plasma and its application in a pharmacokinetic study. Acta Chromatogr. 2016;28:239-53.

Panda SS, BVV RK. Development and validation of spectrophotometric and liquid chromatographic methods for estimation of Tigecycline in injections. Int J Pharma Sci Nanotech 2020;13(5):5148-54. https://doi.org/10.37285/ijpsn.2020.13.5.12

International conferences of harmonization validation of analytical procedures test and methodology. Q2 (R1), (2005), Available from:http://www.ich.org.

Kumar KK, Nadh RV. Reverse phase high performance liquid chromatographic method for the determination of satranidazole in pharmaceutical formulations. Rasayan J Chem 2011;4:681-5.

Sudhir MS, Nadh RV. Rasagiline hemitartrate: Synthesis, characterization and RP-HPLC validation for its estimation in bulk form. Drug Invent Today 2013;5:133-8.

Kumar KK, Nadh RV. A validated RP-HPLC method for the estimation of melphalan in tablet dosage forms. Rasayan J Chem 2011;4:863-7.

Prasad GG, Nadh RV. Determination of mianserine using tropaeoline-OOO by ion pair formation. Int J App Pharm 2019;11:168-73.

Prasad GG, Nadh RV, Kiran KK. Piperacillin estimation by ion-associative complex formation, Asian J Pharm Clin Res 2019;12:1-5.

Shalini K, Ilango K. Development, evaluation and RP-HPLC method for simultaneous estimation of quercetin, ellagic acid and kaempferol in a polyherbal formulation. Int J Appl Pharm 2021;13:183-92. DOI: https://dx.doi.org/10.22159/ijap.2021v13i3.41028.

Published

02-11-2021

How to Cite

KISHORE, V. N. V., & RAMANA, G. V. (2021). SIMULTANEOUS DETERMANATION OF TIGECYCLINEAND ITS POTENTIALIMPURITIES BY A STABILITY INDICATING RP-HPLC - UV DETECTION TECHNIQUE. International Journal of Applied Pharmaceutics, 14(1). https://doi.org/10.22159/ijap.2022v14i1.41243

Issue

Section

Original Article(s)