SIMULTANEOUS DETERMINATION OF TIGECYCLINE AND ITS POTENTIAL IMPURITIES BY A STABILITY-INDICATING RP-HPLC-UV DETECTION TECHNIQUE

V. N. V. KISHORE; G. V. RAMANA

doi:10.22159/ijap.2022v14i1.41243

Authors

V. N. V. KISHORE Department of Chemistry, AG and SGS College, Vuyyuru 521165, India
G. V. RAMANA Department of Chemistry, Andhra Loyola College, Vijayawada 520008, A. P., 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: 10 mmol 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 231 nm as wavelength, high-pitched peaks of Tigecycline (Tig) and its impurities (1and2) were detected at 6.55, 8.73 and 4.87 min correspondingly. The linearity of tigecycline and its impurities (impurity-1 and 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 originated to be (1.37,0.047 and 0.071 µg/ml) and (4.15, 0.143 and 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.

References

Kasbekar N. Tigecycline: a new glycylcycline antimicrobial agent. Am J Health Syst Pharm. 2006;63(13):1235-43. doi: 10.2146/ajhp050487, PMID 16790575.

Zhanel GG, Homenuik K, Nichol K, Noreddin A, Vercaigne L, Embil J, Gin A, Karlowsky JA, Hoban DJ. The glycylcyclines: a comparative review with the tetracyclines. Drugs. 2004;64(1):63-88. doi: 10.2165/00003495-200464010-00005, PMID 14723559.

Nguyen F, Starosta AL, Arenz S, Sohmen D, Donhofer A, Wilson DN. Tetracycline antibiotics and resistance mechanisms. Biol Chem. 2014;395(5):559-75. doi: 10.1515/hsz-2013-0292, PMID 24497223.

Pankey GA. Tigecycline. J Antimicrob Chemother. 2005;56(3):470-80. doi: 10.1093/jac/dki248, PMID 16040625.

Kaewpoowat Q, Ostrosky Zeichner L. Tigecycline: a critical safety review. Expert Opin Drug Saf. 2015;14(2):335-42. doi: 10.1517/14740338.2015.997206, PMID 25539800.

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(19):3345-50. doi: 10.1016/s0960-894x(03)00671-1, PMID 12951123.

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(6):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(2):192-9. doi: 10.1093/chromsci/bms126, PMID 22832547.

Suneetha DA. 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;6:1096-107. doi: 10.20959/wjpps20178-9694.

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. Vol. 3; 2018. p. 1-14.

Hua XI, Wei LI. Determination of tigecycline for injection 1with HPLC. Anhui Med Pharm J. 2009;9.

Mohan B, Sharma RSK, Mohan Rao SVM, gopal NVSV. Estimation of related substances in tigecycline by rp-hplc Method. Orient J Chem. 2017;33(5):2608-15. doi: 10.13005/ojc/330558.

Silva LM, Almeida AE, Salgado HR. Thermal analysis and validation of UV and visible spectrophotometric methods for the determination of new antibiotic tigecycline in a 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. J AOAC Int. 2011;94(3):847-56. doi: 10.1093/jaoac/94.3.847, PMID 21797013.

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(2):241-9. doi: 10.1515/pjvs-2017-0029, PMID 28865218.

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(12):1992-2002. doi: 10.1002/bmc.3776, PMID 27245381.

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. Biomed Chromatogr. 2018;32(2):1-2. doi: 10.1002/bmc.4045, PMID 28677837.

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(2):239-53. doi: 10.1556/1326.2016.28.4.2.

Panda SS, BVV RK. Development and validation of spectrophotometric and liquid chromatographic methods for estimation of tigecycline in injections. PCI- Approved-IJPSN. 2020;13(5):5148-54. doi: 10.37285/ijpsn.2020.13.5.12.

International conferences of harmonization validation of analytical procedures test and methodology. Vol. Q2(R1); 2005.

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, Venkata Nadh RV. Rasagiline hemitartrate: synthesis, characterization and RP-HPLC validation for its estimation in bulk form. Drug Invent Today. 2013;5(2):133-8. doi: 10.1016/j.dit.2013.05.002.

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 mianserin using tropaeoline-OOO by ion-pair formation. Int J Appl 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.

KS, KI. 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: 10.22159/ijap.2021v13i3.41028, doi: 10.22159/ijap.2021v13i3.41028.