STABILITY INDICATING RP-HPLC AND HPTLC METHODS FOR THE DETERMINATION OF ZANAMIVIR IN BULK AND DOSAGE FORM

Authors

  • C. H. Bhirud Pravara Institute of Medical Sciences Deemed University(PIMS), Loni, Maharashtra, India.
  • D. H. Nandal

Keywords:

Zanamivir, Reverse phase high performance liquid chromatography, High pressure thin layer chromatography, Virenza capsule, Method development and validation, Stability indicating

Abstract

Objective: To develop a simple, precise, accurate, validated stability indicating reverse phase high-pressure liquid chromatography and high-performance thin layer chromatography method for the determination of zanamivir in bulk and capsule dosage form.

Methods: The high-pressure liquid chromatography separation was achieved on Agilent TC C18 (2) 250 x 4.6 mm, 5 μ column using mobile phase composition of methanol-0.02 M phosphate buffer, pH 3.5, 50:50 (v/v). Flow rate was maintained at 1 ml/min at an ambient temperature. Quantification was achieved with ultraviolet detection at 230 nm. The retention time obtained for zanamivir was at 3.6 min. The method employed thin layer chromatography aluminum plates precoated with silica gel 60F-254 as the stationary phase. The solvent system consisted of chloroform: methanol: acetic acid (4.5:0.5:0.3v/v) and then scanned. The system was found to give a compact spot for zanamivir (Rf value of 0.29±0.02).

Results: In HPLC,the result obtained with the detector response was found to be linear in the concentration range of 2-12 μg/ml. In HPTLC, the linear regression analysis data for the calibration plots showed a good relationship with r2=0.9999±0.0001 in the concentration range 500-3000 ng/spot. The reliability and analytical performance of the proposed methods, including linearity, range, precision, accuracy, detection and quantitation limits, were statistically validated. When zanamivir was subjected to different stress conditions; the proposed methods could effectively separate the drug from its degradation products, and were thus considered as good stability-indicating procedures.

Conclusion: It is concluded that this method can be applied for routine quality control of zanamivir in dosage forms as well as in bulk drug.

Keywords: Zanamivir, Reverse phase high-performance liquid chromatography, High-pressure thin layer chromatography, Virenza capsule, Method development and validation, Stability indicating

Downloads

Download data is not yet available.

References

www.drugbank.ca/sys/fda_labels/DB00558. [Last accessed on 10 Feb 2016].

Cass LM, Efthymiopoulos C, Marsh J, Bye A. Effect of renal impairment on the pharmacokinetics of intravenous Zanamivir. Clin Pharmacokinet 1999A;36:13-9.

Freund B, Gravenstein S, Elliott M, Miller I. Zanamivir: a review of clinical safety. J Drug Saf 1999;21:267-81.

Hayden F, Klimov A, Tashiro M, Hay A, Monto A, McKimm-Breschkin J, et al. Neuraminidase inhibitor susceptibility network position statement: antiviral resistance in influenza a/H5N1 viruses. Antivir Ther 2005;10:873–7.

www.columbia.edu/itc/hs/medical/pathophys/id/2005/MID40HammerAntivirals BW.pdf. [Last accessed on 10 Feb 2016].

Bhaskar reddy CM, Subbareddy GV. A validated UV spectrophotometric determination of an antiviral drug zanamvir from tablet formulations. J Chem Pharm Res 2012;4:3624-27.

Boonyapiwat B, Steventon GB, Sarisuta N, Ma Y. Validated HPLC method for zanamivir and its application to in vitro permeability study in caco-2 culture model. Indian J Pharm Sci 2011;73:564-8.

Reddy RY, Harika KSL, Sowjanya S, Swathi E, Soujanya B, Reddy SS. Estimation of zanamivir drug present in tablets using RP-HPLC method. Int J PharmTech Res 2011;3:180-6.

Lindegardh N, Hanpithakpong W, Kamanikom B, Farrar J, Hien TT, Singhasivanon P, et al. Quantification of the anti-influenza drug zanamivir in plasma using high-throughput HILIC–MS/MS. Bioanalysis 2011;3:157-65.

ICH, Stability Testing of New Drug Substances and Products. Q1A (R2); 2005.

ICH, Photostability Testing of New Drug Substances and Products. Q1B; 2005.

Baertschi SW, Jansen PJ, Alsante KM. Pharmaceutical stress testing: predicting drug degradation. Informa Healthcare; 2005.

ICH, Validation of Analytical Procedures: Text and Methodology. Q2(R1); 2005.

Sethi PD. HPTLC: quantitative analysis of pharmaceutical formulation. CBS Publications; 1996. p. 162-65.

Published

01-07-2016

How to Cite

Bhirud, C. H., and D. H. Nandal. “STABILITY INDICATING RP-HPLC AND HPTLC METHODS FOR THE DETERMINATION OF ZANAMIVIR IN BULK AND DOSAGE FORM”. International Journal of Pharmacy and Pharmaceutical Sciences, vol. 8, no. 7, July 2016, pp. 249-56, https://innovareacademics.in/journals/index.php/ijpps/article/view/11805.

Issue

Section

Original Article(s)