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Research Journal of Pharmacy and Technology
Year : 2020, Volume : 13, Issue : 1
First page : ( 15) Last page : ( 21)
Print ISSN : 0974-3618. Online ISSN : 0974-360X.
Article DOI : 10.5958/0974-360X.2020.00003.7

Development and Validation of RP-HPLC Method for Estimation of Stavudine in Bulk and in Capsule Formulation

Dayaramani Richa A.1,*, Dr. Patel Paresh U.2, Dr. Patel N. J.3

1Tolani Institute of Pharmacy, Kutch, Adipur, Gujarat

2Professor, Department of Pharmaceutical Quality Assurance, Shree S. K. Patel College of Pharmaceutical Education and Research, Ganpat University, Kherva, 382711, Gujarat

3Principal, Shree S. K. Patel College of Pharmaceutical Education and Research, Ganpat University, Kherva, 382711, Gujarat

*Corresponding Author E-mail: richa_dayaramani@yahoo.co.in

Online published on 24 February, 2020.

Abstract

Stavudine is Anti-HIV agent, Antimetabolites and Nucleoside and Nucleotide Reverse Transcriptase Inhibitors medication used in the treatment of HIV infection. A simple, selective, precise, accurate and cost-effective reverse phase HPLC method has been developed and validated for estimation of Stavudine Bulk and in dosage form. In the chromatographic conditions, stationary phase is Phenomenex C18 (250 X 4.6mm, 5μm) stationary phase with mobile phase consisting of mixture of water and methanol in the ration of (60: 40 v/v) was used at a flow rate of 1.0mL/min. and column temperature was maintained ambient. Stavudine detected at 266nm by using PDA detector. Injection volume is 20μl. The chromatographic procedure separated Stavudine and potential interfering peaks in an analysis time of 6 min. with Stavudine eluting at about 3 min. The Peak purity plot of Stavudine with purity 0.99999. The developed method was validated with respect to specificity, linearity, accuracy, precision, sensitivity, robustness and solution stability as per ICH guidelines. The proposed method can be used for routine analysis of Stavudine in bulk and in capsule formulation.

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Keywords

Stavudine, Validation, HPLC.

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