Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR LAMIVUDINE AND STAVUDINE PHARMACEUTICAL DOSAGE FORMS BY RP-HPLC

Dr. Paul Richards M., Suchitra D. and *Sandeep Yadav

ABSTRACT

Background: Estimation of Stavudine and Lamivudine is a combination drug of choice used to treat HIV which work by stopping the virus replicating in the body. Both Stavudine and Lamivudine have been found to have synergistic antiretroviral efficacy when used together. act by inhibiting HIV reverse transcriptase and stopping the DNA chain from growing. Objective: The main goal of Simultaneous Estimation of Combined Drugs is to establish the identity, purity, physical characteristics, and potency of the drugs, as well as to demonstrate the suitability of the assay method to provide useful data in order to ensure that the technique produces satisfactory and consistent results. Materials and methods: HPLC grade methanol and water (E. Merck Ltd., Mumbai) were utilized. Hetero Chemicals and Medications Ltd. in Hyderabad provided the pure drugs Stavudine and Lamivudine, which were verified to be 99.5 percent and 99.7 percent pure, respectively. Results: The results were in good agreement with those obtained with official HPLC with absorption maximum of 257 nm by preparing mobile phase 90:10 water: methanol with flow rate 1 ml/min and the retention time of Stavudine and Lamivudine were found to be 5.621 min. and 4.176 min respectively with good resolution by selecting column Zodiac Agilent phase C18, 4.5μ (250 X 4.6 mm) of ambient temperature. All the results obtained with good precise, accurate and robustness as per international conference on Harmonization (ICH) guidelines. Conclusion: The precision (intra-day and inter-day percent RSD >2 for Stavudine and Lamivudine, respectively) and accuracy (99.2-101.5 percent recovery for Stavudine and Lamivudine, respectively) of the approach were evaluated, as well as Robustness and Ruggedness, in accordance with ICH recommendations. The established HPLC method may be employed for simultaneous quantification of Stavudine and Lamivudine in quality control studies and routine analysis due to its simplicity, rapidity, and high precision.

Keywords: Zodiac Agilent C18 Column, of Stavudine and Lamivudine, RP-HPLC.