Abstract

STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF LAMIVUDINE AND ZIDOVUDINE IN TABLET

Jaykumar P. Joshi* and Dr. Ankit B. Chaudhary

ABSTRACT

A rapid and sensitive stability indicating analytical method was developed for the estimation of Lamivudine and Zidovudine drug by RP-HPLC. The chromatographic separation was achieved on Inertsil (250*4.6 mm, 5 μm) at 35˚C. The separation is achieved employing a Mobile Phase Methanol: Water (65:35) % v/v. The flow rate was 0.80 ml/min. and detection was carried at 254 nm. The individual absorption maxima was found at 246 nm and 278 nm for Lamivudine and Zidovudine respectively. The average retention time was found to be 3 min. for Lamivudine and 4.6 min for Zidovudine. The proposed method was validated for precision, linearity, accuracy, specificity, robustness. All validation parameter were within the acceptable limit. The assay method was found to be linear from 50% to 150% for Lamivudine and Zidovudine. Forced degradation studies on the formulation were conducted by adopting the proposed method to assess the stability of analyte under acid, alkaline, peroxide, thermal and photolytic condition and suitability of method to resolve degradation product.

Keywords: Lamivudine, Zidovudine, RP-HPLC method, Methnol: Water.