Abstract

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR THE DETERMINATION OF LAMIVUDINE AND ZUDOVUDINE IN PURE AND TABLETS

Chembeti Sravani*, R. Saravanan and D. Dhachinamoorthi

ABSTRACT

A novel stability indicating, accurate, most precise, rapid and economical reverse phase liquid chromatographic method was developed and validated for the determination of Lamivudine and Zidovudine in pure and tablet dosage forms. Quantification of the selected drugs was conducted with a Kromasil 100-5C18 column [250mm x 4.6mm] using a filtered and degassed mobile phase of composition Methanol and Water (40:60 v/v). The flow rate was 1.0 ml/min and the separation was monitored at 270 nm by utilizing VWD detector. The retention time of Lamivudine and Zidovudine were 3.3 min and 5.0 min respectively. The method was found to be linear over a range of 5-25g/ml for Lamivudine and 10-50 g/ml for Zidovudine. The sample solutions were stressed under different stress conditions and observed that there is no degradation peaks. The proposed method was validated according to the guidelines of (ICH) and was successfully proved to estimate marketed formulations.

Keywords: Lamivudine, Zidovudine, RP-HPLC, Method validation and Stability.