Abstract

“STABILITY INDICATING UV SPECTROSCOPIC METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF LAMIVUDINE IN BULK AND TABLET DOSAGE FORM”

Rohan Patel*, Nidhi Dave and Raj Patel

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Abstract

To develop and validate a simple and precise stability indicating UV Spectrophotometric method for Lamivudine in the bulk and tablet dosage form. The maximum absorbance was found in Distilled Water: Methanol (50:50) %v/v at 271 nm and found to be a linear over the range 6-14 μg/ml with good correlation (r2) 0.9922. The method was found to be Accurate, Precise and Robust. Lamivudine was subjected to stress conditions such as hydrolysis (acid and base), oxidation, photolysis and thermal degradation. The degraded samples were further analyzed by using this method. Major degradation was observed in acid hydrolysis, photolysis and oxidative conditions. Lamivudine was quite stable under the other stress conditions investigated. Thus, the method is proved to be stability indicating and was found to be an economical, selective and sensitive for the desirable range.

Keywords: Lamivudine, Validation and stability, ICH guidelines, UV-spectroscopy.