STABILITY INDICATING HPLC METHOD FOR THE ESTIMATION OF LAMIVUDINE AND STAVUDINE IN COMBINED DOSAGE FORM
Ankit Kushwaha, Avinash Krishnarao Kondalkar, Muraree Lal
ABSTRACT
This study presents the development and validation of a stability-indicating HPLC method for the simultaneous estimation of Lamivudine (LAMI) and Stavudine (STAV) in combined dosage forms. The method demonstrated excellent linearity with correlation coefficients of 0.9990 for LAMI and 0.999 for STAV across specified concentration ranges. Recovery studies indicated high accuracy, with mean recoveries of 98.08% to 98.91% for LAMI and 98.48% to 99.03% for STAV at different recovery levels. The method exhibited high precision, as evidenced by low %R.S.D. values across various validation parameters. Sensitivity was confirmed through low LOD (0.12 µg/ml for LAMI; 0.10 µg/ml for STAV) and LOQ (0.40 µg/ml for LAMI; 0.25 µg/ml for STAV). Forced degradation studies showed that both drugs maintained stability under standard conditions, although they were susceptible to degradation under acidic and alkaline environments. The validated HPLC method is robust and suitable for routine quality control of LAMI and STAV in pharmaceutical formulations, ensuring the reliability of therapeutic products.
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