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Pharmaceutics
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DEVELOPMENT AND VALIDATION OF NEW UV SPECTROSCOPIC METHODS FOR THE ESTIMATION OF LAMIVUDINE IN ACTIVE PHARMACEUTICAL INGREDIENT AND IN ITS TABLET FORMULATION


Abstract

Author(s): Santosh Gada, Anand Kumar *, Saritha, C. Mallikarjuna Setty

Lamivudine is an FDA approved drug for clinical use for the treatment of HIV infection, AIDS and AIDS-related conditions either alone or in combination with other antiviral agents. In this research work few rapid, simple, accurate and economical UV spectrophotometric methods have been developed and validated for the estimation of the anti-retroviral agent lamivudine in active pharmaceutical ingredient and in its tablet formulation. The λmax of the proposed solvent blends were found to be at 272nm, 282nm, 272nm and shows linearity over the concentration range of1-20μg/mlwith a correlation coefficient of 0.9999, 0.9998, and 0.9997 for three solvent blends viz., Methanol: Double distilled water (3:1); Methanol: Double distilled water: 0.1N HCl (3:1:1); Methanol: Double distilled water: 0.1N NaOH (3:1:1) respectively. All the proposed methods were statistically validated for accuracy, precision, linearity, robustness, and ruggedness as per ICH guidelines. The % RSD values for validated methods were found to less than 2. These methods can be applied for the routine quantitation of lamivudine in API and its tablet formulation.

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