Method development and validation of RP- HPLC in the application of invitro dissolution study of Lamivudine in bulk drug and tablet formulation

D.K.Mandloi, P.K.Tyagi, V.K.Ra

Abstract

A new RP-HPLC method was developed for the determination of Lamivudine in the bulk drug and tablet dosage forms and it was applied for the in-vitro drug dissolution studies. Isocratic elution mode with a mixture of methanol and water in the ratio of (89:11) was selected as the mobile phase with a C18 column (250 x 4.6mm, 5μ) for separation. This mixture was found to be appropriate allowing good elution for the Lamivudine at retention time 2.72 minute at flow rate of 1 ml/min and detection wavelength at 272nm. The linearity was found in the concentration range of Lamivudine 5-100 μg/ml. The liquid chromatography method was extensively validated for linearity, range, accuracy, precision (intermediate precision, repeatability) and specificity. All these analytical validation parameters were observed and the %RSD was determined which indicates the useful of RP-HPLC method for determination of Lamivudine in the bulk drug & tablets dosage form.