Development and Validation of Stability Indicating HPLC Method for Lamivudine, Zidovudine and Abacavir in Tablet Dosage Forms

A novel rapid, sensitive and reproducible mass compatible, ultra performance liquid chromatographic method was developed for quantitative determination of Lamivudine, Zidovudine and Abacavir in active pharmaceutical ingredients and its dosage forms. The synthetic nucleoside reverse transcriptase inhibitor analogues Abacavir, Lamivudine and Zidovudine form one of the fixed dosage combinations used in the effective management of HIV. It belongs to a group of anti-HIV medicines called non-nucleoside reverse transcriptase inhibitors (NNRTIs). The method is applicable to the quantification of related compounds of Abacavir, Lamivudine and Zidovudine form one of the fixed dosage combinations. Chromatographic separation of drugs from the possible impurities and the degradation products was achieved on an Inertsil ODS-3V 250 x 4.6 mm, 5.0μm column; the gradient elution achieved with in 90.0 min. Ammonium dihydrogen phosphate and Diammonium hydrogen phosphate buffers pH 3.9 as mobile phase A and methanol as mobile phase B . The flow rate was 1.0 mL/min, column temperature 50°C and the detection was done at 270 nm. The above developed HPLC method was further subjected to hydrolytic, oxidative, photolytic and thermal stress conditions. The performance of the method was validated according to the present ICH guidelines for specificity, limit of detection, limit of quantification, linearity, accuracy, precision, and ruggedness.