Stability indicating validated UPLC technique for the simultaneous analysis of raltegravir and lamivudine in pharmaceutical dosage forms

Background

WHO study reveals that approximately 2.1 million people became recently infected with HIV, including 240,000 children below 15 years of age in the year of 2013. Latest FDA approved drug combination of raltegravir and lamivudine, which could be used for the treatment of HIV patients (AIDS). This combination therapy can delay the progress of HIV infection and damage to immune system of the HIV patient. A cost-effective and fast analytical method is required to develop for the research establishment to evaluate quality and storage parameters of the each molecule.

Material and method

A simple and quick approach of stability indicating UPLC technique was established for the simultaneous determination of newly invented anti-HIV drug combo of raltegravir and lamivudine in bulk and pharmaceutical combo within a 4 min of chromatographic run. UPLC separation of the two drugs was attained with a BEH Shield RP18 (2.1 mm × 100 mm, 1.7 μm), analytical column using buffer potassium dihydrogen orthophosphate pH 3 adjusted with orthophosphoric acid:methanol (30:70, %v/v) in isocratic mode at a flow rate of 0.230 ml/min. The column was maintained at an ambient temperature, and detection of two drugs was examined at 254 nm using a PDA detector.

Conclusions

Thus demonstrated technique was exposed for forced degradation studies in five different stress conditions. This projected method was found to be selective and stability indicating, as no obstructing peaks of degradation compounds were detected. The assay of the dosage form and robustness study was obtained within the limit of ICH guidelines.