Stability Indicating RP-HPLC Method Development and Validation for Simultaneous Estimation of Albendazole and Ivermectin in Pharmaceutical Dosage form

A new simple, precise, selective, accurate and rapid reverse phase high performance liquid chromatographic stability indicating method had been developed and validated for simultaneous quantitative determination of Albendazole and Ivermectin in pharmaceutical dosage form. The chromatographic separation was achieved with Inertsil ODS 150×4.6 mm, 5μm particle size column. The optimized mobile phase consisting of pH 3.5 sodium phosphate buffer: Methanol (25:75v/v) in isocratic mode. The flow rate was 1.0 mL/min and eluents were detected at 245 nm using DAD (or) UV detector. The retention time of Albendazole and Ivermectin were found to be 1.974 and 2.897 mins respectively. The percentage recoveries for Albendazole and Ivermectin were found to be in the range of 98.67 -100.84%,and 101.46 - 100.26%. The calibration curve was constructed between peak area Vs concentration and demonstrated good linear in the range of 40 -200 μg/ml for Albendazole and 0.6-3 μg/ml for Ivermectin. Degradation studies were studied for Albendazole and Ivermectin under various stress conditions such as acid hydrolysis, base hydrolysis, oxidation, and thermal. All the degradation peaks were resolved effectively using developed method with different retention times. The developed method was validated according to ICH guidelines. As the method could effectively separate the degradation products from active ingredient, it can be used for routine analysis of drug in pharmaceutical dosage form.