Monday, 25 August 2014

Stability Indicating HPLC Method Development for Estimation of Montelukast Sodium and Acebrophylline in Combined Dosage Form

Stability Indicating HPLC Method Development for Estimation of Montelukast Sodium and Acebrophylline in Combined Dosage Form: Analysis of pharmaceutical product is very important as it concerned with life. Combination of Montelukast sodium and Acebrophylline is used in bronchial asthama and allergic rhinitis. In this Research work, Montelukast sodium and Acebrophylline stock solution was subjected to acid and alkali hydrolysis, oxidation, thermal photolytic and thermal degradation. In this Stability-Indicating method sample was analyzed by reverse phase C18 column (Hibar Lichrospher® 100, RP-18e 5 μm, 250 mm L × 4.6 mm diameter in size) as stationary phase and Acetonitrile:Methanol (60:40 %v/v, pH 3.2 adjusted with O-phosphoric acid) as a mobile phase at a flow rate of 0.8ml/min. Quantification was achieved at 260 nm with PDA detector. Method was validated according to ICH Q2 R1 guideline. The retention time for Montelukast sodium and Acebrophylline was found to be 15.49 minute and 3.45 minute, respectively. The linearity for Montelukast sodium and Acebrophylline was obtained in the concentration range of 5-25 µg/ml and 100-500 µg/ml with mean accuracies of 99.49-100.81% and 99.45-100.51% respectively. Values of %RSD for Precision Study and Robustness was found < 2%. % label claim was found to be 99.23% for MTKT and 100.83% for ACBR. The developed method meets all the acceptance criteria for the validation of analytical method as per the ICH Q2 R1 guideline. The degraded product peaks were well resolved from the pure drug peak with significant difference in their retention-time values. A simple, precise and accurate stability indicating RP-HPLC method was developed for estimation of Montelukast sodium and Acebrophylline in combined Dosage form.