Stability Indicating Rp-Hplc Method for the Estimation of Montelukast in Pharmaceutical Dosage Form

A simple, specific, accurate, precise and stability-indicating reverse phase high performance liquid chromatography (RP-HPLC) method is developed for estimation of montelukast in tablet dosage form. The HPLC method, C-8 Column consisting of (25mm x 4.6mm x 5um – BDS) i.d in isocratic mode, with mobile phase containing 0.01M Potassium di-hydrogen orthophosphate buffer and acetonitrile in the ratio of 35:65 v/v was used. The flow rate was 1mL min and effluent was monitored at 222 nm. Retention time was found to be 3.08min, respectively. The method was validated in terms of Linearity, accuracy, precision, limit of detection (LOD), limit of quantification (LOQ) etc. in accordance with ICH guidelines. Linear regression analysis data for the calibration plot showed that there was good linear relationship between response and concentration in the range of 10 100 μg/ml respectively. The LOD and LOQ values for HPLC method were found to be 0.03 and 0.09 μg/ml respectively. No chromatographic interference from tablet excipients was found. The proposed method was successfully used for estimation of montelukast in tablet dosage form.