ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF FEXOFENADINE HCl AND ACEBROPHYLLINE AND MONTELUKAST SODIUM IN BULK AND PHARMACEUTICAL DOSAGE FORM BY RP-HPLC

A reverse phase high-performance liquid chromatography method was developed and validated for the estimation of Acebrophylline, Fexofenadine HCl, Montelukast sodium in bulk drug and pharmaceutical dosage form. The chromatographic determination was performed on Shimadzu with PDA detector. The separation was conducted by using Hypersil BDS (250x4.6,5μm) with mobile phase consisting Phosphate buffer and Acetonitrile (50:50 v/v) ratio. The mobile phase was delivered at the flow rate of 0.7ml/min. The eluent was monitored at wavelength 233 nm and found a sharp and symmetrical peaks with retention time of 2.39, 3.11, 5.26mins. The method was validated for linearity, accuracy, precision, system suitability, and Robustness. The method was found to be linear over the concentration range Acebrophylline 80-160μg/ml, Fexofenadine HCl 5-15μg/ml, Montelukast sodium 100-300μg/ml with coefficient r2 - 0.999. The developed HPLC method was cost effective, precise, specific, accurate and stable. Statistical analysis proves that the method is reproducible, selective and suitable to be applied for analysis of Acebrophylline, Fexofenadine HCl, Montelukast sodium in commercial pharmaceutical dosage form for routine quality control application. Key Words: Acebrophylline, Fexofenadine HCl, Montelukast sodium, HPLC