ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF ACEBROPHYLLINE, FEXOFENADINE HCl, MONTELUKAST SODIUM IN BULK AND MARKETED FORMULATION BY RP-HPLC

A reversed–phase high-performance liquid chromatography method is developed and validated for the determination of Acebrophylline, Fexofenadine HCl, Montelukast sodium in bulk drug and Marketed dosage form. The chromatographic determination was performed on Shimadzu UV win software with variable wavelength detector. The separation was conducted by using ThermoscientficHypersil BDS (150mmx5µm) 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 eluents were monitored at wavelength 233 nm and found a sharp and symmetrical peaks with retention time of 2.39, 3.11,5.26. The method was validated for linearity, accuracy, precision, system suitability. The method was found to be linear over the concentration range 80-160µg/ml, 5-15µg/ml, 100-300µg/ml with coefficient R2 - 0.999. The developed HPLC technique is precise, specific, accurate and stable. Hence this study 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.