Developing and Validating an HPLC Method for Related Substance of Camostat Mesilate in Bulk |Biomedgrid

A simple, accurate, rapid, precise, robust, economical and reproducible stability indicating reverse phase high performance liquid chromatographic (RP-HPLC) method was developed and validated for the determination of related substance of Camostat mesilate in bulk. A stationary phase was used Waters X Bridge Shield RP18, 150mm×4.6mm column with 3.5μ particle dimension for separation, monitor and quantification. Mobile phase A (MP a) is a mixture of 0.05% Trifluelate acid and 0.25M Sodium Sulphate, Mobile phase B(MP b) is Acetonitrile. Elution was gradient mode with flow rate of 1.0ml/min. The validation was carried out as stated by CHP and ICH guiding principle. The calibration curves were linear (r2>0.9995) in the concentration range of 0.2045~4.478μg/ml for CM, 0.2947~3.000μg/ml for impurity A, 0.3538~3.025μg/ml for impurity E, 0.1920~2.619μg/ml for impurity B, 0.2878~4.200μg/ml for impurity C and 0.3538~3.025μg/ml for impurity D, respectively. The LOQ was 0.20μg/ ml for CM, 0.30μg/ml for impurity A, 0.35μg/ml for impurity E, 0.30μg/ml for impurity B,0.20μg/ml for impurity C and 0.20μg/ml for impurity D. the maximum R.S.D. (%) of the content of CE and its each impurity was 2.9% under the deliberate variations in method parameters. The developed procedure was applied to separated and determined the related substances of Camostat Mesilate.