The simple, specific, accurate, precise and reproducible RP-HPLC method have been developed and validated for the simultaneous estimation of dicyclomine HCl and diclofenac sodium. RP – HPLC method was developed using mobile phase:-acetonitrile and 0.050 M potassium dihydrogen phosphate buffer adjusted to pH 7.0 with 0.1N NaOH (65:35 v/v) and stationary phase hypersil BDS C18 column (250 mm x 4.6 mm, 5.0 μm) at wavelength 218 nm and 1 ml/min flow rate. The calibration plot shown r2 0.998 and 0.999, in the concentration range of 10-45 µg/ml and 25 – 112.5 µg/ml for dicyclomine HCl and diclofenac sodium respectively. Accuracy was found to be 99.58% – 101.00% and 99.83% –100.11% respectively. LOD was found to be 1.97 and 1.51 µg/ml for dicyclomine HCl and diclofenac sodium respectively. Retention time was found to be 6.0 min and 4.2 min for dicyclomine HCl and diclofenac sodium respectively. These methods were statistically validated for accuracy, precision, linearity, LOD, LOQ and robustness according to ICH guidelines and can be used for analysis of combined dosage form.
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