Objective:The aim of present work was to develop a RP-HPLC method for simultaneous analysis of Dicyclomine (DCL) and Mefanamic acid (MFA) in a tablet dosage form. Method: Waters Chromatographic system was optimized using a Lichrocart C18 column (250 x 4.60 x 5ìm) with mobile phase comprising of 50 mM KH 2 P0 4 : Acetonitrile in the ratio of 75:25. The flow rate was adjusted to 1.0 ml/min with UV detection at 256 nm. Result: DCL and MFA were eluted with retention times of 7.213± 0.3 min and 11.102± 0.3 min respectively. Beer's Lambert's Law was obeyed over the concentration ranges of 5-25 ìg/ml, 50-250 ìg/ml for DCL and MFA respectively. Conclusion: The high recovery and low coefficients of variation confirm the suitability of the method for simultaneous analysis of both drugs in a tablet dosage form. Statistical analysis proves that the method is sensitive and significant for the analysis of DCL and MFA in pure and in pharmaceutical dosage form without any interference from the excipients. The method was validated in accordance with ICH guidelines.
A simple, specific, accurate and stability-indicating reversed phase high performance liquid chromatographic method was developed for the simultaneous determination of mephenesin and diclofenac diethylamine, using a Spheri-5-RP-18 column and a mobile phase composed of methanol: water (70:30, v/v), pH 3.0 adjusted with o-phosphoric acid. The retention times of mephenesin and diclofenac diethylamine were found to be 3.9 min and 14.5 min, respectively. Linearity was established for mephenesin and diclofenac diethylamine in the range of 50-300 μg/ml and 10-60 μg/ml, respectively. The percentage recoveries of mephenesin and diclofenac diethylamine were found to be in the range of 99.06-100.60% and 98.95-99.98%, respectively. Both the drugs were subjected to acid, alkali and neutral hydrolysis, oxidation, dry heat, photolytic and UV degradation. The degradation studies indicated, mephenesin to be susceptible to neutral hydrolysis, while diclofenac diethylamine showed degradation in acid, H2O2, photolytic and in presence of UV radiation. The degradation products of diclofenac diethylamine in acidic and photolytic conditions were well resolved from the pure drug with significant differences in their retention time values. This method can be successfully employed for simultaneous quantitative analysis of mephenesin and diclofenac diethylamine in bulk drugs and formulations.
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