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Development and Validation of RP - HPLC Method for Simultaneous Determination of Dicyclomine and Mefanamic Acid
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 × 4.60 × 5im) with mobile phase comprising of 50 mM KH2PO4: 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 ig/ml, 50-250 ig/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.
Keywords
Dicyclomine, Mefanamic Acid, Simultaneous Estimation, HPLC.
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