SIMULTANEOUS ESTIMATION OF NEW ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF DICYCLOMINE AND DICLOFENAC K BY HIGH PERFORMANCE LIQUID CHROMATOGRAPHY

A simple, precise, and accurate reverse-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the simultaneous estimation of Dicyclomine and Diclofenac Potassium in pharmaceutical dosage forms. Chromatographic separation was achieved using a Phenomenex Gemini C18 column (4.6 × 250 mm, 5 µm) with a mobile phase of Methanol: TEA buffer (65:35 v/v), delivered at a flow rate of 1.0 mL/min. The analysis was performed at a detection wavelength of 230 nm, using a Waters Alliance 2695 HPLC system with PDA Detector (996 model), with a column temperature of 40ºC, injection volume of 10 µL, and a run time of 7 minutes. The method showed excellent linearity, accuracy, precision, and specificity, in compliance with ICH validation guidelines. The retention times of Dicyclomine and Diclofenac Potassium were well-resolved with sharp peaks and no interference from excipients. The method proved to be robust and reproducible, making it suitable for routine quality control analysis of these drugs in bulk and combined dosage forms.

Keywords: Dicyclomine, Diclofenac Potassium, RP-HPLC, Simultaneous Estimation, Analytical Method Validation, Pharmaceutical Dosage Form, Column Chromatography, Method Development.