ANALYTICAL METHOD DEVELOPMENT & VALIDATION OF DICYCLOMINE HCL AND PARACETAMOL BY RP-HPLC

An analytical method for the simultaneous estimation of Dicyclomine Hydrochloride (HCL) and Paracetamol in pharmaceutical dosage forms was developed and validated using Reverse Phase High-Performance Liquid Chromatography (RP-HPLC). The method was optimized to ensure efficient separation and accurate quantification of both drugs. The Waters HPLC system equipped with an auto-sampler and PDA Detector 996 model was used, employing a Phenomenex Gemini C18 column (4.6 mm × 150 mm, 5.0 µm particle size). The mobile phase consisted of methanol and TEA buffer (pH 4.8) in a 32:68 (v/v) ratio, and the column temperature was maintained at 38˚C. The method utilized a flow rate of 1 mL/min and detection at a wavelength of 248 nm. The injection volume was 20 µL, and the total run time was 7 minutes. The method was validated according to ICH guidelines for parameters such as specificity, accuracy, precision, linearity, and robustness. The results demonstrated the method’s suitability for the routine analysis of Dicyclomine HCL and Paracetamol in pharmaceutical formulations, offering a fast, reliable, and cost-effective approach for quality control in the pharmaceutical industry.

Keywords: Dicyclomine Hydrochloride (HCL) and Paracetamol, RP-HPLC, Simultaneous Estimation, Pharmaceutical Dosage Forms, Waters HPLC.