"A New RP-HPLC Method for the Simultaneous Determination of Drotaverine Hydrochloride and Paracetamol in a Tablet Dosage Form"

Abstract


 A simple, precise, and accurate isocratic RP-HPLC method was developed and validated for determination of Drotaverine hydrochloride (DROT) and paracetamol (PCM) in bulk drug and tablet formulations. Isocratic RP-HPLC separation was achieved on a Varian Microsorb mv C18 column (250 4.6 mm id, 5 mm particle size) using the mobile phase acetonitrile: water: triethylamine (TEA) (55:45:0.3%) with the pH adjusted to 3.5 and orthophosphoric acid at a flow rate of 1.6 ml/min. The retention time of DROT and PCM were 3.2713 and 1.5735 minutes, respectively. The detection was performed at 230 nm and samples of 20 µl were manually injected. The method was validated for linearity, precision, accuracy, robustness, and specificity. The method was found to be linear in the concentration range of 2-16 µg/ml with a correlation coefficient of 0.9997 for DROT and 12.5-100 µg/ml with a correlation coefficient of 0.9992 for PCM. The Calculated Limit of detection (LOD) and Limit of Quantitation (LOQ) for DROT were 0.0872 and 0.2644 µg/ml, respectively, and for PCM 0.2965 and 0.8984 µg/ml, respectively. The accuracy (recovery) was found to be in the range of 99.13%-101.52% with RSD of 1.194% for DROT and 99.09%-100.33% for PCM with RSD of 1.096%.