Simultaneous Estimation of Paracetamol, Aceclofenac and Rabeprazole Sodium in Combined Tablet Dosage Form by using RP-HPLC

Abstract

For the simultaneous estimation of Paracetamol, Aceclofenac and Rabeprazole Sodium in combined tablet dosage form, a practical, sensitive RP-HPLC technique has been developed and validated by choosing chromatographic parameters. On Kromasil C18 (250 x 4.6 ID, 5 µm) with mobile phases containing a mixture of Buffer: ACN (50:50 %v/v), isocratic elution mode was used to separate the drugs Paracetamol, Aceclofenac and Rabeprazole Sodium from their process related substances. With a detection wavelength of 285 nm, the flow rate was set to 1 mL/minute, and the injection volume was set at 10 µL with a 8-minute run time. The developed method's appropriateness was examined and confirmed in accordance with the ICH (Q2 R2) guidelines for studies on specificity, Linearity, Accuracy, Precision, Detection limit, Quantification limit and Robustness. Paracetamol, Aceclofenac and Rabeprazole Sodium had retention times of 3.121 minutes, 3.670 minutes and 4.505 minutes, respectively. For Paracetamol, Aceclofenac and Rabeprazole Sodium, linearity was found in the concentration ranges of 65-390 µg/mL, 20-120 µg/mL and 2-12µg/mL, respectively. For Paracetamol, Aceclofenac and Rabeprazole Sodium, the percentage recoveries ranged from 99.13-100.8%, 98.02-10130% and 98012-101.6%, respectively. The method was proven to be useful for determining and validating the presence of Paracetamol, Aceclofenac and Rabeprazole Sodium in combined tablet dosage form.