RP-HPLC Method Development and Validation for the Simultaneous Estimation of Amitriptyline Hydrochloride and Pantoprazole Sodium in Bulk and Capsule Dosage Form

摘要

A simple, rapid, accurate and precise isocratic reversed phase high performance liquid chromatographic method has been developed and validated for Simultaneous Estimation of Pantoprazole Sodium (PNT) and Amitriptyline Hydrochloride in Bulk and Capsule Dosage Form. In RP-HPLC method, the analyte were resolved by using isocratic program, methanol and phosphate buffer (80:20v/v) was used as mobile phase, at a flow rate of 0.8 ml/min. on HPLC system containing UV-visible detector with Workstation software and cosmosil 18 (250 mm × 4.6 mm,5 μm) column. The detection was carried out at 244nm. The retention times were 3.21 minutes and 4.20 minutes for Amitriptyline Hydrochloride and Pantoprazole Sodium respectively. Calibration plots were linearity was found 0.9995 and 0.9997 for Amitriptyline Hydrochloride and Pantoprazole Sodium. The method was validated for linearity, precision, accuracy, ruggedness and robustness. The proposed method was successfully used for simultaneous estimation of Amitriptyline Hydrochloride and Pantoprazole Sodium in capsule dosage form. Validation studies revealed that the proposed method is specific, rapid, reliable and reproducible. The high % recovery and low % RSD confirms the suitability of the proposed method for routine quality control analysis of Amitriptyline Hydrochloride and Pantoprazole Sodium in bulk and capsule dosage forms.