Abstract

METHOD DEVELOPMENT AND VALIDATION OF SIMULTANEOUS ESTIMATION OF PANTOPRAZOLE SODIUM AND LEVOSULPIRIDE IN COMBINED DOSAGE FORM BY RP-HPLC METHOD

Sai Sruthi Arige, *Sai Datri Arige and Lakshmana Rao A.

ABSTRACT

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 Levosulpiride (LVS) in Combined Dosage Form. The chromatographic separation was carried out on Symmetry C18 column (150 mm x 4.6 mm I.D., 5 μm particle size) with a mixture of methanol, acetonitrile and phosphate buffer pH.9 (60:20:20,v/v/v) as a mobile phase at a flow rate of 1.0 ml/min. PDA detection was performed at 294 nm. The retention times were 4.869 minutes and 3.516 minutes for Pantoprazole Sodium and Levosulpiride respectively. Calibration plots were linear (r2=0.999 for both Pantoprazole Sodium and Levosulpiride respectively) over the concentration range of 24-56 μg/mL for Pantoprazole Sodium and 75-450 μg/ml for Levosulpiride. The method was validated for linearity, precision, accuracy, ruggedness and robustness. The proposed method was successfully used for simultaneous estimation of Pantoprazole Sodium and Levosulpiride in combined 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 Pantoprazole Sodium and Levosulpiride in bulk and tablet dosage forms.

Keywords: Pantoprazole Sodium, Levosulpiride, PNT, LVS, Estimation, HPLC.