Simultaneous Estimation of Pantoprazole and Itopride in Bulk and Pharmaceutical Dosage Forms by RPHPLC Method

Abstract

Objectives: The objective of the present work is to develop and validate a HPLC method with PDA detector to determine Pantoprazole and Itopride in bulk and tablet formulation. Methods: This Chromatographic method uses Phenomenex Luna C18 (4.6 mm × 250 mm) having   particle size (5 µm) column and mobile phase selected after optimization is Methanol: Phosphate Buffer (pH-4.2) (37:63% v/v) with flow rate of 1.0ml/min and detection was carried out at 260 nm. Results: The retention time of the Pantoprazole and Itopride was found to be 2.133, 3.692±0.02 min respectively.  The maximum wavelength (λmax) was found to be 290nm for Pantaprazole and 301 nm for Itopride. Linearity is seen in concentration range of 20-60mg/ml for Pantoprazole and 10-30 mg/ml for Itopride. Validation was performed as per ICH guidelines for linearity, accuracy, precision, LOD and LOQ. The calculated limit of detection (LOD) values were 1.04 and 3.12  μg/mL  and limit of quantitation (LOQ) values were 2.1 and 6.3 μg/mL.The inter-day and intra-day precisions were found to be within limits. The method precision for the determination of Pantaprazole and Itopride was below 2.0%RSD. Conclusion: The present methodunder study is simple yet sensitive, precise, accurate and useful for routine analysis of Pantoprazole and Itopride formulation. This method is simple as diluted samples can be directly used without any preliminary chemical derivatisation or purification steps.