Abstract

DEVELOPMENT AND VALIDATION OF RP-UHPLC METHOD FOR SIMULTANEOUS ESTIMATION OF LAFUTIDINE AND DOMPERIDONE IN PHARMACEUTICAL TABLET DOSAGE FORM

Ashwini Shrikrushna Taware*, Rajendra S. Bandal, Dr. K. K. Meena, Ajay Sorty

Abstract

A simple, rapid, selective, sensitive, linear, precise and accurate RPUHPLC method was developed and validated for simultaneous estimation of Lafutidine and Domperidone in pharmaceutical tablet dosage form. Separation of the drugs was achieved on a reverse phase by shim-pack C18: 250 x 4.6 mm, 3μm, column at 30˚c temperature using a mobile phase consisting of [Methanol: Ammonium Acetate Buffer pH 4.8, 20mM (75:25% v/v)] at a flow rate of 0.7 ml/min was employed. The RP- UHPLC detection wavelength was 220 nm and 10μL of sample was injected. The linearity was found for Lafutidine (35- 60g mL-1) and Domperidone (105-180 g mL-1) with a correlation coefficient of 0.999. Retention times were 4.2 min and 5.0 min for Lafutidine and Domperidone respectively. The method was validated as per the ICH guidelines for its selectivity, system suitability study, specificity, linearity, range, precision, accuracy, limit of detection, limit of quantification, robustness, ruggedness, assay. The percentage RSD for precision and accuracy of the method was found to be less than 2%. The method was successfully employed for routine quality control analysis of Lafutidine and Domperidone in Pharmaceutical formulation.

Keywords: Ultra-High-Performance Liquid Chromatography, Linearity, Precision, Accuracy, Calibration.