Abstract

STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF LANSOPRAZOLE AND DOMPERIDONE IN BULK AND ITS PHARMACUTICAL DOSAGE FORM BY RP-HPLC

Shoyeb Ahmed*and R. Vani

ABSTRACT

A simple, selective, linear, precise, and accurate stability indicating RP-HPLC method was developed and validated for the simultaneous estimation of Lansoprazole and Domperidone from bulk and formulations. Chromatographic separation was achieved isocratically on a Waters C8 column (150×4.6 mm, 3.9 μ particle size) using a mobile phase, (OPA: Methanol) pH adjusted to 2.2 with orthophosphoric acid in the ratio of 80:20 v/v. The flow rate was 1ml/min and effluent was detected at 235nm. The retention time of Lansoprazole and domperidone were 1.4 and 3.1 min respectively. Linearity was observed in the concentration range of 50-150μg/ml for Lansoprazol and Domperidone. Percent recoveries obtained for both the drugs were 100.00%. The percentage RSD for precision and accuracy of the method was found to be less than 2%. The method was validated according to the ICH guidelines with respect to specificity, linearity, accuracy, precision, LOD and LOQ. The method developed was successfully applied for the analysis of simultaneous estimation of Lansoprazole and Domperidone capsules. Lansoprazole and domperidone were exposed to acid, base, peroxide, thermal and photolytic stress conditions and the stressed samples were analyzed by proposed method.

Keywords: Lansoprazole, Domperidone, Methanol, Phosphate buffer, orthophosphoric acid.