METHOD DEVELOPMENT, VALIDATION AND CONTENT UNIFORMITY OF RP-HPLC METHOD FOR DETERMINATION OF LANSOPRAZOLE DR PELLETS

An Isocratic RP-HPLC method for the simultaneous determination of Lansoprazole DR pellets has been developed and validated with U.V detection at 210 nm. Lansoprazole is one of the classes of proton pump inhibitors, which reduce gastric acidity, an important factor in healing acid-related disorders such as gastric ulcer, duodenal ulcer and reflux oesophagitis. It is used to treat gastro-oesophageal reflux disease, ulcers, acid-related dyspepsia and as an adjuvant in the eradication of H. pylori. The method utilizes a reversed phase Thermo Hypersil BDS C18 (250 x 4.6 mm, 5?) Column to analyze samples and mobile phase was prepared in the mixture of Phosphate buffer: Methanol in the ratio of 25:75 % v/v. Flow rate was maintained at 1.5 ml/min. column temperature was maintained at Ambient. Retention time of Lansoprazole was found to be 4.37. The average recovery of Lansoprazole was found to be 100.1 %. The described method of Lansoprazole is linear over a range of 59.4μg/ml-178.2 μg/ml and correlation coefficient of Lansoprazole was found to be 0.999. A simple, rapid, precise, stable and accurate liquid chromatographic method (HPLC) was developed. The peak purity index values of standard and sample solutions are within the Acceptance criteria