Simultaneous Estimation of Lansoprazole and Domperidone in Combined Dosage Form by RP-HPLC

A RP-HPLC method has developed for simultaneous estimation of lansoprazole and domperidone in combined capsule dosage form. Lansoprazole is a proton pump inhibitor and used in the treatment of duodenal and gastric ulcers and gastroesophageal reflux disease (GERD), a condition in which the acid in the stomach washes back up into the esophagus. Sometimes lansoprazole is used in combination with antibiotics to treat ulcers associated with infection caused by the H. pylori bacteria, gastro-oesophageal reflux disease (GERD), peptic ulcer and Zollinger-Ellison syndrome. Domperidone is indicated for treating symptoms associated with upper gastrointestinal motility disorders caused by chronic and sub acute gastritis. It is a gastrointestinal emptying (delayed) adjunct, a peristaltic stimulant and exhibit antiemetic properties.

The mobile phase used was a combination of Acetonitrile: Methanol (81:19). The detection of the combined dosage form was carried out at 280 nm and a flow rate employed was 1 ml/min. The retention time for lansoprazole and domperidone has found to be 2.8 and 1.57 min respectively. Linearity was obtained in the concentration range of 8-24 μg/ml of lansoprazole and 8-24 μg/ml of domperidone with a correlation coefficient of 0.9977 and 0.9992. Detector consists of photodiode array detector; the reversed phase column used was RP-C₁₈ (2.27μm size, 250 mm´4.6 mm i.d.) at ambient temperature. The developed method was validated according to ICH guidelines and values of accuracy, precision and other statistical analysis were found to be in good accordance with the prescribed values. Thus the proposed method was successfully applied for simultaneous determination of domperidone and lansoprazole in routine analysis.