Abstract
Omeprazole is a potent proton pump inhibitor for the treatment of various acid-related gastrointestinal disorders. simple, selective and rapid reversed phase high performance liquid chromatographic (RP-HPLC) method for the analysis of Omeprazole has been developed and validated. The separation was achieved from HPLC column (ZORBAX, XDB, C-18 (150×4.6 mm, 5 micron) with a mobile phase consisting of HPLC grade acetonitrile and phosphate buffer solution (pH 7.4) in the ratio of (60:40 v/v) at a flow rate of 0.5 ml/min and runtime 10 min with UV detector at 302nm. The method was specific and it was observed that no interference with diluents. The proposed method was accurate with 100.95% recovery omeprazole and precise (% RSD of area of system precision, % RSD of assay of method precision were found to be 0.14% and 0.37% respectively). From the linearity study the correlation coefficient is found to be 0.9988, which indicated that the method was linear over 25% to 175% range. The method was found robust for possible changes. Therefore, this method can be used as a more convenient and efficient option for the analysis of Omeprazole to establish the quality of the drug substance during routine analysis with consistent and reproducible results.
Highlights
Omeprazole is a proton pump inhibitor used in the treatment of dyspepsia, peptic ulcer disease (PUD), Gastro esophageal reflux disease (GORD/GERD), and Laryngopharyngeal reflux (LPR) and Zollinger–Ellison syndrome
The developed method was found to be suitable for the estimation of omeprazole in bulk and capsule dosage forms
Above 0.995 and relative standard deviation for six preparations was found below 2.0% which shows that the analytical method is more accurate and precise throughout its range of 10 μg mL-1 to 70 μg mL-1 of omeprazole
Summary
Omeprazole is a proton pump inhibitor used in the treatment of dyspepsia, peptic ulcer disease (PUD), Gastro esophageal reflux disease (GORD/GERD), and Laryngopharyngeal reflux (LPR) and Zollinger–Ellison syndrome. [1]. Decreasing excess stomach acid can help relieve symptoms such as heartburn, difficulty swallowing, persistent cough, and trouble sleeping It can prevent serious acid damage to your digestive system (e.g., ulcers, cancer of the esophagus). A method for the determination of omeprazole in bulk and capsule dosage form by reverse phase high performance liquid chromatography has been developed. This is a simple, rapid, precise and an accurate method. The developed method was found to be suitable for the estimation of omeprazole in bulk and capsule dosage forms [10] the study was aimed to develop a rapid, simple, precise and accurate High performance liquid chromatographic (HPLC) method for the determination of Omeprazole in pharmaceutical formulations (capsules)
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