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Original Articles

Development and Validation of a RP‐HPLC Method to Quantify Omeprazole in Delayed Release Tablets

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Pages 113-121 | Received 09 Aug 2006, Accepted 15 Sep 2006, Published online: 07 Feb 2007
 

Abstract

An analytical method using a sensitive high performance liquid chromatographic technique was developed to quantify omeprazole in delayed release tablets. The analysis was carried out using a RP‐C18 column with UV‐Vis detection at 280 nm. The mobile phase was diluted with phosphate buffer (pH 7.4) and acetonitrile (70:30 v/v) at a flow‐rate of 1.5 mL·min−1. The parameters used in the validation process were: linearity, range, quantification limit, accuracy, specificity, and precision. The retention time of omeprazole was about 5 min with symmetrical peaks. The linearity in the range of 10.0–30.0 µg/mL presented a correlation coefficient of 0.9995. The excipients in the formulation did not interfere with the analysis and the recovery was quantitative. Results were satisfactory and the method proved to be adequate for quality control of omeprazole delayed release tablets.

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