THE ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF DETERMINING THE SODIUM METHYLPARABEN AND SODIUM PROPYLPARABEN IN OMEPRAZOLE CAPSULES

Abstract

Sodium methylparaben and sodium propylparaben are preservatives in omeprazole capsules. According to the Food and Drug Administration (FDA) guidance, the quantities of the specified preservatives are monitored and it is necessary to make an identification and quantitative determination. This article describes the analytical method development and validation for quantitive determination of sodium methylparaben and sodium propylparaben in omeprazole capsules by High Performance Liquid Chromatography (HPLC).

The amount of acid stomach makes reduces by Omeprazole. It's used to treat indigestion, heartburn and stomach ulcers [1].

Sodium methylparaben (sodium methyl para-hydroxybenzoate) and sodium propylparaben (sodium propyl para-hydroxybenzoate) are effective preservatives in many types of compounds. They are used primarily for their bactericidal and fungicidal properties. There is approximately a 1800 time difference between the amounts of omeprazole and paraben in the composition of the capsule. Validation was carried out with the following points: specificity/selectivity; linearity; LOD and LOQ (Limit of Detection and Limit of Quantitation); presicion; robustness. The validation results obtained demonstrate that the HPLC method for the assay of Sodium methyl and propyl parabens in the omeprazole capsules method is found to be specific, linear, precise and robust. After validation the method is accepted for quantitative determination.