Comparative In vitro Assessment of Quality Control Parameters of Omeprazole Enteric-Coated Pellets in Capsules from Local Pharmacies in Bangladesh

Abstract

Backgrounds: Omeprazole as enteric coated pellets in capsules form is used for the therapy of gastric and duodenal ulcer. This product is now manufacturing all over Bangladesh for the healthcare of gastric patient. The main objective of this study is to evaluate the quality of Omeprazole Capsules as enteric coated pellets form through ensuring chemical test like assay, dissolution and impurity from 5 pharmaceutical companies from local pharmacies in Bangladesh. Methods The enumerated HPLC (high performance liquid chromatography) methodology of British Pharmacopoeia followed for the metage of assay, impurity and dissolution of Omeprazole Capsules as enteric coated pellets form. Results The assay, impurity and dissolution results of all brands of Omeprazole Capsules as enteric coated pellets form met the specification limit specified in the British Pharmacopeia. Assay results from all brands were between 96.12% ± 1.24 to 101.12% ± 1.01. In case of product release, all the products are treated with pH 4.5 (phosphate buffer) for 45 minutes found from 1.41% ± 2.04 to 7.12% ± 1.24 and the same stressed product treated for pH 6.8 (phosphate buffer) for 45 minutes and found 84.02% ± 0.24 to 97.23% ± 0.84. Omeprazole Impurity C and D are the known identified impurity of Omeprazole Capsules. The content of Omeprazole impurity D was from 0.32% ± 0.21 to 0.12% ± 0.39 and total impurity found from 0.45% ± 0.11 to 0.28% ± 0.09. Omeprazole impurity C was not detected in sample solution. As the results, all the brands sample meet the specification limit of specified monograph so it can be concluded that in terms of quality, integrity and efficacy, pharmaceutical market manufacturing Omeprazole capsules in Bangladesh maintain the highest standard for providing appropriate therapy. Conclusion The results are found satisfactory for both the lower- and top-class pharmaceutical companies in Bangladesh also ensuring the high quality standard for Omeprazole Capsules. This report will help the drug control authority to gather information about the existing quality status of medicine for Omeprazole Capsules as enteric coated pellets form available in different pharmacies of Bangladesh.