COMPARATIVE QUALITY EVALUATION OF TWO DIFFERENT COMMERCIAL BRANDS OF PANTOPRAZOLE GASTRO RESISTANT TABLET IP AS PER INDIAN PHARMACOPOEIA MARKETED IN NORTHEAST INDIA
Himakshi Baishya, Barnali Gogoi*, Dr. Parthajyoti Gogoi, Sanjib Kumar Sarma, Ripunjoy Bordoloi
ABSTRACT
The safety and efficacy of a pharmaceutical dosage form can be guaranteed when its quality is reliable. The efficacy of pharmaceutical dosage forms generally depends on their formulation properties, and manufacturing methods, hence it is likely that the quality of dosage form may vary. The aim of our present study is to evaluate the quality of two brands of Pantoprazole Gastro-resistant Tablets I.P 40mg which are marketed in North East region of India whether they qualify the entire test mentioned in Indian Pharmacopoeia thereby suggesting their quality and efficacy for use among the general public. The study was exclusively experimental that used Indian Pharmacopoeia 2014 to check the in vitro quality of Pantoprazole Gastro-resistant Tablets I.P using different analytical techniques and procedure. All the two brands under the study were within the specification for weight variation test for tablet. The test for identification, assay and uniformity of content and dissolution were carried out by High Performance Liquid Chromatography using U-HPLC System (Thermo- Dionex) equipped with an UV detector and stainless steel column (25cm × 4.6mm × 5μm) packed with octadecylsilane chemically bonded to porous silica. The dissolution study was carried out in two stages in Apparatus 1 of I.P. For acid phase, 1000 ml of 0.1M Hydrochloric acid was used as dissolution medium with the speed, temperature and time of apparatus set at 100rpm, 37±0.5°C and 120 minutes respectively. For buffer phase the dissolution medium used was 1000ml of Tris acetate buffer, pH 8.5 with the speed and time of apparatus set at 75rpm and 60 minutes respectively. The research work indicated that two different brands did not show much difference in their results and they were found to be within the acceptance limits.
Keywords: Pantoprazole, Indian Pharmacopoeia, Quality control.
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