DEVELOPMENT AND VALIDASI OF CONTENT UNIFORMITY ANALYTICAL PROCEDURE OF GLIPIZIDE EXTENDED RELEASE TABLET
Glipizide is an oral antidiabetic drug belonging to the class of second-generation sulfonylureas. It acts by blocking adenosine triphosphate-sensitive potassium channels in ß-cells of islet of Langerhans on pancreatic cells, which stimulates release of insulin. The extended release (ER) dosage form...
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| Format: | Theses |
| Language: | Indonesia |
| Online Access: | https://digilib.itb.ac.id/gdl/view/78775 |
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| Institution: | Institut Teknologi Bandung |
| Language: | Indonesia |
| Summary: | Glipizide is an oral antidiabetic drug belonging to the class of second-generation sulfonylureas. It acts by blocking adenosine triphosphate-sensitive potassium channels in ß-cells of islet of Langerhans on pancreatic cells, which stimulates release of insulin. The extended release (ER) dosage form of glipizide with its matrix often brings problem in analytical process that shows different yield with the immediate release (IR) one. Based on this case, a specific, easy, and fast analytical procedure suitable for extraction of glipizide in its ER matrices is needed. Samples were prepared by Solid Phase Extrac!ion (SPE) using HLB (Hydrophilic-Lipophilic Balance) sorbent and dissolved in the mobile phase than analysed by A Reversed Phase High Performance Liquid Chromatographic (RPHPLC). The chromatographic separation was achieved on a HPLC YMC Triart C18 (150 x 4.6 mm, ID S-5 um 12nm) column. The mobile phase used was O,IM buffer sodium dihydrogen phosphate monobase pH 6.00 -k 0.05 - methanol in the ratio 55:45 with flow rate of 1.0 mL/min and column temperatue was maintained at 300C. The eluted compound was monitored at a wavelength of 225 nm using a UV detector. The method described herein separated glipizid from all other formulation components within a run time of 23 min. Analytical procedure development was obtain good linearity at range concentration 0.01 — 0.07 mg/mL with the calibration curve of y — 58985.35x + 13.88 and the correlation coefficient of r — 0.9995. The limit of detection (LOD) was 0.0025 mg/mL, while the limit of quantitation (LOQ) was 0.0075 mg/mL. The % RSD the inter-day precision was obtained 0.90%, 1.40% and 0.86%, while the % RSD the intra-day precision was obtained 1.23%. The mean recovery of glipizide placebo spike was 100,68%. Furthermore the method was tried to use in the analysis 2 dose of glipizide ER tablets (5 and 10 mg/tablet). Based on the result of validation method evaluation, it was concluded that the proposed procedure is valid and can be applied for determination content uniformity of glipizide in ER tablet dosage form.
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