PENETAPAN KADAR RACIKAN KAPSUL YANG MENGANDUNG AMINOFILIN, CTM, DAN PREDNISON

Ratnaningsih Sri Hariyati, Sri Hartati Yuliani
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Abstract

The assay of active pharmaceutical ingredients (API) of compounding preparation is needed to assure the effectivity and safety of the pharmaceutical therapy. This research aims to assay determination of API in compounding capsules of aminophylline, chlorpheniramine maleate (CTM), and prednisone. The assay is done by UV spectrophotometry with Partial Least Square (PLS) multivariate calibration to thirty compounding capsules taken from Apotek “X” in Sleman. The result of the assay of aminophylline is 56,983% - 137,89%, CTM - 159,59% - 131,01%, and prednisone 32,31% - 245,79%. The Farmakope Indonesia 6th Edition assay requirement of aminophylline is 93,0% – 107,0%; CTM 90,0% - 110,0%; and prednison 90,0% - 110,0% of the label amount. The result shows that thirty samples of compounding capsules don’t meet the requirements stated by Farmakope Indonesia 6th Edition.
复方制剂的活性成分分析是保证药物治疗有效性和安全性的重要手段。本研究旨在测定氨茶碱、马来酸氯苯那敏(CTM)和强的松复方胶囊中原料药的含量。采用偏最小二乘(PLS)多变量校准紫外分光光度法对30粒复方胶囊进行测定。氨茶碱含量为56,983% ~ 137,89%,中药含量为159,59% ~ 131,01%,强的松含量为32.31% ~ 245,79%。印度尼西亚Farmakope第6版氨茶碱检测要求为93.0% - 107.0%;CTM 90,0% - 110,0%;而强的松则是标签量的90% - 110%。结果表明,30个复方胶囊样品不符合《印尼法马科第6版》的要求。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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