SIMULTANEOUS CONTENT ANALYSIS OF RIFAMPICIN, ISONIAZID, AND PYRAZINAMIDE IN TABLET DOSAGE FORM BY SPECTROPHOTOMETRY ULTRAVIOLET WITH DWM AND RSM

Muhammad Andry, Luthvia Luthvia
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Abstract

Treatment of active tuberculosis requires the use of combinations of drugs. One of the common combination of drugs to serve as anti-tubercular medication is rifampin, isoniazid and pyrazinamide. However, a research conducted by the Food Drug Administration (FDA) concluded that the combination of anti-tubercular medication may pose some patients to the risk of sub-optimal drug exposure, which may lead to less optimal treatment. This study aimed to determine the drug level of combination of anti-tubercular medication, namely rifampin, isomiazid, and pyrazinamide and to develop a spectrophotometric method using the dual wavelength method (DWM) and ratio substaction method (RSM) in tablet preparations on the market without separation. During the preparation, methanol was used as the solvent, followed by dilution, determination of calibration curve, determination of wavelength (λ), measurement, data analysis and validity test with several parameters ranging from linearity, accuracy, precision, LOD, and LOQ. The research revealed that the drug levels of rifampin, isoniazid, and pyrazinamide from the ultraviolet spectrophotometric method using sequential DWM were 100.3±1.8785; 99.98±2.5943; 100.03±2.076 and the results of the ultraviolet spectrophotometric method using RSM sequentially were 99.73±0.5437; 99.84±1.7598; 99.91±1.4762. Both methods succeeded in determining the drug level of the combination of rifampin, isoniazid, and pyrazinamide in tablet preparations without separation and the results of the validation parameters met the requirements.
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DWM和RSM紫外分光光度法同时测定片剂中利福平、异烟肼和吡嗪酰胺的含量
活动性肺结核的治疗需要使用多种药物的组合。作为抗结核药物的常见组合之一是利福平、异烟肼和吡嗪酰胺。然而,美国食品药品监督管理局(FDA)进行的一项研究得出结论,联合使用抗结核药物可能会使一些患者面临次优药物暴露的风险,从而可能导致不太理想的治疗。本研究旨在测定抗结核药物组合,即利福平、异米齐和吡嗪酰胺的药物水平,并开发一种使用双波长法(DWM)和比例-亚作用法(RSM)的分光光度法在市场上的片剂制剂中进行无分离。在制备过程中,以甲醇为溶剂,然后稀释、测定校准曲线、测定波长(λ)、测量、数据分析和有效性测试,测试参数包括线性、准确度、精密度、LOD和LOQ。研究表明,使用连续DWM的紫外分光光度法测得的利福平、异烟肼和吡嗪酰胺的药物水平为100.3±1.8785;99.98±2.5943;100.03±2.076,RSM紫外分光光度法的结果依次为99.73±0.5437;99.84±1.7598;99.91±1.4762。两种方法均成功测定了利福平、异烟肼和吡嗪酰胺联合用药在片剂制剂中的药物水平,无需分离,验证参数结果符合要求。
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发文量
70
审稿时长
12 weeks
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