Vierordt法同时测定原料片和复方片剂中呋塞米和螺内酯含量的方法的建立与验证

IF 0.4 Q4 CHEMISTRY, MULTIDISCIPLINARY Acta Chemica Iasi Pub Date : 2018-07-01 DOI:10.2478/achi-2018-0006
R. Chavan, S. Bhinge, M. Bhutkar, D. Randive
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引用次数: 8

摘要

建立了一种简单、方便、适用的分光光度法同时测定速尿和螺内酯联合剂型的方法,并进行了验证。采用联立方程法(Vierordt法)测定呋塞米和螺内酯联合剂型的含量。分光光度法采用双蒸馏水和乙醇以20:80的比例作为溶剂。从线性度、精密度、准确度、检测下限(LOD)和定量下限(LOQ)、回收率和鲁棒性等方面对该方法进行了定量评价。各项参数均在验收范围内。速尿和螺内酯的λmax分别为275 nm和237 nm。速尿和螺内酯在2 ~ 10 μg mL−1的浓度范围内均符合比尔定律。采用该方法对市售制剂的%检测结果表明,速尿的%检测结果为99.60%±0.0500,螺内酯的%检测结果为100.26%±1.17。用联立方程法(Vierordt法)测定呋塞米和螺内酯的总回收率分别为100.38±0.09%和100.49±0.4197%。速尿的LOD和LOQ分别为0.76和2.32 μ mL−1,螺内酯的LOD和LOQ分别为1.99和6.04 μ mL−1。建立了一种简单、方便、精确、快速、准确、经济可靠的分光光度法,用于原料药及制剂中呋塞米和螺内酯的分析。
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Development and Validation of Spectrophotometric Methods for Simultaneous Estimation of Furosemide and Spironolactone by Vierordt’s Method in Bulk and Combined Tablet Dosage Form
Abstract Anew simple, convenient and suitable spectrophotometric method for simultaneous determination of Furosemide and Spironolactone in combined dosage form has been developed and validated. Simultaneous equation method (Vierordt’s method) was used for determination of Furosemide and Spironolactone in combined dosage form. For spectrophotometric method development double distilled water and ethanol were used as a solvent in the ratio of (20:80). The proposed method was quantitatively evaluated in terms of linearity, precision, accuracy, lower limit of detection (LOD) and quantification (LOQ), recovery and robustness. All the parameters were found to be within the acceptance limit. λmax of Furosemide and Spironolactone was found to be 275 and 237 nm respectively. Beer’s law was obeyed over the concentration ranges of 2-10 μg mL−1 for both Furosemide and Spironolactone respectively. The % assay for commercial formulation was found to be 99.60%±0.0500 for Furosemide and 100.26%±1.17 for Spironolactone by the proposed methods. The overall recovery was observed to be 100.38±0.09% for Furosemide and 100.49±0.4197% for Spironolactone by simultaneous equation method (Vierordt’s method). LOD and LOQ were 0.76 and 2.32 μg mL−1 for Furosemide, 1.99 and 6.04 μg mL−1 for Spironolactone. A new simple, convenient, precise, rapid, accurate and economical and reliable spectrophotometric method was developed and validated for the analysis of Furosemide and Spironolactone in bulk drug and their formulations.
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Acta Chemica Iasi
Acta Chemica Iasi CHEMISTRY, MULTIDISCIPLINARY-
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