Validation and development of UV-Vis spectrophotometer analysis methods for alpha-tocopherol acetate

Arif Al Iman, Winni Auli, S. Sukrasno
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Abstract

Background: The COVID-19 pandemic had caused the consumption of vitamins in the community to increase with the aim of maintaining immunity in the body. Objective: This study aims to develop an analysis method with a UV-Vis spectrophotometer, which is considered an alternative analysis method that is easier, more practical, and cheaper. Method: Methods for analyzing alpha-tocopherol acetate are validated through specificity tests, linearity measurements, precision tests, accuracy tests, determination of detection limits, determination of quantitation limits, and determination of range using ethanol p.a solvent and UV-Vis Spectrophotometer instruments. Then, examine the alpha tocopherol acetate content of vitamin E dietary supplements. Results: The specificity test showed that matrix had no significant effect on the analysis, the linearity test met the requirements with a concentration range of 20–60 ug/mL (r = 0.9991), the accuracy test was 99.897-100.315%, intraday and interday precision tests were obtained with %RSD less than 2%, the LOD value was 1.859 ug/mL and the LOQ value was 5.635 ug/mL. The determination of levels of vitamin E in dietary supplements showed levels for brand A of 100.508% and brand B of 100.089%. Conclusion: The analytical method developed had met the validation requirements, and the levels of vitamin E food supplements had met the USP requirements. Keywords: method validation, UV-Vis spectrophotometer, alpha tocopherol acetate
紫外-可见分光光度法测定α -生育酚醋酸酯方法的验证与发展
背景:COVID-19大流行导致社区维生素消费增加,目的是维持体内免疫力。目的:本研究旨在建立一种简便、实用、经济的紫外可见分光光度计分析方法。方法:通过特异性试验、线性测量、精密度试验、准确度试验、检出限测定、定量限测定、范围测定等方法,对α -生育酚醋酸酯的分析方法进行了验证。然后,检测维生素E膳食补充剂中α -生育酚醋酸酯的含量。结果:特异性试验表明基质对分析无显著影响,线性试验满足要求,浓度范围为20 ~ 60 ug/mL (r = 0.9991),准确度试验为99.897 ~ 100.315%,日内、日间精密度试验RSD < 2%, LOD值为1.859 ug/mL, LOQ值为5.635 ug/mL。对膳食补充剂中维生素E含量的测定显示,A牌维生素E含量为100.508%,B牌维生素E含量为100.089%。结论:所建立的分析方法符合验证要求,维生素E食品补充剂的含量符合美国药典的要求。关键词:方法验证,紫外可见分光光度计,醋酸α生育酚
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