丁酸氧钠糖浆中防腐剂含量测定方法的建立与验证

Q4 Chemistry

Proceedings of the National Academy of Sciences of Belarus, Chemical Series Pub Date : 2023-03-05 DOI:10.29235/1561-8331-2023-59-1-26-34

Z. Kuvaeva, S. P. Kacherskaya, O. S. Mastitskaya, E. A. Khvalova

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引用次数: 0

摘要

在高效液相色谱法同时测定防腐剂的基础上，建立了一种简便、快速、灵敏的方法测定氧化丁酸钠糖浆成品剂型中防腐剂(对羟基苯甲酸甲酯、对羟基苯甲酸丙酯)的含量。并对HPLC法进行了验证。在归一化值的80 ~ 120%范围内，该方法的线性相关系数为0.999。在4-羟基苯甲酸甲酯含量0.495 ~ 0.990 mg/ml和4-羟基苯甲酸丙酯含量0.165 ~ 0.330 mg/ml范围内，校准曲线呈线性关系。试验程序的分析特性(选择性、线性、正确性、可重复性、再现性)满足选定的验收标准。

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Development and validation of the method for quantitative determination of preservatives in sodium oxybutyrate syrup

A simple, fast, sensitive method for the determination of preservatives (methyl parahydroxybenzoate, propyl parahydroxybenzoate) in the finished dosage form of sodium oxybutyrate syrup based on the simultaneous determination of preservatives using high performance liquid chromatography (HPLC) is proposed. The HPLC method was validated. The correlation coefficient of the linearity of the technique was 0.999 in the application range of 80–120 % of the normalized value. The calibration graph is linear in the region of 0.495–0.990 mg/ml of methyl 4-hydroxybenzoate and 0.165–0.330 mg/ml of propyl 4-hydroxybenzoate. It has been established that the analytical characteristics of the test procedure (selectivity, linearity, correctness, repeatability, reproducibility) satisfy the selected acceptance criteria.

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来源期刊

Proceedings of the National Academy of Sciences of Belarus, Chemical Series Chemistry-Chemistry (miscellaneous)

CiteScore

0.30

自引率

0.00%

发文量