制定和批准一种定量测定以气雾剂形式用于药物组合物中的氟利昂中的四氯化碳的分析方法

O. A. Selyutin, D. Shatalov, Dmitry I. Pisarev, O. Novikov, E. Zhilyakova, Victoriya V. Chichulina
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引用次数: 0

摘要

目的是开发和试验一种定量测定以气雾剂形式用于药物组合物的氟利昂中的四氯化碳的分析方法。材料和方法。四氯化碳(四氯甲烷,氟利昂-10)- CCl4, M.m = 153.81,重质,无色,易挥发的液体,有氯仿的甜味。熔点- 22.96 С,沸点- 76.75℃,相对密度在20 - [d]420 1.595。难溶于水(0.5 g/l),可与醇、醚、丙酮、苯(化学纯级)混溶。为确定医药制剂推进剂气体中四氯化碳的存在和定量测定方法,选用了“沙丁胺醇-药典”。采用毛细管柱电子捕获气液色谱法对医药推进剂中的四氯化碳进行了定量鉴定。结果。用该方法测定了“沙丁胺醇”制剂中四氯化碳的含量。对实验结果进行统计处理,得到实验制剂中四氯化碳的含量为0.01580.0007 mg/l。单次实验误差为4.42%,置信概率P = 95%。提出了一种用电子捕获检测器气液色谱法测定气溶胶剂型中四氯化碳杂质含量的方法。该技术涉及气相色谱分离样品,从气溶胶罐,毛细管色谱柱。在这种情况下,最合适的探测器是电子捕获探测器。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Development and approbation of an analytical method for the quantitative determination of carbon tetrachloride in freons used in the composition of medicines in the form of an aerosol
Aim to develop and test an analytical method for the quantitative determination of carbon tetrachloride in freons used in the composition of medicines in the form of an aerosol. Material and methods. Carbon tetrachloride (tetrachloromethane, Freon-10) - CCl4, M.m. = 153.81, heavy, colorless, volatile liquid with a sweet smell reminiscent of chloroform. Melting point - 22.96 С, boiling point - 76.75 C, relative density at 20 - [d]420 1.595. Poorly soluble in water (0.5 g/l), unrestrictedly miscible with alcohol, ether, acetone, benzene (chemically pure grade). To determine the tests for the presence and quantitative determination of carbon tetrachloride in propellant gases used in medicinal preparations, we chose the drug "Salbutamol-Pharmstandard". To identify and quantify carbon tetrachloride in propellants used in medicinal products, the gas-liquid chromatography method with electron capture detection with a capillary column was applied. Results. The developed method was used to determine carbon tetrachloride in the test preparation "Salbutamol". The results were statistically processed and showed that the content of carbon tetrachloride in the test preparation was 0.01580.0007 mg/l. The error of a single experiment with a confidence probability P = 95% was 4.42% Conclusion. We proposed a method for estimating the content of carbon tetrachloride impurities in aerosol dosage forms by gas-liquid chromatography with an electron capture detector. The technique involved the gas chromatographic separation of a sample, taken from an aerosol can, on a capillary chromatographic column. The most appropriate detector in this case turned out to be an electron capture detector.
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