使用高效液相色谱法测定从制药生产设备收集的拭子上对乙酰氨基酚、咖啡因和盐酸屈他维林的残留量，以支持清洁验证。
Determination of residues of acetaminophen, caffeine, and drotaverine hydrochloride on swabs collected from pharmaceutical manufacturing equipment using HPLC in support of cleaning validation.
作者信息
Hassouna Mohamed E M, Issa Yousry M, Zayed Ashraf G
机构信息
Beni Suef University, Faculty of Science, Chemistry Department, Beni Suef, Egypt.
出版信息
J AOAC Int. 2014 Sep-Oct;97(5):1439-45. doi: 10.5740/jaoacint.12-475.
An HPLC method was developed for the simultaneous determination of residues of acetaminophen (paracetamol, PA), caffeine (CA), and drotaverine HCl (DH) on swabs collected from pharmaceutical manufacturing equipment surfaces. The challenge in cleaning validation is to develop analytical methods that are sensitive enough to detect traces of the active compounds remaining on the surface of pharmaceutical manufacturing equipment after cleaning. Chromatography was performed in the isocratic mode on a Hypersil C18 BDS column using the mobile phase 0.02 M tetrabutylammonium bisulfate-methanol (100 + 45, v/v) at 50°C with UV detection at 210 nm. The method was tested for specificity, linearity, LOD, LOQ, accuracy, and precision for determination of traces of the above-mentioned drugs. The time required for a single analysis was 12 min. The response was linear in the ranges of 6.900-52.100, 1.040-7.800, and 0.694-5.210 μg/mL for PA, CA, and DH, respectively.
建立了一种高效液相色谱法，用于同时测定从制药生产设备表面采集的拭子中对乙酰氨基酚（扑热息痛，PA）、咖啡因（CA）和盐酸屈他维林（DH）的残留量。清洁验证面临的挑战是开发足够灵敏的分析方法，以检测制药生产设备表面清洁后残留的痕量活性化合物。采用等度洗脱模式，在Hypersil C18 BDS柱上进行色谱分析，流动相为0.02 M硫酸氢四丁铵 - 甲醇（100 + 45，v/v），柱温50°C，于210 nm波长处进行紫外检测。对该方法进行了特异性、线性、检测限、定量限、准确度和精密度测试，以测定上述药物的痕量。单次分析所需时间为12分钟。PA、CA和DH的响应分别在6.900 - 52.100、1.040 - 7.800和0.694 - 5.210 μg/mL范围内呈线性。
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