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目的建立一种适用于分析抗HIV融合多肽CP32M含量及有关物质的方法,以及测定其水分和三氟乙酸(TFA)含量的方法。方法采用高效液相色谱法(HPLC)测定CP32M原料药中CP32M的含量。色谱条件:Zor-bax XDB-C18色谱柱,含0.1%TFA的水为流动相A,含0.1%TFA的乙腈为流动相B,梯度洗脱,流速1 ml/min,检测波长214 nm,柱温25℃。采用卡尔菲休库仑滴定法测定水分含量,采用高效液相色谱法测定样品中TFA含量。结果 3批CP32M原料药中,CP32M含量分别为(98.72±0.32)%,(99.48±0.52)%和(99.51±0.31)%(按无水物计算),总有关物质含量为1.07%～1.18%,样品中水分含量为2.99%～3.14%,TFA含量为3.89%～4.23%。结论该方法快速简便,结果准确可靠,可用于CP32M的质量分析。
Objective To establish a method suitable for the analysis of the anti-HIV fusion polypeptide CP32M and its related substances and to determine its water content and trifluoroacetic acid (TFA) content. Methods The content of CP32M in CP32M APIs was determined by high performance liquid chromatography (HPLC). Chromatographic conditions: Zor-bax XDB-C18 column, water with 0.1% TFA as mobile phase A, acetonitrile with 0.1% TFA as mobile phase B, gradient elution at a flow rate of 1 ml / min, detection wavelength 214 nm, Temperature 25 ℃. The Coulometric coulometric titration was used to determine the water content, and the content of TFA in the sample was determined by high performance liquid chromatography. Results The CP32M contents of the three batches of CP32M were (98.72 ± 0.32)%, (99.48 ± 0.52)% and (99.51 ± 0.31)%, respectively, calculated on anhydrous basis with the total content of 1.07% -1.18% , The sample moisture content of 2.99% ~ 3.14%, TFA content of 3.89% ~ 4.23%. Conclusion The method is rapid and simple, the results are accurate and reliable, and can be used for quality analysis of CP32M.