帕拉米韦注射液淋洗水的清洁方法验证

Validation of Cleaning Methods of Rinsing Water of Peramivir Injection

目的：验证用于生产帕拉米韦注射液设备清洁方法的可行性。方法：采用高效液相色谱法,以Phenomenex C18（5μm,4.6 mm×250 mm）柱为色谱柱,0.01 mol/L磷酸二氢钾-甲醇（70∶30）为流动相;检测波长为210 nm;进样量为100μL;流速为1.0 m L/min。结果：检测方法准确度范围在100%~103%之间,系统精密度和方法精密度的RSD%分别为1.0%和0.9%（r=1.000）,最低检测限为2.11 ng/m L。结论：此法适用于帕拉米韦注射液生产设备的清洁。

Objective： To validate the feasibility of cleaning methods for peramivir injection production equipment. Methods： Using Phenomenex C18（5 μm,4.6 mm×250 mm）column, the mobile phase was 0.01 mol/L potassium dihydrogen phosphate-methanol（70：30）; detection wavelength was 210 nm, sample volume was 100 μL and flow rate was 1.0 m L/min. Results： Detecting accuracy range was between 100% and 103%. The RSD% of the system precision and precision of test methods were between 1.0% and 0.9%（r=1.000）, respectively. The minimum detection limit was 2.11 ng/m L. Conclusion： This method is suitable for cleaning peramivir injection production equipment.