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目的研究浓盐酸普鲁卡因注射液含量及杂质对氨基苯甲酸的测定方法。方法采用Grace Smart C_(18)色谱柱(250mm×4.6 mm,5μm)和Agilent Technologies C_(18)色谱柱(250 mm×4.6 mm,5μm);以含0.1%庚烷磺酸钠的0.05mol·L~(-1)磷酸二氢溶液钾溶液(用磷酸调节pH值至3.0)-甲醇(68∶32)为流动相;检测波长:279nm(杂质对氨基苯甲酸检测),290nm(普鲁卡因含量测定);流速:1 ml·min~(-1),进样量:10μl。结果经方法学验证,对氨基苯甲酸在0.1~9.6μg·ml~(-1)范围内有良好的线性关系,回收率为99.6%,RSD为1.9%;浓盐酸普鲁卡因注射液浓度在4.00~40.01μg·ml~(-1)范围内线性关系良好,回收率为101.5%,RSD为1.5%。结论建立的测定方法可行。
Objective To study the method of determination of p-aminobenzoic acid in procaine hydrochloride concentrate and its impurity. Methods The column was calibrated with Grace Smart C_ (18) column (250 mm × 4.6 mm, 5 μm) and Agilent Technologies C_ (18) column (250 mm × 4.6 mm, 5 μm) (-1) dihydrogen phosphate solution of potassium (pH adjusted to 3.0 with phosphoric acid) -methanol (68:32) as the mobile phase; detection wavelength: 279 nm (impurity p-aminobenzoic acid), 290 nm Due to content determination); flow rate: 1 ml · min -1, injection volume: 10μl. The results of the method validation, para-aminobenzoic acid in the range of 0.1 ~ 9.6μg · ml ~ (-1) has a good linear relationship, the recovery was 99.6%, RSD was 1.9%; concentration of concentrated procaine hydrochloride injection The linear range was 4.00 ~ 40.01μg · ml ~ (-1), the recovery was 101.5% and the RSD was 1.5%. Conclusion The established method is feasible.