HPLC测定酶法工艺阿莫西林胶囊中青霉素酰化酶残留量

王炳玲; 张浩; 耿乐乐; 冯玉蓉

doi:10.13748/j.cnki.issn1007-7693.20231946

HPLC测定酶法工艺阿莫西林胶囊中青霉素酰化酶残留量

Determination of Residual Protein in Amoxicillin Capsules Through Enzymatic Process by HPLC

摘要

摘要:
目的采用HPLC测定阿莫西林胶囊中青霉素酰化酶(penicillin G acylace，PGA)残留量。
方法用Bradford法结合液相色谱法定量PGA。以PGA作为标准品，样液经聚合物基质的反向色谱柱分离，用荧光检测器检测，外标法定量。
结果 PGA在0.15~1.50 μg·mL⁻¹内呈良好的一阶线性关系(r=0.9986)。方法检测限和定量限分别为1.5 mg·kg⁻¹和3.0 mg·kg⁻¹，平均回收率>80%。PGA在阿莫西林胶囊内容物样品溶液中24 h内基本稳定。
结论本方法操作简便，具有较好的专属性，回收率高，重复性好，可用于测定酶法工艺阿莫西林胶囊中PGA残留量。

Abstract:
OBJECTIVE To determine the residual penicillin G acylace(PGA) in Amoxicillin capsules by HPLC.
METHODS Bradford method combined with HPLC was used for the quantitative analysis of PGA. Using PGA as the standard, the sample solution was separated by reverse phase chromatography column with polymer matrix, detected by fluorescence detector, and quantified by external standard method.
RESULTS The linear range of PGA was 0.15−1.50 μg·mL⁻¹(r=0.9986). The limits of detection and quantiation were 1.5 mg·kg⁻¹ and 3.0 mg·kg⁻¹. The average recoveries for the target compound were >80%. PGA was basically stable within 24 h in the sample solution of Amoxicillin capsule contents.
CONCLUSION This method is simple, specific, and demonstrates high recovery and reproducibility, making it suitable for determining PGA residues in enzymatically produced Amoxicillin capsules‌.

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