| 摘要: |
| 目的 青霉素酰化酶(PGA)是阿莫西林胶囊酶法工艺中的关键催化剂，其作为外源性抗原在药物中的残留量分析是药物杂质控制的难点。方法 本文采用高效液相色谱法(HPLC)测定阿莫西林胶囊中酶蛋白残留量，方法以青霉素酰化酶作为标准品，用荧光检测器检测，外标法定量。结果 青霉素酰化酶在0.15μg·mL-1~1.50 μg·mL-1范围内呈良好的一阶线性关系，相关系数r大于0.996。方法检测限和定量限分别为1.2 mg·kg5-1和3.0 mg·kg-1，平均回收率在80%以上，相对标准偏差(RSD)小于5%。PGA在阿莫西林样品溶液中24h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，重现性好，可用于测定酶法工艺阿莫西林胶囊中青霉素酰化酶残留量。 |
| 关键词: 阿莫西林胶囊 高效液相色谱法 蛋白 残留 |
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| Determination of Residual Protein in Amoxicillin Capsules through Enzymatic Process by High Performance Liquid Chromatography |
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wangbingling
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Hebei Ji’an Testing Service company limited
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| Abstract: |
| OBJECTIVE Penicillin G acylace (PGA) is a critical catalytic enzyme utilized in the amoxicillin Production by the enzymatic process. It’s one of the Exogenous residual proteins in drugs.The analysis of residue protein is the difficulty of drug impurity control. METHODS In this study, a High Performance Liquid Chromatography(HPLC) was established for Determination of Residual Protein in Amoxicillin Capsules.RESULTS In this method, penicillin G acylase was used as the standard substance, detected by fluorescence detector, and quantified by external standard method. RESULTS The Linear range of penicillin G acylase was 0.15μg·mL-1~1.5 μg·mL-1, The correlation coefficient r is greater than 0.996. 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 Greater than 80 %，with RSDs less than 5 %. PGA in amoxicillin test solution was basically stable within 24 hours. CONCLUSION The method is simple to operate, has good specificity, high recovery rate and good reproducibility, and can be used for the determination of penicillin acylase residue in amoxicillin capsules by enzymatic process. |
| Key words: amoxicillin capsules HPLC protein residual |
