| 高效液相色谱法考察8种常用对照品溶液的稳定性 |
| 投稿时间：2021-01-10 修订日期：2021-05-10 点此下载全文 |
| 引用本文：龚亚,李敏,曹健,樊莉.高效液相色谱法考察8种常用对照品溶液的稳定性[J].药学实践杂志,2021,39(5):426~430 |
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| 基金项目:军队医疗机构制剂标准提高科研专项课题（13ZJZ05-2） |
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| 中文摘要:目的 考察8种常用对照品溶液稳定性，以此确定内控效期。方法 配制对照品储存溶液，密封保存于2～10 ℃冰箱中，于0、1、4、7、10、14、21、28、35 d采用高效液相色谱法测定各对照品储存溶液与新配制的对照品溶液含量，计算含量变化值。结果 各对照品溶液在考察期内，外观与新配制对照品溶液一致；色谱中均未出现显著的杂质峰。甲硝唑、氯霉素和水杨酸混合对照品储存7 d，维生素E对照品、替硝唑和醋酸氯己定混合对照品、磺胺嘧啶对照品、地塞米松磷酸酯对照品储存35 d，含量均符合要求。结论 在2～10 ℃冰箱中，维生素E对照品、替硝唑和醋酸氯己定混合对照品、磺胺嘧啶对照品、地塞米松磷酸酯对照品溶液的效期可定为35 d，甲硝唑、氯霉素和水杨酸混合对照品溶液定为7 d。 |
| 中文关键词:维生素E 新面醑 复方替硝唑溶液 磺胺嘧啶 地塞米松磷酸酯 稳定性 高效液相色谱 |
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| The investigation of the stability of 8 commonly used reference solutions by HPLC |
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| Abstract:Objective To investigate the stability of 8 commonly used reference solutions and determine the validity period of internal control.Methods The storage solutions of reference substances were prepared and stored in the refrigerator at 2 to 10 ℃. The content of the storage solutions and the newly prepared reference solutions were determined by HPLC on days 0, 1, 4, 7, 10, 14, 21, 28 and 35, and their change values of the content were calculated.Results During the inspection period, the appearance of each reference solution was consistent with the newly prepared reference solution. There was no significant impurity peak in the chromatography. For mixed references of metronidazole, chloramphenicol and salicylic acid stored for 7 days, vitamin E, mixed references of tinidazole and chlorhexidine acetate, sulfadiazine, dexamethasone phosphate for 35 days, their contents met the requirements.Conclusion Stored in the refrigerator at 2 to 10 ℃, the effective time period of vitamin E reference solution, mixed references solution of tinidazole and chlorhexidine acetate, sulfadiazine reference, dexamethasone phosphate reference solution can be 35 days, and the mixed references solution of metronidazole, chloramphenicol and salicylic acid defined can be 7 days. |
| keywords:vitamin E new surface Xu compound tinidazole solution sulfadiazine dexamethasone phosphate substance stability HPLC |
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