| 尹美艳,高蓉.泮托拉唑钠肠溶胶囊的质量控制及稳定性研究[J].安徽医药,2016,20(4):664-667. |
| 泮托拉唑钠肠溶胶囊的质量控制及稳定性研究 |
| The study of quality and stability on pantoprazole sodiumenteric-coated capsules |
| 投稿时间：2015-10-16 |
| DOI： |
| 中文关键词: 泮托拉唑钠肠溶胶囊 HPLC法 含量 有关物质 稳定性 |
| 英文关键词: pantoprazole sodium enteric-coated capsules HPLC content related substances stability |
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| 中文摘要: |
| 目的 建立泮托拉唑钠肠溶胶囊含量及有关物质的质量控制方法,并对上市品进行稳定性研究。方法 以Agilent C18柱(250 nm×4.6 nm,5 μm)为色谱柱,流动相为磷酸二氢钠缓冲(1.20 g的磷酸二氢钠溶解于1 000 mL的水中,用磷酸调节pH至7.0)—乙腈(68∶32),流速1 mL·min-1,检测波长288 nm,对胶囊进行有关物质及含量的检测；采用加速试验,在温度(40±2)℃、相对湿度(75±5)%的条件下放置6个月,考察其稳定性。结果 泮托拉唑钠在(1.0～10.0)×10-3 g·L-1浓度范围内线性关系良好,检 测限为0.20 ng,定量限为0.60 ng,平均加样回收率为100.57%(RSD=0.41%),测定样品平均含量为100.67%,有关物质均小于0.2%。稳定性试验结果含量在99.70%～101.16%,有关物质小于0.2% 。结论 该方法快速,简单,稳定,重现性好,可作为泮托拉唑钠肠溶胶囊的含量及有关物质的检测方法。稳定性检测结果符合要求。 |
| 英文摘要: |
| Objective An HPLC method was established for determination of the content of Pantoprazole Sodium Enteric-Coated Capsules and Its Related Substances,and study the stability .Methods The chromatographic separation was performed on Agilent C18(250 nm×4.6 nm,5 μm),Sodium dihydrogen phosphate buffer(dissolved 1.20 g sodium dihydrogen phosphate in 1 000 mL water,and ajust pH 7.0 with phosphoric acid)—acetonitrile=68∶32,the flow rate was 1.0 mL·min-1,the detection wavelength was 288 nm,and detective the related substances and the content . The acceleration test was carried out at temperature(40±2)℃,relative humidity of(75±5)%,and test the result.Results The linear of Pantoprazole Sodium of atorvastatin calcium was(1.0～10.0)×10-3 g·L-1,the limits of detection was 0.20 ng,the limit of quantitation was 0.60 ng,the average recovery was 100.57%(RSD=0.41%),Determination of the sample average content was 100.67%,and the related substance was less than 0.2%. The result of stability test that the content was 99.70%～101.16%,the related substance was less than 0.2%.Coneclusion The method was quick,simple,stable,good repeatability,and it could be used as the content of pantoprazole sodium enteric-coated capsules and its related substances. The stability results conform to the requirement. |
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