| 张翠兰.高效液相色谱法测定那格列奈胶囊的有关物质[J].安徽医药,2015,19(12):2310-2313. |
| 高效液相色谱法测定那格列奈胶囊的有关物质 |
| Determination of the related substances in Nateglinide capsules by HPLC |
| 投稿时间：2015-04-18 |
| DOI： |
| 中文关键词: 那格列奈胶囊 有关物质 高效液相色谱法 |
| 英文关键词: Nateglinide capsules related substance HPLC |
| 基金项目: |
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| 中文摘要: |
| 目的 建立高效液相色谱法测定那格列奈胶囊有关物质的方法。方法 采用AlltimaTMC18柱(250 mm×4.6 mm,5 μm)色谱柱,以磷酸盐缓冲液(pH=3.0)—乙腈为流动相进行梯度洗脱,流速为1.0 mL·min-1,柱温为30℃,检测波长为210 nm,进样量为20 μL。结果 高效液相色谱法测定有关物质的线性范围均为0.5~10.0 mg·L-1,相关系数均大于0.999(n=6)。结论 该方法简单、精确,有关物质的分离度较好,可以作为那格列奈胶囊有关物质的测定方法。 |
| 英文摘要: |
| Objective To control the related substances in Nateglinide capsules by HPLC. Methods Seperation was performed on an AlltimaTM C18 column (250 mm×4.6 mm,5 μm). The mobile phase was a mixture of ammonium dihydrogen phosphate (pH＝3.0) - acetonitrile with flow rate at 1.0 mL·min-1 and the column temperature was 30℃. The detection wavelength was 210 nm and injection volume was 20 μL. Results There was a good linearity over the range of 0.5~10.0 mg·L-1 with a correlation coefficient greater than 0.999(n=6). Conclusions This method is easy to operate, accurate and highly sensitive , which can be applied to control the related substances in Nateglinide capsules. |
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