徐艳;黄灵勇;李松荷;王东凯;赵云丽;于治国;
XU Yan;HUANG Lingyong;LI Songhe;WANG Dongkai;ZHAO Yunli;YU Zhiguo;School of Pharmacy,Shenyang Pharmaceutical University;

• 1:沈阳药科大学药学院

摘要(Abstract)：

目的建立高效液相色谱法测定依折麦布阿托伐他汀钙片有关物质含量的方法。方法采用ZORBAX RX-C8(250 mm×4. 6 mm,5μm)色谱柱,以50 mmol·L^(-1)醋酸铵缓冲液(冰醋酸调节pH值至4. 1)-乙腈-四氢呋喃(体积比为65∶33∶2)作为流动相A,乙腈作为流动相B,梯度洗脱,流速为1. 5 mL·min(-1)醋酸铵缓冲液(冰醋酸调节pH值至4. 1)-乙腈-四氢呋喃(体积比为65∶33∶2)作为流动相A,乙腈作为流动相B,梯度洗脱,流速为1. 5 mL·min^(-1),进样量为10μL,检测波长为244 nm。柱温为35℃。结果依折麦布及阿托伐他汀与有关物质EZT-A、EZT-B、AT-A、AT-B、AT-C、AT-D、AT-H、AT-I及未知杂质均能良好分离;各有关物质在线性范围内线性关系良好,r≥0. 999 4,回收率为90%(-1),进样量为10μL,检测波长为244 nm。柱温为35℃。结果依折麦布及阿托伐他汀与有关物质EZT-A、EZT-B、AT-A、AT-B、AT-C、AT-D、AT-H、AT-I及未知杂质均能良好分离;各有关物质在线性范围内线性关系良好,r≥0. 999 4,回收率为90%¹08%(RSD≤3%,n=9),经过对3批样品测定,有关物质的含量质量分数均低于限度。结论所建立的方法可作为依折麦布阿托伐他汀钙片有关物质的测定方法。
Objective To develop an HPLC method for determination of the related substances in the ezetimibe atorvastatin calcium. Methods A ZORBAX RX-C8( 250 mm × 4. 6 mm,5 μm) was used with the mobile phase consist of 50 mmol·L108%(RSD≤3%,n=9),经过对3批样品测定,有关物质的含量质量分数均低于限度。结论所建立的方法可作为依折麦布阿托伐他汀钙片有关物质的测定方法。
Objective To develop an HPLC method for determination of the related substances in the ezetimibe atorvastatin calcium. Methods A ZORBAX RX-C8( 250 mm × 4. 6 mm,5 μm) was used with the mobile phase consist of 50 mmol·L^(-1) mmonium acetate buffer( glacial acetic acid adjust pH value to 4. 1)-acetonitrile-tetrahydrofuran( 65∶ 33∶ 2) as mobile phase A and acetonitrile as mobile phase B. The flowrate was 1. 5 mL·min(-1) mmonium acetate buffer( glacial acetic acid adjust pH value to 4. 1)-acetonitrile-tetrahydrofuran( 65∶ 33∶ 2) as mobile phase A and acetonitrile as mobile phase B. The flowrate was 1. 5 mL·min^(-1) and the injection volume was 10 μL,gradient elution. The detection wavelength was set as 244 nm and the column temperature was 35 ℃. Results All the related substances gained a completely chromatographic separation. Good linear relationships of 8 related substances were obtained( r≥0. 999 4) and recoveries were in the range of 90%(-1) and the injection volume was 10 μL,gradient elution. The detection wavelength was set as 244 nm and the column temperature was 35 ℃. Results All the related substances gained a completely chromatographic separation. Good linear relationships of 8 related substances were obtained( r≥0. 999 4) and recoveries were in the range of 90%^(-1)08%( RSD≤3%,n = 9). The content of the related substances in 3 batches of samples were belowthe limit. Conclusion The established method is simple,accurate,highly sensitive and specific,and it can be applied in the determination of ezetimibe atorvastatin calciumand related.

关键词(KeyWords)： 依折麦布阿托伐他汀钙片;有关物质;高效液相色谱法
ezetimibe atorvastatin calcium tablets;related substances;HPLC

Abstract:

Keywords:

基金项目(Foundation):

作者(Authors): 徐艳;黄灵勇;李松荷;王东凯;赵云丽;于治国;
XU Yan;HUANG Lingyong;LI Songhe;WANG Dongkai;ZHAO Yunli;YU Zhiguo;School of Pharmacy,Shenyang Pharmaceutical University;

DOI: 10.14066/j.cnki.cn21-1349/r.2018.11.007

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