今日药学

2020, v.30(01) 23-26

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HPLC法测定双羟萘酸曲普瑞林中残留的三氟乙酸
Determination of Trifluoroacetic Acid Residue in Triptorelin Pamoate by HPLC

刘智慧;周庚;郑佳彤;王燕清;徐朋;
LIU Zhihui;ZHOU Geng;ZHENG Jiatong;WANG Yanqing;XU Peng;Livzon Pharmaceutical Group Co.Ltd;

摘要(Abstract):

目的建立新型混合模式色谱柱高效液相色谱法测定双羟萘酸曲普瑞林中三氟乙酸含量,并进行样品测定。方法采用Thermo Acclaim Mixed-Mode WAX~(-1)(150 mm×4.6 mm,5μm)色谱柱;流动相:0.25 mol·L~(-1)磷酸二氢钠溶液(用6 mol·L~(-1)Na OH溶液调节p H值至6.0)∶乙腈(60:40);柱温:30℃;流速:1.0 m L·min~(-1);检测波长:210 nm。结果空白溶剂及供试品中其他组分不干扰三氟乙酸测定,三氟乙酸在0.026~0.080 mg·m L~(-1)范围内线性关系良好,回归方程为:y=1 104.346 0x-0.681 1,r=0.999 8;定量下限为0.8μg;加样平均回收率为98.7%,RSD为1.1%;准确度高;具有良好的重复性;样品中未检出三氟乙酸。结论本方法准确、专属、耐用,可用于双羟萘酸曲普瑞林中三氟乙酸残留的测定。
OBJECTIVE An HPLC method with the New Mixed-Mode Column is established for the determination of trifluoroacetic acid( TFA) residue in Triptorelin Pamoate,the samples are also determined. METHODS HPLC was performed on Thermo Acclaim Mixed-Mode WAX~(-1) column( 150 mm × 4. 6 mm,5 μm) with 0. 25 mol·L~(-1) sodium dihydrogen phosphate solution(adjusted to pH6.0 with 6 mol·L~(-1) NaOH solution) ∶ acetonitrile(60 ∶40) as mobile phase,the column temperature was 30 ℃ .The flow rate was 1.0 m L·min~(-1) and the ultraviolet detection wavelength was 210 nm. RESULTS Blank solvent and other components in samples do not interfere with the determination of trifluoroacetic acid.The standard curve of trifluoroacetic acid was linear in the range of0.026-0.080 mg·m L~(-1),regression equation:y = 1104.346 0 x-0.681 1,r = 0.999 8. The quantitation limit was 0.8 μg. The average recovery rate of method was 98.7%,and RSD was 1.1%. TFA were not detected at Triptorelin Pamoate material. CONCLUSION This method is accurate,specific,durable,and it can be used for the determination of TFA in Triptorelin Pamoate.

关键词(KeyWords): 双羟萘酸曲普瑞林;高效液相色谱法;三氟乙酸;含量测定
triptorelin pamoate;HPLC;trifluoroacetic acid;content determination

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基金项目(Foundation): 广东省引进创新创业团队项目(2016ZT06Y229);; 珠海市引进创新创业团队项目(ZH01110405160002PWC)

作者(Author): 刘智慧;周庚;郑佳彤;王燕清;徐朋;
LIU Zhihui;ZHOU Geng;ZHENG Jiatong;WANG Yanqing;XU Peng;Livzon Pharmaceutical Group Co.Ltd;

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