玛巴洛沙韦原料及制剂的含量测定

闫凯; 孙婷; 袁坤; 赵冬; 王少博; 生丽丹; 刘雪莉; 朱嘉亮

doi:10.13748/j.cnki.issn1007-7693.20233205

玛巴洛沙韦原料及制剂的含量测定

Determination of Raw Materials and Preparations of Baloxavir Marboxil

摘要

摘要:
目的建立玛巴洛沙韦原料及片剂的含量测定方法。
方法采用高效液相色谱法(HPLC)对原料药及片剂的含量进行测定，所用色谱柱为YMC-Triart ExRS C₁₈ (250 mm×4.6 mm，5 μm)，柱温30 ℃；以0.1%磷酸水溶液-乙腈-甲醇(30∶35∶35)为流动相，流速1.0 mL·min⁻¹，检测波长259 nm。
结果主峰与辅料和各杂质峰分离度良好，方法的专属性良好，浓度为198.49~595.498 μg·mL⁻¹时，峰面积与浓度线性关系良好，r为0.9997，回收率为99.80%~101.39%，原料及片剂的平均回收率分别为100.83%及100.29%。
结论建立的方法具合理性、准确性和专属性，可用于玛巴洛沙韦原料及其片剂的含量测定。

Abstract:
OBJECTIVE To establish a method for the determination of baloxavir marboxil raw materials and tablets.
METHODS The contents of baloxavir marboxil was determined by HPLC. The column was YMC-Triart ExRS C₁₈(250 mm×4.6 mm, 5 μm); the mobile phase was 0.1% phosphoric acid-acetonitrile-methyl(30∶35∶35); the column temperature was 30 ℃; the flow rate was 1.0 mL·min⁻¹; the detection wavelength was 259 nm.
RESULTS The main peak was well separated from the excipients and various impurity peaks, indicating good specificity of the method. In the concentration range of 198.49–595.498 μg·mL⁻¹, the linear relationship between the peak area and the concentration was good, with r of 0.9997. The recovery rates ranged from 99.80% to 101.39%, with average recovery rates of 100.83% for the raw materials and 100.29% for the tablets.
CONCLUSION The method is reasonable, accurate and specific, which can be used for the determination of baloxavir marboxil and its tablets.

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