HPLC 测定盐酸罂粟碱原料药中的有关物质

李颖; 郑志波; 彭朋; 张福利; 林丽娅; 胡江渊; 邵坚芬

doi:10.13748/j.cnki.issn1007-7693.20230961

HPLC 测定盐酸罂粟碱原料药中的有关物质

Determination of the Related Substances in Papaverine Hydrochloride Active Pharmaceutical Ingredients by HPLC

摘要

摘要:
目的建立HPLC检测盐酸罂粟碱原料药中有关物质的方法。
方法采用NanoChrom ChromCore 120 C₈色谱柱，以磷酸二氢钾溶液(3.4 g·L⁻¹磷酸二氢钾水溶液，磷酸调pH至3.5)-乙腈(90∶10)作为流动相A ，甲醇为流动相B，梯度洗脱，流速 0.8 mL·min⁻¹，检测波长 238 nm，柱温50 ℃。
结果主成分与各杂质间最小分离度>1.5；主成分以及其13个杂质在各自的浓度范围内呈良好的线性关系 (r>0.999)；平均回收率为93.1%~101.2%，RSD为 2.3%~8.1%。
结论本方法准确、灵敏、可靠，适用于盐酸罂粟碱原料药有关物质的测定。

Abstract:
OBJECTIVE To establish an HPLC method for determination of the related substances in papaverine hydrochloride.
METHODS NanoChrom ChromCore 120 C₈ column was used; the mobile phase A consisted of 3.4 g·L⁻¹ potassium dihydrogen phosphate aqueous solution, adjust pH to 3.5 with phosphoric acid-acetonitrile(90∶10), the mobile phase B was methanol, with gradient elution at the flow rate of 0.8 mL·min⁻¹; the detection wavelength was 238 nm; the column temperature was 50 ℃.
RESULTS The minimum separation between the main component and each impurity was >1.5; Papaverine and its thirteen impurities showed a good linear relationship in the self-concentration range(r>0.999); and the average recoveries were 93.1%−101.2% with RSDs of 2.3%−8.1%.
CONCLUSION The method is accurate, sensitive and reliable, which is suitable for the determination of related substances in papaverine hydrochloride.

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