摘要
目的通过分析不同厂家硝酸益康唑乳膏的原料及制剂的杂质谱对其处方进行比较,以确定生产、贮存过程中的关键工艺条件,为硝酸益康唑乳膏的质量评价提供支持。方法采用柱切换液质联用方法对不同厂家硝酸益康唑原料及制剂进行杂质谱分析,结合降解实验确定杂质来源。结果不同厂家硝酸益康唑原料及制剂中共检出10种杂质,包括3种辅料杂质、3种工艺杂质以及4种降解杂质。结论硝酸益康唑乳膏中杂质来源复杂,原料制备工艺、制剂处方、内包装、生产环境控制均会影响产品质量,企业应在保证原料质量的基础上,注意避光操作以及生产过程中氧化条件的控制,以避免降解杂质的产生。
OBJECTIVE To analyze the impurity profiles in the active pharmaceutical ingredient(API)and preparations of econazole nitrate ointment from different manufacturers,compare the prescriptions,determine the key process conditions during produc-tion and storage,and thereby provide support for the quality evaluation of econazole nitrate ointment.METHODS Column switching two-dimensional liquid chromatography-mass spectrometry technology was used to analyze the impurities in the API and preparations of econazole nitrate from different manufacturers,and determine the source of impurities through degradation experiments.RESULTS SA total of 10 impurities were detected in the API and preparations of econazole nitrate from different manufacturers,including 3 types of auxiliary impurities,3 process impurities and 4 degradation impurities.CONCLUSION The sources of impurities in econazole nitrate ointment are complex,and the manufacturing process of API,the prescription of formulation,inner packing,production envi-ronment control can all affect product quality.In order to avoid the generation of degradation impurities,enterprises should pay attention to light avoidance operations and oxidizing condition control during the production process while ensuring the quality of raw materials.
作者
陶莉
崇小萌
王立新
张夏
田冶
朱俐
李进
宁保明
TAO Li;CHONG Xiaomeng;WANG Lixin;ZHANG Xia;TIAN Ye;ZHU Li;LI Jin;NING Baoming(National Institutes for Food and Drug Control,Beijing 102629,China)
出处
《中国药学杂志》
北大核心
2025年第19期2058-2070,共13页
Chinese Pharmaceutical Journal
关键词
硝酸益康唑乳膏
杂质谱
柱切换液-质联用
econazole nitrate ointment
impurity profile
column switching LC-MS
