摘要
目的建立了HPLC法测定甲硫酸新斯的明注射液有关物质的方法。方法以0.05 mol·L^(-1)磷酸二氢钾溶液(磷酸调节pH至3.0)-乙腈(87∶13)(含0.0015 mol·L^(-1)庚烷磺酸钠)流动相,色谱柱为Agilent HC-C_(8)(4.6×250 mm,5μm),流速为1.0 mL·min^(-1),柱温为30℃,检测波长为215 nm,进样体积为10μL,运行时间为100 min。结果建立的方法系统适用性、专属性、精密度和准确度均符合要求,各杂质在限度25%~120%范围内线性关系良好。结论该测定方法操作简便、准确,可用于甲硫酸新斯的明注射液有关物质的测定。
OBJECTIVE To establish an HPLC method for the determination of related substances in Neostigmine Mesulfate Injection.METHODS The method uses a mobile phase of 0.05 mol·L^(-1) potassium dihydrogen phosphate solution(pH adjusted to 3.0 with phosphoric acid)-acetonitrile(87∶13)(containing 0.0015 mol·L^(-1) sodium heptanesulfonate),Agilent HC-C_(8) column(4.6×250 mm,5μm),flow rate of 1.0 mL·min^(-1),column temperature of 30℃,detection wavelength of 215 nm,injection volume of 10μL,and running time of 100 min.RESULTS The applicability,specificity,precision,and accuracy of the established method system met the requirements,and the linear relationship of each impurity was good within the limit range of 25%to 120%.CONCLUSION This determination method is easy to operate,accurate,and can be used for the determination of substances related to Neostigmine hydrochloride injection.
作者
吴保祥
张发成
蒋雪琴
WU Bao-xiang;ZHANG Fa-cheng;JIANG Xue-qing(Polifarma(Nanjing)Co.,Ltd.,Nanjing 210009,China)
出处
《海峡药学》
2025年第6期19-24,共6页
Strait Pharmaceutical Journal
关键词
甲硫酸新斯的明注射液
HPLC
有关物质
杂质谱分析
Neostigmine hydrochloride injection
HPLC
Related substances
Impurity mass spectrometry analysis
作者简介
吴保祥,硕士,副主任药师;通讯作者:张发成。
