应用离子色谱法测定奥硝唑氯化钠注射液中亚硝酸盐的含量

Determination of Nitrite Content in Ornidazole and Sodium Chloride Injection by Using Ion Chromatography

目的建立离子色谱法(IC)测定奥硝唑氯化钠注射液中亚硝酸盐的含量测定方法,为奥硝唑氯化钠注射液的质量控制提供一种可行方法。方法Dionex IonPac AS_(18)(4 mm×250 mm)为分析柱,以KOH溶液为淋洗液进行等度洗脱,检测器:电导检测器,采用抑制型电导检测。结果亚硝酸根的线性范围为0.49995~47.9952μg·mL^(-1),亚硝酸根的平均回收率(n=9)为103.6%,RSD为1.7%。结论该法简便、准确、快速,可用于奥硝唑氯化钠注射液中亚硝酸根的含量测定。

OBJECTIVE To establish an ion chromatography method for the determination of nitrite content in Ornidazole and Sodium Chloride Injection and provides a feasible method for quality control of the drug.METHODS The chromatographic column was Dionex IonPac AS_(18)(4 mm×250 mm),adopting isocratic elution of KOH,suppression conductivity detector was used.RESULTS The linear range of nitrite was 0.49995-47.9952μg·mL^(-1).The average recoveries(n=9)of nitrite was103.6%,with RSD of 1.7%.CONCLUSION The method is accurate and fast,and can be used for determination of nitrite content in Ornidazole and Sodium Chloride Injection.