盐酸溴己新葡萄糖注射液中盐酸溴己新含量测定方法改进  

Improvement in the Content Determination Method of Bromhexine Hydrochloride in Bromhexine Hydrochloride and Glucose Injection

作　　者：王婷婷 陈乃江 WANG Tingting;CHEN Naijiang(Lianyungang Inspection Testing Center of Food and Drug,Lianyungang,Jiangsu,China 222006)

机构地区：[1]江苏省连云港市食品药品检验检测中心,江苏连云港222006

出　　处：《中国药业》2023年第11期78-80,共3页China Pharmaceuticals

基　　金：江苏省食品药品监督管理局科研项目[20170230]。

摘　　要：目的改进盐酸溴己新葡萄糖注射液中盐酸溴己新的含量测定方法。方法通过更换现行局颁标准YBH10902004-2016Z和YBH04412004-2016Z中的流动相,以及稀释供试品溶液以减少葡萄糖的进样量,改进含量测定方法。色谱柱为Phenomenex Gemini C_(18)柱(250 mm×4.6 mm,5μm),流动相为磷酸盐缓冲液(取磷酸二氢钾1.0 g,加900 mL水使溶解,用0.5 mol/mL氢氧化钠溶液调节pH值至7.0,用水稀释至1000 mL)-乙腈(20∶80,V/V),流速为1.0 mL/min,柱温为40℃,检测波长为249 nm,进样量为10μL。结果盐酸溴己新色谱峰的理论板数均大于2000;盐酸溴己新质量浓度在5.21~83.39μg/mL范围内与峰面积线性关系良好(r=0.9999,n=8);精密度、重复性、稳定性试验结果的RSD均小于2.0%;平均加样回收率为99.54%,RSD为1.53%(n=9)。6批样品中盐酸溴己新的含量为40.31~41.96μg/mL(n=2)。结论所建立的方法操作简便、专属性强、准确度高、重复性好,可用于样品中盐酸溴己新的含量测定。Objective To improve the content determination method of bromhexine hydrochloride in Bromhexine Hydrochloride and Glucose Injection.Methods The content determination method was improved by replacing the mobile phase in the current bureau of standards YBH10902004-2016Z and YBH04412004-2016Z,and diluting the test solution to reduce the injection volume of glucose.The chromatographic column was Phenomenex Gemini C_(18) column(250 mm×4.6 mm,5μm),the mobile phase was phosphate buffer(1.0 g of potassium dihydrogen phosphate was dissolved in 900 mL of water,it was adjusted to pH 7.0 with 0.5 mol/mL of sodium hydroxide solution,and diluted to 1000 mL with water)-acetonitrile(20∶80,V/V),the flow rate was 1.0 mL/min,the column temperature was 40℃,the detection wavelength was 249 nm,and the injection volume was 10μL.Results The theoretical plate numbers of bromhexine hydrochloride chromatographic peaks were all more than 2000.The linear range of bromhexine hydrochloride was 5.21-83.39μg/mL(r=0.9999,n=8).The RSDs of precision,repeatability,and stability test results were lower than 2.0%.The average recovery of bromhexine hydrochloride was 99.54%with an RSD of 1.53%(n=9).The content of bromhexine hydrochloride in six batches of samples was in the range of 40.31-41.96μg/mL(n=2).Conclusion The established method is simple,specific,accurate,and reproducible,which can be used for the content determination of bromhexine hydrochloride in samples.

关 键 词：盐酸溴己新葡萄糖注射液 盐酸溴己新 含量测定 

分 类 号：R927.2[医药卫生—药学] R974.1