摘要
目的建立测定止喘灵注射液中盐酸麻黄碱、丁溴东莨菪碱和苦杏仁苷成分含量的高效液相色谱法。方法色谱柱为Waters Sunfire C18柱(250 mm×4.6 mm,5μm),柱温为28℃,流速为1.0 mL/min,流动相为乙腈(A)-0.1%磷酸溶液(B,含0.05%三乙胺和0.02%十二烷基苯磺酸钠,磷酸调节pH至6.0),梯度洗脱,洗脱程序为0~7 min时3%A,7~26 min时3%A^58%A,26~29 min时58%A^3%A,29~34 min时3%A,检测波长为210 nm,进样量为20μL。结果盐酸麻黄碱、丁溴东莨菪碱和苦杏仁苷质量浓度均在0.3~10.0μg/mL范围内与峰面积线性关系良好;平均加样回收率分别为100.66%,99.19%,98.71%,RSD分别为2.58%,2.11%,2.25%(n=6)。结论该方法操作简单、准确可靠、重复性好,可用于止喘灵注射液中盐酸麻黄碱、东莨菪碱和苦杏仁苷的含量测定。
Objective To establish a high performance liquid chromatography(HPLC)method for the determination of ephedrinehydrochloride,scopolamine butylbromide and amygdalin in Zhikeling Injection.Methods Waters sunfire C18 column(250 mm×4.6 mm,5μm)was used for analytical column with temperature settled at 28℃;the flow rate was 1.0 mL/min;the mobile phase was acetonitrile(A)-0.1%phosphoric acid solution(B,containing 0.05%triethylamine and 0.02%sodium dodecylbenzene sulfonate,phosphoric acid adjust pH to 6.0).Gradient elution procedure was 0-7 min 3%A,7-26 min 3%A-58%A,26-29 min 58%A-3%A,29-34 min 3%A.detection wavelength was set at 210 nm and sample size was 20μL.Results The 3 components showed good linear relationships in concentration range of 0.3-10.0μg/mL.The average recoveries of ephedrinehydrochloride,scopolamine butylbromide and amygdalin were 100.66%,99.19%and 98.71%,respectively,the RSDs were 2.58%,2.11%,2.25%(n=6),respectively.Conclusion The method is simple of operation,accurate and reliable,and can be used for the determination of ephedrinehydrochloride,scopolamine butylbromide and amygdalin in Zhikeling Injection.
作者
崔雅慧
金志国
CUI Yahui;JIN Zhiguo(Department of Pharmacy,Beijing Shijitan Hospital,Capital Medical University,Beijing,China 100038)
出处
《中国药业》
CAS
2020年第13期71-73,共3页
China Pharmaceuticals
关键词
高效液相色谱法
止喘灵注射液
盐酸麻黄碱
丁溴东莨菪碱
苦杏仁苷
含量测定
high performance liquid chromatography
Zhikeling Injection
ephedrinehydrochloride
scopolamine butylbromide
amygdalin
content determination