LC-MS检测复方川羚定喘胶囊中添加的醋酸泼尼松

LC-MS Detection of Prednisone Acetate of Compound Chuanlinng Dingchuan Capsules

目的建立检测制剂中醋酸泼尼松的专属性方法。方法采用液相色谱-质谱联用法。选用Venusil MP C18柱,以0.01mol.L-1醋酸铵(含0.1%醋酸)-乙腈(60∶40)为流动相,对非法添加醋酸泼尼松的复方川羚定喘胶囊制剂的提取液进行液相色谱-质谱联用分析。通过与对照品的色谱、紫外及质谱行为相比较,对此类非法添加醋酸泼尼松的药物进行定量测定和定性鉴别。结果在这些制剂中均检出醋酸泼尼松,且回收率为98.62%(n=6)。结论该方法选择性强,灵敏度高,可作为分析检测此类制剂中非法加入的醋酸泼尼松。

OBJECTIVE To develop a specific method for the determination of prednisone aeetate illegally mixed into drug. METHODS The liquid chromatography-mass spectrometry method was used. The Venusil MP C18 enlumn was used with amobile phase was 0.01 mol · L ^-1 ammonium acetate solution（ with 0.1% ）-acetonitrile （60： 40）. Prednisone acetate illegally mixed into drug was identified according to the chromatographic behavior and mass spectral data by comparison with reference substances. RESULTS Prednisone acetate was found in drug. The average recovery was 98.62% （n = 6）. CONCLUSION The method is selective, sensitive and can be used to detect prednisone acetate illegally mixed into drug.