舒喘平胶囊中主要成分的含量测定-中国药品标准.DOCVIP

复方羟丙茶碱去氯羟嗪胶囊中盐酸克伦特罗的含量测定 周震宇 摘要：目的：建立复方羟丙茶碱去氯羟嗪胶囊（舒喘平胶囊）中盐酸克仑特罗含量的方法。方法：采用ZORBAX SB-C18 (4.6 mm×250mm，5μm)色谱柱；甲醇-0.02mol·L-1磷酸二氢钠溶液（用磷酸调节pH至2.5）梯度洗脱；流1.0mL·min-1；检测波长210nm；柱温35；进样量20μL。结果：盐酸克伦特罗的浓度在1.7～6.8μg·mL-1范围内与峰面积呈良好线性关系（r=0.999 9），平均回收率为101.9%.81%（n=9）。结论：建方法简便、准确，可作为复方羟丙茶碱去氯羟嗪胶囊中盐酸克伦特罗的定量分析方法。关键词：复方羟丙茶碱去氯羟嗪胶囊；盐酸克伦特罗；含量测定 Determination of Clenbuterol in Diprophylline Bromhexine Hydrochloride Decloxizine Hydrochloride Raceanisodamine and Clenbuterol Hydrochloride Capsules Zhou Zhenyu (Suzhou Institute for Drug Control, Suzhou 215014) Abstract Objective: To establish a HPLC method for determination of clenbuterol in Diprophylline Bromhexine Hydrochloride Decloxizine Hydrochloride Raceanisodamine and Clenbuterol Hydrochloride Capsules. Methods: The separation was performed on a Zorbax SB-C18 (4.6 mm×250 mm, 5 μm) column at 35℃ with a gradient elution program of methanol-0.02 mol.L-1 sodium dihydrogen phosphate solution (adjusted pH as 2.5 with phosphoric acid) and the flow rate as 1.0 ml·min-1. The detection wavelength was set as 210 nm, and the injection volume is 20 μl. Results: There was the good linearity in the range of 1.7~6.8 μg·mL-1 (r=0.999 9) between the peak area and concentration of Clenbuterol. The average recovery was 101.9%with RSD as 3.81% (n=9). Conclusion: The method is simple and accurate which can be used for determination of clenbuterol in Diprophylline Bromhexine Hydrochloride Decloxizine Hydrochloride Raceanisodamine and Clenbuterol Hydrochloride Capsules. Key words: Diprophylline Bromhexine Hydrochloride Decloxizine Hydrochloride Raceanisodamine and Clenbuterol Hydrochloride Capsules; Clenbuterol; Assay. 复方羟丙茶碱去氯羟嗪胶囊（名舒喘平胶囊，，其成分有二羟丙茶碱、盐酸去氯羟嗪、盐酸克伦特罗、盐酸溴己新以及消旋山莨菪碱[1]。盐酸克伦特罗（lenbuterol，CLB）又名氨哮素、氨双氯醇胺等，俗称“瘦肉精”。盐酸克伦特罗是β-肾上腺素受体激动剂，对支气管平滑肌具有明显的舒张作用。盐酸克伦特罗的药效明显 []，但毒副作用较大[-5]，对心血管、生殖等系统产生不可逆的影响。现[1]未对盐酸克伦特罗含量。为了避免因盐酸克伦特罗过量引起的健康危害，建立盐酸克伦特罗的含量和含量均匀度，以完善该品的质量。1仪器与试 Agilent infinity 1260高效液相色谱仪，包括在线脱气机、四元泵、控温自动进样器、柱温箱、紫外检测器和OpenLab EZChrome