RP-HPLC法测定舒喘平胶囊中3个主要成分的含量

Determination of diprophylline,bromhexine hydrochloride and decloxizine hydrochloride in Shuchuanping capsules by HPLC

目的：建立反相高效液相色谱法测定舒喘平胶囊中二羟丙茶碱、盐酸去氯羟嗪、盐酸溴己新3个主要成分的含量。方法：用碱性处理的十八烷基键合硅胶（BDS）为填充柱，甲醇-水（95：5）为流动相，检测波长240nm。结果：二羟丙茶碱线性范围20．90—62．70μg·mL^-1，回收率99．6％，RSD为0．17％；盐酸去氯羟嗪线性范围6．40-19．20μg·mL^-1，回收率99．7％，RSD为0．54％；盐酸溴已新线性范围1．64—4．99μg·mL^-1，回收率100．0％，RSD为0．34％。结论：本法较简便，准确可靠，可作为舒喘平胶囊的质量控制方法。

Objective：To develop a RP - HPLC method for the separation and determination of a compound preparation consisted of diprophylline, decloxizine hydrochloride and bromhexine hydrochloride in Shuchuanping capsules. Method： MeOH- water（95：5） as the mobile phase and the detection wavelength of 240 nm were adopted. Results： Linear range of diprophylline, bromhexine hydrochloride and decloxizine hydrochloride were 20. 90-62. 70 μg·mL^-1, 6.40- 19.20 μg· mL^-1 and 1.64- 4. 99 μg·mL^-1 respectively. The recoveries of diprophylline, bromhexine hydrochloride and decloxizine hydrochloride were 99.6% （ RSD 0. 17% ） , 99.7% （RSD 0.54% ） and 100. 0% （ RSD 0. 34% ） respectively. Conclusions： The method is simple, sensitive and reliable. It can be used as a quantitative method in quality control of Shuchuanping capsules.