甲磺酸多沙唑嗪片剂的含量、含量均匀度和溶出度的测定

HPLC for determination of doxazosin in tablets

目的 :建立一种测定甲磺酸多沙唑嗪片剂的HLPC法 ,并用该方法测定甲磺酸多沙唑嗪片剂含量、含量均匀度和溶出度。方法 :色谱柱为DikmaC18(15 0mm× 4 6mm ,5 μm) ,流动相 :甲醇 -醋酸缓冲液 (5 2∶4 8,V/V) ;检测波长 2 5 0nm ;柱温 30℃。结果 :甲磺酸多沙唑嗪对照品溶液的线性方程为A =6 0 72 4c +1 94 1(n =7,r =1 0 0 0 ,线性范围 0 5～ 5 0mg·L-1) ,日内、日间RSD均 <2 % ,检测限为 2 5ng(rSN=3)。甲磺酸多沙唑嗪片剂含量在 10 1%～ 10 4 %之间 ,3批片剂 4 5min平均溶出度在 84 %～87%之间 ,含量均匀度A +1 8S <15。结论

AIM: To develop a HPLC to determine the content,uniformity and dissolution rate of doxazosin. METHODS: The HPLC separation was carried out on a Dikma C 18 (150 mm×4.6 mm,5 μm)column,using a UV detector and the wavelength was 250 nm , with methanol-acetic acid buffer (52∶48,V/V) as the mobile phase.The temperature of the column was 30 ℃. RESULTS: A good linearity was demonstrated by linear equation A=60.724c+1.941(n=7,r=1.000).The intra-day and inter-day deviation was showed by RSD<2%. The limit of detection of doxazosin was 2.5 ng.The content of doxazosin was between 101% and 104%,the A+1.8S was less than 15,the dissolution rate was between 84% and 87%. CONCLUSION: This method is validated to have a good linearity and it can be carried out conveniently to get reliable results.It can be used to determine the content of doxazosin.