RP-HPLC-FLD法测定盐酸氟桂利嗪片中盐酸氟桂利嗪的含量及含量均匀度

目的 RP-HPLC-FLD法测定盐酸氟桂利嗪片中盐酸氟桂利嗪的含量及含量均匀度.方法 采用DiamonsilTM C18柱（250mm×4.6mm,5μm）,以甲醇：0.02mol·L-1磷酸二氢铵（0.1%三乙胺,磷酸调pH至3.0）（70：30）为流动相,流速为1mL·min-1,激发波长260nm,发射波长310nm,柱温为25℃,进样体积10μL.结果 盐酸氟桂利嗪在6.1～122ng（r=0.9992）范围内呈良好的线性关系;平均回收率为100.07%（RSD=1.38%）;LOD和LOQ分别为2.44ng、8.13ng;3批样品的含量均匀度：A＋1.8S分别为5.644、4.194、7.160,均小于15.结论 该方法快速、准确,无内源物质干扰,可为盐酸氟桂利嗪片的质量标准的建立与完善提供科学依据,并指导临床合理用药.

Determination of content and content uniformity of Flunarizine Hydrochloride in Flunarizine Hydrochloride Tablets by RP-HPLC-FLD

OBJECTIVE To develop a method to determinate the content and content unifromity of Flunarizine Hydrochloride in Flunarizine Hydrochloride Tablets by RP-HPLC FLD. METHODS DiamonsilTM C18 column （250mm ×4. 6mm,5μm） was used with methanol and 0. 02 mol·L-1 ammonium dihydrogen phosphate（0. 1% triethylamine ,adjust pH to 3.0 by phosphoric acid） （70：30） as mobile phase. The flow rate was 1mL · min-1 ,excitation wavelength was 260nm, the emission wavelength was 310nm, the column temperature was 25℃ with sample vol- ume for 10μL. RESULTS Flunarizine Hydrochloride had good linear relationship for 6. 1 - 122ng （r =0. 9992） ; The average recovery was 100. 07% （ RSD = 1.38% ） ;The LOD and LOQ were 2.44ng,8. 13ng,respectively;content uniformity of three batch sample： A ＋ 1.8S were 5.644, 4. 194, 7. 160, respectively, less than 15. CONCLUSION This method is rapid and accurate,without interference from internal components of Flunarizine Hydrochloride Tablets, which provides a scientific basis for the establishment and perfection of quality standards, and guides clinical rational drug use.