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目的:建立复方硫酸双肼曲嗪的含量均匀度方法,评价药品质量。方法:采用Aglient Eclipse XDB-CN柱(250 mm×4.6 mm,5μm),流动相为乙腈-0.01 mol·L-1庚烷磺酸钠溶液(用20%磷酸调节pH至2.7)(55∶45),流速为0.8 mL·min-1,检测波长316 nm。结果:硫酸双肼屈嗪在34.38～343.8 mg·L-1的范围内线性关系良好(r=0.9999,n=6),测得平均回收率为100.1%(RSD=0.70%);氢氯噻嗪在25.70～257.0 mg·L-1的范围内线性关系良好(r=0.9999,n=6),测得平均回收率为100.9%(RSD=0.33%)。结论:本方法简便、快速,专属性强,可用于复方硫酸双肼屈嗪片的质量控制。
Objective: To establish a method for the content uniformity of compound dihydrazide sulfate triazine to evaluate the quality of medicines. METHODS: Aglient Eclipse XDB-CN column (250 mm × 4.6 mm, 5 μm) was used. The mobile phase was acetonitrile-0.01 mol·L -1 sodium heptane sulfonate solution (adjusted to pH 2.7 with 20% phosphoric acid) ), Flow rate of 0.8 mL · min-1, detection wavelength of 316 nm. The results showed that the average recovery was 100.1% (RSD = 0.70%), and the linear range was from 34.38 to 343.8 mg · L-1 (r = 0.9999, n = 6) The average recovery was 100.9% (RSD = 0.33%) with a good linearity (r = 0.9999, n = 6) over the range of ~ 257.0 mg · L -1. Conclusion: The method is simple, rapid and specific, and can be used for the quality control of compound dihydralazine sulfate tablets.