CAJ | 학술논문

目的：改进盐酸哌唑嗪片现行质量标准，使检测结果更准确，操作更环保。方法：建立反相高效液相色谱法测定盐酸哌唑嗪片的含量、含量均匀度和有关物质。采用Waters Sunfire C18柱（4.6 mm×250 mm，5μm），流动相为甲醇-磷酸盐缓冲液（磷酸二氢钾1.36 g，加水溶解并稀释制成1000 mL，加三乙胺4 mL，用磷酸调节pH值至4.5）（40∶60），流速：1 mL·min-1，检测波长：245 nm，柱温：35℃，进样体积：10μL。结果：盐酸哌唑嗪在4.910～49.10μg·mL-1范围内线性关系良好（r=1.000， n=6）；平均回收率为99.50％，RSD=0.70％。结论：本方法经方法学验证，可用于盐酸哌唑嗪片含量、含量均匀度测定和有关物质检查。
목적：개진염산고서진편현행질량표준，사검측결과경준학，조작경배보。방법：건립반상고효액상색보법측정염산고서진편적함량、함량균균도화유관물질。채용Waters Sunfire C18주（4.6 mm×250 mm，5μm），류동상위갑순-린산염완충액（린산이경갑1.36 g，가수용해병희석제성1000 mL，가삼을알4 mL，용린산조절pH치지4.5）（40∶60），류속：1 mL·min-1，검측파장：245 nm，주온：35℃，진양체적：10μL。결과：염산고서진재4.910～49.10μg·mL-1범위내선성관계량호（r=1.000， n=6）；평균회수솔위99.50％，RSD=0.70％。결론：본방법경방법학험증，가용우염산고서진편함량、함량균균도측정화유관물질검사。
Objective:To improve the present quality standard of Prazosin Hydrochloride Tablets, and to increase the accuracy of the test results and the environmental friendliness of the operation.Methods:A reverse-phase HPLC method was established for the determination of the contents, content uniformity and related substances in Prazosin Hydrochloride Tablets. The Waters Sunifre C18 column(4.6 mm×250 mm, 5 μm)was adopted with the mobile phase of methanol-phosphate buffer solution(containing 0.1 mol·L-1 potassium dihydrogen phosphate and 0.4% triethylamine, adjusted to pH 4.5 with phosphoric acid) (40∶60). The flow rate was 1 mL·min-1, and the detection wavelength was 245 nm. The column temperature was 35℃, and the volume of injection was 10 μL.Results:The linear range of Prazosin Hydrochloride was 4.910-49.10 μg?mL-1(r=1.000, n=6). The average recovery rate was 99.50%, RSD=0.70%.Conclusion:Veriifed by methodology, the method could be applied to determine the content, content uniformity and related substances in Prazosin Hydrochloride Tablets.