论文部分内容阅读
目的:建立同时测定复方罗布麻片Ⅰ中氢氯噻嗪和盐酸异丙嗪含量及含量均匀度的高效液相色谱方法。方法:采用高效液相色谱-紫外波长切换法。色谱柱为YMC-Pack Pro C18(250 mm×4.6 mm,5μm),流动相为0.06 mol·L-1磷酸二氢钾溶液(用磷酸调节pH为3.0)-甲醇,进行梯度洗脱,流速:1.0 ml·min-1,柱温:35℃,检测波长:271 nm(0~13 min),251nm(13~25 min),进样量:含量项下10μl,含量均匀度项下20μl。结果:氢氯噻嗪和盐酸异丙嗪的线性范围分别为0.255 9~2.558 9μg(r=0.999 9)和0.175 1~1.751 4μg(r=0.999 9);平均加样回收率分别为98.06%(RSD=0.64%,n=9)和99.61%(RSD=0.53%,n=9)。结论:该分析方法简便、快速、准确、重复性好,为更好地控制复方罗布麻片Ⅰ的内在质量提供科学的依据。
OBJECTIVE: To establish a HPLC method for the simultaneous determination of hydrochlorothiazide and promethazine hydrochloride in Compound Apocynum Tablets Ⅰ. Methods: High performance liquid chromatography - UV wavelength switching method. The column was YMC-Pack Pro C18 (250 mm × 4.6 mm, 5 μm) and the mobile phase consisted of 0.06 mol·L-1 potassium dihydrogen phosphate solution (adjusted to pH 3.0 with phosphoric acid) 1.0 ml · min-1, column temperature: 35 ℃, detection wavelength: 271 nm (0-13 min), 251 nm (13-25 min). Injection volume: 10μl content, content uniformity 20μl. Results: The linear ranges of hydrochlorothiazide and promethazine hydrochloride were 0.255 9 ~ 2.558 9μg (r = 0.999 9) and 0.175 1 ~ 1.751 4μg (r = 0.999 9) respectively. The average recoveries were 98.06% (RSD = 0.64 %, n = 9) and 99.61% (RSD = 0.53%, n = 9). Conclusion: The method is simple, rapid, accurate and reproducible. It provides a scientific basis for better control of the intrinsic quality of compound Apocynum.