HPLC法同时测定复方罗布麻片Ⅰ中氢氯噻嗪和盐酸异丙嗪的含量及含量均匀度

Simultaneous Determination of Content and Uniformity of Hydrochlorothiazide and Promethazine Hydrochloride in Compound Kendir Leaves Tablets Ⅰ by HPLC

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 method for the simultaneous determination of content and uniformity of hydrochlorothiazide and promethazine hydrochloride in compound kendir leaves tablets I. Methods：An HPLC-UV wavelength switching method was adopted. The separation was carried out on a YMC-Pack Pro-C18（250 mm × 4. 6 mm,5 μm）column with 0. 06 mol·L-1 potassium phosphate monobasic solution（adjusting pH to 3. 0 with phosphoric acid ）-methanol as the mobile phase with gradient elution. The flow rate was 1. 0 ml·min-1 , the column temperature was set at 35℃. During 0 to13 min, the detection wavelength was 271 nm, and during 13 to 25 min, the detection wavelength was 251nm. The injection volume was 10μl for content determination and 20μl for content uniformity. Results：The linear range of hydrochlorothiazide and promethazine hydrochloride was 0. 255 9 -2. 558 9 μg （r=0. 999 9） and 0. 175 1-1. 751 4 μg （r=0. 999 9） with the average recovery of 98. 06%（RSD=0. 64%, n=9）and 99. 61%（RSD=0. 53%, n=9）, respectively. Conclusion：The method is simple, rapid, accurate and reproducible, which can provide a scientific basis for the quality control of compound kendir leaves tablets I.