Simultaneous Determination of Content and Uniformity of Hydrochlorothiazide and Promethazine Hydro-chloride in Compound Kendir Leaves Tablets Ⅰ by HPLC / 中国药师

ABSTRACT

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 adopt-ed. 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 phos-phate 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 uni-formity. 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.