Determination of Morphine Sulfate Sustained Release Suppositories by HPLC / 中国药师

ABSTRACT

Objective:To prepare morphine sulfate sustained-release suppositories and determine the content by HPLC. Methods:An Eclipse XDB-C18 (150 mm × 4. 6 mm,5 μm) chromatographic column was used, methanol-heptane sulfonic acid sodium acetate solu-tion(2. 02 g sodium heptanesulfonate was dissolved in appropriate amount of water and 5ml glacial acetic acid was added, and then water was added to 1000 ml, shaken up) (50 ∶50) was used as the mobile phase, the flow rate was 1. 0 ml·min-1 , the detection wavelength was 233 nm, the column temperature was 25℃ and the sample size was 10μl. Results:The average content of morphine in 3 batches of samples was 99. 9%, the linear range of 4. 18-86. 60μg·ml-1 was good (r=0. 999 3), and the average recovery was 100. 6% (RSD=1. 58%, n=9). Conclusion:The method is sensitive, rapid and accurate, and suitable for the quality control of morphine sulfate sus-tained-release suppositories.