Establishment of Determination Method for Drug Release of Phencynonate Hydrochloride Extended Release Tablets / 中国药师

ABSTRACT

Objective:To establish the drug release determination conditions and method for phencynonate hydrochloride extended release tablets. Methods:The drug release of the tablets was determined by HPLC using a Diamonsil C18 (250 mm × 4. 6 mm, 5 μm) column with the mobile phase of acetonitrile-water-phosphoric acid-triethylamine (270∶400∶1. 3∶2), the detection wavelength was 220 nm, the flow rate was 1. 0 ml·min-1 , the column temperature was 30 ℃ and the injection volume was 20 μl. The effects of different release apparatus, release media and rotation speeds on the release of phencynonate hydrochloride extended-release tablets were studied as well. Results:The established drug release determination method had a good linear relationship within the range of 0. 3-5. 0 μg· ml-1(r=0. 999 8), and the average recovery was 100. 6%(RSD=1. 16%, n=15). Under the conditions of 900ml pH 3. 0 phos-phate buffer solution as the release medium, rotation speed of 50 r·min-1 and the settlement basket as the apparatus, the release be-havior of the product was complied with a zero-level model in vitro, and the release equation was as followsQ=6. 141 2t-9. 328 7(r=0. 996). Conclusion:The method is simple, accurate and reliable, and suitable for the quality control of phencynonate hydrochlo-ride extended-release tablets.