高效液相色谱法对坎地沙坦酯固体分散体颗粒溶出度的测定

摘要

Objective To establish HPLC method for the determination of Solid Dispersion Granules of CandesartanrnCilexetil. Methods Method Ⅱ of determination of dissolution in Chinese Pharmacopeia (2010 edition, Part Ⅱ), andrnHPLC was employed to detect the concentration with conditions that acetonitrile- water-acetic acid (57:43:1) as mobilernphase with flow rate of 1 mL/min, and detection wavelength of 254 nm. Results The linear range was 0.42-67.20 mg/Lrn(A = 29.436 3C+31.424 4, r = 0.999 8), the average recovery rate was 99.7% (RSD = 0.3%). Conclusion The methodrnis accurate and reliable, and can be used for determination of dissolution for Immediate-Release Granules, SustainedrnRelease Granules and Tablets of Candesartan Cilexetil.%目的 建立用于测定坎地沙坦酯固体分散体颗粒溶出度的高效液相测定方法.方法 采用<中国药典>2010年版二部溶出度测定法二法,以乙腈-水-冰醋酸(57∶43∶1)为流动相,流速为1 mL/min,检测波长为254 nm,测定溶出液的浓度.结果 所得溶液线性范围为0.42～67.20 mg/L(A ＝ 29.436 3C+31.424 4,r = 0.999 8),平均回收率99.7%(RSD = 0.3%).结论 本方法准确可靠,可用于坎地沙坦酯速释、缓释颗粒及片剂的溶出度测定.