HPLC法测定复方氨氯地平缬沙坦氢氯噻嗪片剂溶出度

发布时间：2018-11-09 09:25

【摘要】：目的:优化并建立复方氨氯地平缬沙坦氢氯噻嗪片剂溶出度的测定方法,同时检测氨氯地平、缬沙坦和氢氯噻嗪3个组分的溶出度。方法:采用Zorbax SB-C18(3.0 mm×150 mm,5μm)色谱柱,以0.1%三乙胺(p H 2.8)-甲醇-乙腈为流动相进行梯度洗脱,流速0.8 m L·min-1,检测波长230 nm。结果:本方法系统适用性佳,3个组分分离度良好,空白辅料及强制降解产物不干扰3个组分的测定;氨氯地平、缬沙坦和氢氯噻嗪的线性范围分别为2.8~17.3μg·m L-1(r2=0.999 9)、32.0~200.2μg·m L-1(r2=0.999 4)和2.5~15.6μg·m L-1(r2=0.999 6);平均回收率(n=9)分别为100.6%(RSD=1.1%)、100.8%(RSD=0.62%)和101.0%(RSD=0.70%);定量限分别为0.33、0.13和0.12μg·m L-1;检测限分别为0.10、0.03和0.03μg·m L-1;供试品溶液在72 h内稳定;耐用性良好;该方法测得氨氯地平、缬沙坦和氢氯噻嗪在30 min溶出度分别为标示量的92%、94%和91%。结论:该方法适用于复方氨氯地平缬沙坦氢氯噻嗪片剂溶出度的检测。
[Abstract]:Aim: to optimize and establish a method for determination of dissolution of compound amlodipine valsartan hydrochlorothiazide tablets and to detect the dissolution of amlodipine valsartan and hydrochlorothiazide. Methods: Zorbax SB-C18 column (3.0 mm 脳 150 mm,5 渭 m) was used. The mobile phase consisted of 0.1% triethylamine (p H 2.8) -methanol-acetonitrile as the mobile phase. The flow rate was 0.8 mL / L min-1, detection wavelength was 230 nm.. Results: this method has good applicability, the separation degree of three components is good, the blank excipient and the forced degradation product do not interfere with the determination of the three components. The linear ranges of amlodipine, valsartan and hydrochlorothiazide were 2.8n 17.3 渭 g mL ~ (-1) (r _ 2o _ (0.999 9), 32.0 ~ 200.2 渭 g m ~ (-1) (r _ 2o _ (0.999 4) and 2.5 渭 g ~ (-1) 15.6 渭 g / m ~ (-1) (r _ (2o _ (0.999) 6), respectively). The average recoveries (nong9) were 100.6% (RSD=1.1%), 100.8% (RSD=0.62%) and 101.0% (RSD=0.70%), and the quantification limits were 0.33 渭 g / ml and 0.12 渭 g mL ~ (-1), respectively. The detection limits were 0.10 渭 g ml ~ (-1) and 0.03 渭 g mL ~ (-1), respectively. The dissolution of amlodipine, valsartan and hydrochlorothiazide at 30 min was 92% and 91%, respectively. Conclusion: this method is suitable for determination of dissolution of compound amlodipine valsartan hydrochlorothiazide tablets.
【作者单位】：中国药科大学药物分析教研室;南京金陵药业股份有限公司技术中心;
【分类号】：R927.2;O657.72

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