HPLC法同时测定复方坎地沙坦酯氢氯噻嗪片中的主成分含量

Simultaneous Determination of Main Components in Compound Hydrochlorothiazide/Candesartan Cilexetil Tablets by HPLC

目的:建立同时测定复方坎地沙坦酯氢氯噻嗪片中主成分含量的方法。方法:采用高效液相色谱法。色谱柱为VenusilXBP-C18,以磷酸盐缓冲液(pH7.0)为水相、甲醇-乙腈(2∶1)混合液为有机相进行梯度洗脱,流速为1.0ml/min,柱温为40℃,检测波长为262nm。结果:氢氯噻嗪、坎地沙坦酯分离度均大于1.5,检测质量浓度线性范围分别为2.5～100.0、1.62～64.8mg/L(r均为0.9999),平均回收率分别为99.23%、99.78%,RSD分别为1.23%、0.84%(n=9)。结论:该方法对2种主成分分离效果较好,结果准确、可靠,适用于同时测定复方坎地沙坦酯氢氯噻嗪片剂中的2个主成分的含量。

OBJECTIVE： To estbalish the method for simultaneous determination of main components in Compound hydrochlorothiazide/candesartan cilexetil tablets. METHODS： HPLC method was adopted. The determination was performed on Venusil XBP-C18 column with phosphate buffer （pH 7.0） as water phase and methanol-acetonitrile （2 ∶ 1） as organic phase （gradient elution） at the flow rate of 1.0 ml/min. The column temperature was 40 ℃, and detection wavelength was set at 262 nm. RESULTS： The separation rates of hydrochlorothiazide and candesartan cilexetil were all more than 1.5. The linear ranges were 2.5-100.0 mg/L for hydrochlorothiazide and 1.62-64.8 mg/L for candesartan cilexetil （all r=0.999 9）. The mean recoveries were 99.23% （RSD=1.23%, n=9） and 99.78% （RSD=0.84%, n=9）, respectively. CONCLUSIONS： 2 kinds of main components are well-separated by this method. The method is accurate and reliable, and suitable for simultaneous determination of 2 kinds of main components in Compound hydrochlorothiazide/candesartan cilexetil tablets.