HPLC 测定复方地巴唑氢氯噻嗪胶囊中 8 种组分的含量

  目的 建立高效液相色谱法同时测定复方地巴唑氢氯噻嗪胶囊中氢氯噻嗪、维生素 B₆ 、维生素 B₁ 、硫酸胍生、地巴唑、氯氮、磷酸氯喹和盐酸异丙嗪等 8 种组分含量的方法。 方法 提取溶剂为甲醇 - 水 (50 ∶ 50) ，色谱柱为 Ultimate XB-C₁₈(4.6 mm × 150 mm ， 5 μm) ，流动相为甲醇 -5 mmol·L^-1 庚烷磺酸钠溶液 - 冰醋酸 (55 ∶ 45 ∶ 0.25), 检测波长为 284 nm 。 结果 线性范围分别为氢氯噻嗪 30.2~151.0 mg·L^-1 (<>r=0.999 8) ；维生素 B₆10.2 ～ 51.0 mg·L^-1 (<>r=1.000 0) ；维生素 B₁ 10.1~50.5 mg·L^-1 (<>r=0.999 9) ；硫酸胍生 12.1~60.5 mg·L^-1 (<>r=1.000 0) ；地巴唑 99.8~499.0 mg·L^-1 (<>r=0.999 2) ；氯氮 20.1~100.5 mg·L^-1 (<>r= 1.000 0) ；磷酸氯喹 24.88~124.4 mg·L^-1 (<>r=1.000 0) ；盐酸异丙嗪 30.3~151.5 mg·L^-1 (<>r=1.000 0) 。平均回收率 (<>n=9) 分别为氢氯噻嗪 101.2%(RSD=1.4%) ，维生素 B₆102.2%(RSD=0.9%) ，维生素 B₁100.5% (RSD=1.5%) ，硫酸胍生 101.6%(RSD=1.5%) ，地巴唑 101.8% (RSD=1.1%) ，氯氮 99.3% (RSD= 1.3%) ，磷酸氯喹 101.5%(RSD=1.6%) ，盐酸异丙嗪 101.7 % (RSD=1.7%) 。 结论 本法简便快速，准确可靠，适于该复方制剂中 8 种组分的同时测定。

Determination of Eight Components in Compound Dibazol and Hydrochlorothiazide Capsules by HPLC

OBJECTIVE To establish a HPLC method for the simultaneous determination of eight components in compound dibazol and hydrochlorothiazide capsules: hydrochlorothiazide，vitamin B6，vitamin B1，guanoxan sulfate，dibazol，chlordiazepoxide ，chloroquine phosphate and promethazine hydrochloride. METHODS The methanol-water（50∶50） was used as extraction solvent.The chromatographic analysis was carried out on a Ultimate XB-C18 column (4.6 mm×150 mm，5 μm) . The mobile phase consisted of methanol -5 mmol·L-1 sodium heptanesulfonate solution-acetic acid glacial (55∶45∶0.25). The detection wavelength was at 284 nm. RESULTS The linear response ranges were: 30.2-151.0 mg·L-1 for hydrochlorothiazide (r=0.999 8)，10.2-51.0 mg·L-1 for vitamin B6 (r=1.000 0)，10.1-50.5 mg·L-1 for vitamin B1 (r=0.999 9)， 12.1-60.5 mg·L-1 for guanoxan sulfate (r=1.000 0)，99.8-499.0 mg·L-1 for dibazol (r=0.999 2)， 20.1-100.5 mg·L-1 for chlordiazepoxide (r=1.000 0)， 24.88-124.4 mg·L-1 for chloroquine phosphate (r=1.000 0)，30.3-151.5 mg·L-1 for promethazine hydrochloride (r=1.000 0) respectively. The mean recoveries(n=9) were 101.2% (RSD=1.4%) for hydrochlorothiazide，102.2% (RSD=1.2%) for vitamin B6，100.5% (RSD=1.5%) for vitamin B1，101.6%(RSD=1.5%) for guanoxan sulfate，101.8% (RSD=1.1%) for dibazol， 99.3%(RSD=1.3%) for chlordiazepoxide，101.5%(RSD=1.6%) for chloroquine phosphate，101.7% (RSD=1.7%) for promethazine hydrochloride respectively. CONCLUSION A satisfactory separation of eight components was obtained. This method is simple，quick, precise and accurate. This method is suitable for the determination of the eight components in compound dibazol and hydrochlorothiazide capsules.