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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(4.6mm×150mm,5μm),流动相为甲醇-5mmol·L-1庚烷磺酸钠溶液-冰醋酸(55∶45∶0.25),检测波长为284nm。结果线性范围分别为氢氯噻嗪30.2~151.0mg·L-1(r=0.9998);维生素B610.2～51.0mg·L-1(r=1.0000);维生素B110.1~50.5mg·L-1(r=0.9999);硫酸胍生12.1~60.5mg·L-1(r=1.0000);地巴唑99.8~499.0mg·L-1(r=0.9992);氯氮20.1~100.5mg·L-1(r=1.0000);磷酸氯喹24.88~124.4mg·L-1(r=1.0000);盐酸异丙嗪30.3~151.5mg·L-1(r=1.0000)。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。
OBJECTIVE To establish a method for the simultaneous determination of 8 components in hydrochlorothiazide, vitamin B6, vitamin B1, guanidinium sulfate, dicarbazole, clozapine, chloroquine phosphate and promethazine hydrochloride in compound methimazole hydrochlorothiazide by HPLC . Methods The extraction solvent was methanol-water (50:50). The column was Ultimate XB-C18 (4.6 mm × 150 mm, 5 μm). The mobile phase was methanol-5 mmol·L -1 sodium heptanesulfonate solution-glacial acetic acid : 45: 0.25), the detection wavelength is 284nm. The linear range of the results was 30.2-151.0 mg · L-1 for hydrochlorothiazide (r = 0.9998), vitamin B 610.2-51.0 mg · L-1 (r = 1.0000), vitamin B110.1-50.5 mg · L-1 = 0.9999); guanidine sulfate was 12.1 ~ 60.5 mg · L-1 (r = 1.0000), and methimazole was 99.8 ~ 499.0 mg · L-1 = 1.0000); chloroquine phosphate 24.88 to 124.4 mg · L -1 (r = 1.0000); promethazine hydrochloride 30.3 to 151.5 mg · L -1 (r = 1.0000). The mean recoveries (n = 9) were 101.2% for hydrochlorothiazide (RSD = 1.4%), 102.22% for vitamin B (RSD = 0.9%), 100.5% for vitamin B (RSD = 1.5% (RSD = 1.5%), methimazole 101.8% (RSD = 1.1%), chloro-nitrogen 99.3% (RSD = 1.3%), chloroquine 101.5% %). Conclusion The method is simple, rapid, accurate and reliable and suitable for the simultaneous determination of eight components in the compound preparation.