高效液相色谱双波长法测定复方罗布麻片Ⅰ中6个组分的含量

目的：建立HPLC法同时测定复方罗布麻片Ⅰ中泛酸钙、氢氯噻嗪、维生素B₆、维生素B₁、硫酸双肼屈嗪及盐酸异丙嗪的含量。方法：采用Kromasil C₁₈色谱柱（250 mm×4.6 mm，5 μm）；流动相A为0.10%辛烷磺酸钠+0.40%磷酸二氢钾（磷酸调pH至3.0）-乙腈（96∶4），流动相B为乙腈，梯度洗脱；流速1.0 mL·min^-1；检测波长：泛酸钙200 nm，氢氯噻嗪、维生素B₆、硫酸双肼屈嗪、维生素B₁及盐酸异丙嗪均为271 nm；柱温30℃；进样量40 μL。结果：泛酸钙、氢氯噻嗪、维生素B₆、维生素B₁、硫酸双肼屈嗪及盐酸异丙嗪的线性范围分别为1.335~13.35 μg·mL^-1（r=0.999 9）、7.827~78.27 μg·mL^-1（r=1.000 0）、2.546~25.46 μg·mL^-1（r=1.000）、2.522~25.22 μg·mL^-1（r=0.999 9）、8.229~82.29 μg·mL^-1（r=0.997 6）和5.264~52.64 μg· mL-1（r=1.000）；平均回收率（RSD）分别为100.9%（1.1%）、101.6%（0.60%）、100.5%（0.87%）、100.0%（1.1%）、100.3%（0.99%）和100.4%（0.75%）；测定样品3批，上述6个成分的测定结果分别为标示量的98.38%~110.97%、101.08%~102.56%、96.58%~100.98%、100.50%~106.41%、41.48%~55.75%和88.88%~92.33%。结论：本法经方法学验证，可用于复方罗布麻片Ⅰ的质量控制。

Objective: To establish an HPLC method for simultaneous determination of calcium pantothenate, hydrochlorothiazide, pyridoxine hydrochloride, thiamine hydrochloride, sulfhydrazine sulfate and promethazine hydrochloride in the compound kendir leaf tabletsⅠ.Method: A Kromasil C₁₈ column (250 mm×4.6 mm, 5 μm)was adopted in the study.The mobile phase A consisted of 0.10% octane sulfonic acid sodium and 0.40% potassium dihydrogen phosphate (adjust pH to 3.0 with phosphoric acid)-acetonitrile (96:4).The mobile phase B was acetonitrile with gradient elution at a flow rate of 1.0 mL·min^-1.Dual detection wavelength was applied.Calcium pantothenate was 200 nm;hydrochlorothiazide、pyridoxine hydrochloride、thiamine hydrochloride、dihydralazine sulfateand and promethazine hydrochloride was 271 nm.The column temperature was controlled at 30℃ and the injection volume was 40 μL.Results: The linear ranges of calcium pantothenate, hydrochlorothiazide, pyridoxine hydrochloride, thiamine hydrochloride, sulfhydrazine sulfate and promethazine hydrochloride were 1.335-13.35 μg·mL^-1 (r=0.999 9), 7.827-78.27 μg·mL^-1 (r=1.000), 2.546-25.46 μg·mL^-1 (r=1.000), 2.522-25.22 μg·mL^-1 (r=0.999 9), 8.229-82.29 μg·mL^-1 (r=0.997 6) and 5.264-52.64 μg·mL^-1 (r=1.000) respectively.The average recovery ranges of six components were 100.9% (RSD=1.1%), 101.6% (0.60%), 100.5% (0.87%), 100.0% (1.1%), 100.3% (0.99%) and 100.4% (0.75%).Three batches of samples were determined.Six components of the measurement results were measured:98.38%-110.97%, 101.08%-102.56%, 96.58%-100.98%, 100.50%-106.41%, 41.48%-55.75% and 88.88%-92.33%, respectively.Conclusions: This method is verified by methodology and it can be used for quality control of the compound kendir leaf tablets I.