HPLC双波长法测定复方罗布麻片Ⅰ中泛酸钙和氢氯噻嗪的含量

Determination of Calcium Pantothenate and Hydrochlorothiazide in Compound Kendir Leaves Tablet Ⅰ by Dual Wavelengths of HPLC

关键词:  复方罗布麻片Ⅰ  泛酸钙  氢氯噻嗪  高效液相色谱法

Key words:  Compound Kendir Leaves tablet I  calcium pantothenate  hydrochlorothiazide  HPLC

摘要:

目的 建立HPLC双波长法测定复方罗布麻片Ⅰ中泛酸钙和氢氯噻嗪的含量。方法 采用Kromasil C₁₈色谱柱（250 mm×4.6 mm，5 μm），以含0.1%辛烷磺酸钠溶液（用磷酸调节pH值至3.0）-乙腈（96：4）为流动相A，以甲醇为流动相B，采用梯度洗脱，柱温为35℃，检测波长泛酸钙200 nm、氢氯噻嗪275 nm，流速为1.0 mL·min^-1，进样量为10 μL。结果 泛酸钙和氢氯噻嗪分别在0.025~0.5 μg（r=0.999 6）和0.16~3.2 μg（r=1.000 0）内线性关系良好；平均加样回收率（n=9）分别为101.2%（RSD=0.47%）和101.6%（RSD=0.49%）。结论 本法精密度好，结果准确可靠，适用于该制剂的质量检验分析。

Abstract:

OBJECTIVE To establish a dual wavelengths of HPLC method for the determination of calcium pantothenate and hydrochlorothiazide in Compound Kendir Leaves tablet Ⅰ. METHODS The Kromasil C₁₈ (250 mm×4.6 mm, 5 μm) was used with the mobile phase A[0.1% octane sulfonic acid sodium (adjust pH to 3.0 with phosphoric acid)-acetonitrile (964)]-methanol as mobile phase B with gradient elution. The column temperature was set as 35℃ and the detection wavelength was set at 200 nm for calcium pantothenate and 275 nm for hydrochlorothiazide. The flow rate was 1.0 mL·min^-1 and the injection volume was 10 μL. RESULTS The linear range was good within 0.025-0.5 μg (r=0.999 6) for calcium pantothenate, 0.16-3.2 μg(r=1.000 0) for hydrochlorothiazide, respectively. The average recoveries(n=9) were 101.2% (RSD=0.47%) and 101.6% (RSD=0.49%), respectively. CONCLUSION The method is accurate and reliable for the quality control of this compound preparation.