CAJ | 학술논문

目的：建立测定三种制剂（水杨酸软膏、水杨酸硫软膏、复方硫软膏）中水杨酸含量的方法。方法：采用HPLC法，色谱柱：Diamonsil C18（250 mm ×4.6 mm，5μm）；流动相：甲醇-0.1 mol·L-1磷酸二氢钠（30：70）；检测波长：231 nm；流速：1.0 mL·min-1；柱温：35℃；进样量：10μL。结果：水杨酸与其它杂质峰分离良好，水杨酸在12.32~123.20μg·mL-1范围内与峰面积呈良好的线性关系（r =1.0000）；水杨酸在水杨酸软膏、水杨酸硫软膏、复方硫软膏的平均回收率分别为100.55%、99.96%、99.13%，RSD分别为0.95%（n=9）、0.96%（n=9）、1.15%（n=9）。结论：采用该方法测定三种制剂中的水杨酸含量，简便易行，结果准确，可作为三种制剂中水杨酸的质量控制方法。
목적：건립측정삼충제제（수양산연고、수양산류연고、복방류연고）중수양산함량적방법。방법：채용HPLC법，색보주：Diamonsil C18（250 mm ×4.6 mm，5μm）；류동상：갑순-0.1 mol·L-1린산이경납（30：70）；검측파장：231 nm；류속：1.0 mL·min-1；주온：35℃；진양량：10μL。결과：수양산여기타잡질봉분리량호，수양산재12.32~123.20μg·mL-1범위내여봉면적정량호적선성관계（r =1.0000）；수양산재수양산연고、수양산류연고、복방류연고적평균회수솔분별위100.55%、99.96%、99.13%，RSD분별위0.95%（n=9）、0.96%（n=9）、1.15%（n=9）。결론：채용해방법측정삼충제제중적수양산함량，간편역행，결과준학，가작위삼충제제중수양산적질량공제방법。
Objective:To establish the HPLC method for determining the content of salicylic acid in three preparations (salicylic acid ointment, salicylic acid and sulfur ointment, compound sulfur sublimate ointment). Methods:HPLC analysis was carried out with Diamonsil C18 column (250 mm × 4.6 mm, 5 μm), the mobile phase consisted of methanol-0.1 mol·L-1 sodium dihydrophosphate solution (30 : 70), the detection wavelength was set at 231 nm, the flow rate was 1.0 mL·min-1, the column temperature was 35℃and the sample size was 10μL. Results: The sample was separated well from impurities by this HPLC method. The calibration curve of salicylic acid was linear in the range of 12.32-123.20μg·mL-1 (r=1.000 0). The average recoveries and the RSD of salicylic acid were 100.55%and 0.95%(n=9) in the salicylic acid ointment, 99.96%and 0.96%(n=9) in the salicylic acid and sulfur ointment, 99.13%and 1.15%(n=9) in sulfur sublimate ointment, respectively. Conclusion:This method is accurate and feasible, which can be applied as the quantitative method for the determination of salicylic acid in three preparations.