Pramar Y, Das Gupta V, Bethea C, Zerai T
Department of Pharmaceutics, University of Houston, TX 77030.
J Clin Pharm Ther. 1991 Oct;16(5):341-4. doi: 10.1111/j.1365-2710.1991.tb00323.x.
Cefuroxime axetil is a mixture of two equally active isomers (50% each). A stability-indicating high-pressure liquid chromatography method for the quantification of cefuroxime axetil has been developed. The method is accurate, precise and reproducible. The percentage, relative standard deviation based on six injections was 1.2. Using the developed method, the chemical stability of cefuroxime axetil suspensions has been determined in three vehicles containing sugar and two without sugar. The results varied widely in the vehicles without sugar (up to +/- 31%). In the viscous vehicles containing sugar, the variations in the results were only up to +/- 6%. The cefuroxime axetil in these suspensions was stable up to 28 days when stored at 5 degrees C. In addition, pH values were stable and the physical appearances of the samples did not change.
头孢呋辛酯是两种活性相当的异构体(各占50%)的混合物。已开发出一种用于定量头孢呋辛酯的稳定性指示高压液相色谱法。该方法准确、精密且可重现。基于六次进样的相对标准偏差百分比为1.2。使用所开发的方法,已在三种含糖载体和两种无糖载体中测定了头孢呋辛酯混悬液的化学稳定性。在无糖载体中结果差异很大(高达±31%)。在含糖的粘性载体中,结果的变化仅高达±6%。这些混悬液中的头孢呋辛酯在5℃储存时长达28天是稳定的。此外,pH值稳定,样品的外观没有变化。