Zhou Zhifeng, Ye Jufeng, Chen Lingyun, Ma Ande, Zou Fei
School of Public Health and Tropical Medicine, Southern Medical University, Guangzhou, Guangdong, China.
Yakugaku Zasshi. 2010 Aug;130(8):1061-8. doi: 10.1248/yakushi.130.1061.
A simple and rapid high-performance liquid chromatography method coupled with UV detector was developed and validated for the simultaneous determination of ropivacaine, bupivacaine and dexamethasone in biodegradable poly(lactic-co-glycolic acid) (PLGA) microspheres within 11 min. Chromatographic separation was performed on a XDB-C(18) column using a mobile phase comprised of acetonitrile-NaH(2)PO(4) buffer (pH 3.5, 30 mM) (30:70, v/v) with a flow rate gradient program. The method was in good linearity (r>0.999) over the range of 0.025-40.0 microg/ml for ropivacaine and bupivacaine, and 0.05-40 microg/ml for dexamethasone. The method was proved to be precise with intra- and inter-day precision less than 3.0% and 6.0% for all drugs and accurate with intra- and inter-day accuracy between -8.0% to 4.5% and between -5.0% to 5.5% for all drugs. The assay was rapid, simple and easy to apply. Therefore, it was very suitable for routine determination and quality control of ropivacaine, bupivacaine and dexamethasone in PLGA microspheres.
建立了一种简单快速的高效液相色谱法并结合紫外检测器,用于在11分钟内同时测定可生物降解的聚(乳酸-乙醇酸)(PLGA)微球中的罗哌卡因、布比卡因和地塞米松。色谱分离在XDB-C(18)柱上进行,使用由乙腈-NaH(2)PO(4)缓冲液(pH 3.5,30 mM)(30:70,v/v)组成的流动相,并采用流速梯度程序。该方法在罗哌卡因和布比卡因0.025 - 40.0 μg/ml、地塞米松0.05 - 40 μg/ml范围内具有良好的线性(r>0.999)。该方法被证明是精确的,所有药物的日内和日间精密度均小于3.0%和6.0%,所有药物的日内和日间准确度在-8.0%至4.5%之间以及-5.0%至5.5%之间。该测定方法快速、简单且易于应用。因此,它非常适合用于PLGA微球中罗哌卡因、布比卡因和地塞米松的常规测定和质量控制。