Chen Yi-Cheng, Tsai Pi-Ju, Huang Yaw-Bin, Wu Pao-Chu
School of Pharmacy, College of Pharmacy, Kaohsiung Medical University, Kaohsiung, Taiwan, Republic of China.
Department of Business Administration, I-Shou University, Kaohsiung, Taiwan, Republic of China.
PLoS One. 2015 Mar 20;10(3):e0120171. doi: 10.1371/journal.pone.0120171. eCollection 2015.
The aim of this study was to develop a simple and reliable high-performance chromatographic (HPLC) method for simultaneous analysis of adapalene and benzoyl peroxide in pharmaceutical formulation by response surface methodology (RSM). An optimized mobile phase composed of acetonitrile, tetrahydrofuran and water containing 0.1% acetic acid at a ratio of 25:50:25 by volume was successfully predicted by using RSM. An isocratic separation was achieved by using the condition. Furthermore, the analytical method was validated in terms of specificity, linearity, accuracy and precision in a range of 80% to 120% of the expected concentration. Finally, the method was successfully applied to the analysis of a commercial product.
本研究的目的是通过响应面法（RSM）开发一种简单可靠的高效液相色谱（HPLC）方法，用于同时分析药物制剂中的阿达帕林和过氧化苯甲酰。通过RSM成功预测了一种优化的流动相，其由体积比为25:50:25的乙腈、四氢呋喃和含0.1%乙酸的水组成。采用该条件实现了等度分离。此外，该分析方法在预期浓度的80%至120%范围内进行了特异性、线性、准确度和精密度方面的验证。最后，该方法成功应用于一种商业产品的分析。
