Shamim Athar, Ansari Mohammad Javed, Aodah Alhussain, Iqbal Muzaffar, Aqil Mohd, Mirza Mohd Aamir, Iqbal Zeenat, Ali Asgar
Department of Pharmaceutics, School of Pharmaceutical Education and Research, Jamia Hamdard, New Delhi 110062, India.
Department of Pharmaceutics, College of Pharmacy, Prince Sattam Bin Abdulaziz University, Al-Kharj 11942, Saudi Arabia.
ACS Omega. 2023 Jun 8;8(24):21618-21627. doi: 10.1021/acsomega.3c00956. eCollection 2023 Jun 20.
In the given study, a new reverse-phase high-performance liquid chromatography (RP-HPLC) method has been reported for the simultaneous estimation of ciprofloxacin hydrochloride (CPX) and rutin (RUT) using quality by design (QbD) approach. The analysis was carried out by applying the Box-Behnken design having fewer design points and less experimental runs. It relates between factors and responses and gives statistically significant values, along with enhancing the quality of the analysis. CPX and RUT were separated on the Kromasil C column (4.6 × 150 mm, 5 μm) using an isocratic mobile phase combination of phosphoric acid buffer (pH 3.0) and acetonitrile with the ratio of 87:13% v/v at a flow rate of 1.0 mL/min. CPX and RUT were detected at their respective wavelengths of 278 and 368 nm using a photodiode array detector. The developed method was validated according to guideline ICH Q2 R (1). The validation parameters taken were linearity, system suitability, accuracy, precision, robustness, sensitivity, and solution stability which were in the acceptable range. The findings suggest that the developed RP-HPLC method can be successfully applied to analyze novel CPX-RUT-loaded bilosomal nanoformulation prepared by thin-film hydration technique.
在给定的研究中，已经报道了一种新的反相高效液相色谱（RP-HPLC）方法，该方法采用质量源于设计（QbD）方法同时测定盐酸环丙沙星（CPX）和芦丁（RUT）。分析通过应用设计点较少且实验运行次数较少的Box-Behnken设计进行。它关联了因素和响应，并给出具有统计学意义的值，同时提高了分析质量。CPX和RUT在Kromasil C柱（4.6×150 mm，5μm）上分离，使用磷酸缓冲液（pH 3.0）和乙腈的等度流动相组合，比例为87:13% v/v，流速为1.0 mL/min。使用光电二极管阵列检测器在CPX和RUT各自的波长278和368 nm处进行检测。所开发的方法根据ICH Q2 R（1）指南进行了验证。所采用的验证参数包括线性、系统适用性、准确度、精密度、稳健性、灵敏度和溶液稳定性，这些参数均在可接受范围内。研究结果表明，所开发的RP-HPLC方法可成功应用于分析通过薄膜水化技术制备的新型载CPX-RUT双分子层纳米制剂。
