Rathee Anjali, Solanki Pavitra, Verma Surajpal, Vohora Divya, Ansari Mohammad Javed, Aodah Alhussain, Kohli Kanchan, Sultana Yasmin
Department of Pharmaceutics, School of Pharmaceutical Education and Research, Jamia Hamdard, New Delhi 110062, India.
Department of Pharmaceutics, Delhi Pharmaceutical Sciences and Research University, Pushp Vihar, Sec-III, New Delhi 110017, India.
ACS Omega. 2023 Aug 11;8(33):30057-30067. doi: 10.1021/acsomega.3c02097. eCollection 2023 Aug 22.
The present study involves the development of a reverse-phase HPLC method employing the quality-by-design methodology for the estimation of posaconazole and hemp seed oil simultaneously in nanomicelles formulation. The successful separation of posaconazole and hemp seed oil was achieved together, and this is the first study to develop and quantify posaconazole and hemp seed oil nanomicelles with linoleic acid as the internal standard and developed a dual drug analytical method employing a quality-by-design approach. The study was performed on a Shimadzu Prominence-I LC-2030C 3D Plus HPLC system with a PDA detector and the Shim-pack Solar C8 column (250 mm × 4.6 mm × 5 μm) for analysis with a mobile phase ratio of methanol:water (80:20% v/v) maintaining the flow rate of 1.0 mL/min. The final wavelength was selected as 240 nm and the elution of hemp seed oil and posaconazole was obtained at 2.7 and 4.6 min, respectively, with a maximum run time of 8.0 min. Box Behnken design was employed to optimize the method, keeping the retention time, peak area, and theoretical plates as dependent variables, while the mobile phase composition, flow rate, and wavelengths were chosen as independent variables. Parameters such as specificity, accuracy, robustness, linearity, sensitivity, precision, ruggedness, and forced degradation study were performed to validate the method. The calibration curves of posaconazole and hemp seed oil were determined to be linear throughout the range for concentration. The suggested approach can be effectively utilized for estimating the content of drugs from their nanoformulation and proved suitable for both and research.
本研究涉及开发一种采用质量源于设计方法的反相高效液相色谱法，用于同时测定纳米胶束制剂中的泊沙康唑和大麻籽油。成功实现了泊沙康唑和大麻籽油的同时分离，这是第一项以亚油酸为内标物开发并定量泊沙康唑和大麻籽油纳米胶束，并采用质量源于设计方法开发双药分析方法的研究。该研究在配备光电二极管阵列检测器的岛津Prominence - I LC - 2030C 3D Plus高效液相色谱系统上进行，使用Shim - pack Solar C8柱（250 mm×4.6 mm×5μm）进行分析，流动相比例为甲醇:水（80:20% v/v），保持流速为1.0 mL/min。最终波长选择为240 nm，大麻籽油和泊沙康唑的洗脱时间分别为2.7分钟和4.6分钟，最大运行时间为8.0分钟。采用Box - Behnken设计优化方法，将保留时间、峰面积和理论塔板数作为因变量，同时选择流动相组成、流速和波长作为自变量。进行了特异性、准确性、稳健性、线性、灵敏度、精密度、耐用性和强制降解研究等参数来验证该方法。泊沙康唑和大麻籽油的校准曲线在整个浓度范围内均呈线性。所建议的方法可有效用于从其纳米制剂中估计药物含量，并证明适用于 和 研究。 （注：原文中“both and research”部分缺失具体内容）
