Composition of the formulated gel.

For routine measurement of Voriconazole (VZ) in a pure and gel formulation, a quick and accurate RP-HPLC technique with UV detection (254 nm) was developed. With a flow rate of 1.0 ml/min using a mobile phase that contained acetonitrile and water mixed 50:50, v/v. Internal standard approach was used for quantification. The method shows good linearity (correlation coefficient = 0.9999) with acceptable accuracy, precision and robustness. Three elements were taken into account to measure robustness. Flow rate, mobile phase composition, and pH all have an impact on the response, but only the flow rate which causes a reduction in the concentration of the drug—has a significant impact on the response. Analyst, equipment, and days were taken into consideration for a precision measurement. The analytical procedure had good precision, as seen by the %RSD which is found to be less than 2.0. The proposed method was straightforward, extremely sensitive, exact, and accurate, and it had a retention time of less than 4 minutes, indicating that it is appropriate for daily quality control.

本研究针对纯品及凝胶制剂中的伏立康唑（Voriconazole，VZ）日常定量检测需求，开发了一种快速准确的反相高效液相色谱法（RP-HPLC），采用紫外检测（UV detection，波长254 nm）。该方法以体积比50:50的乙腈-水溶液作为流动相，流速设置为1.0 ml/min，并采用内标法（internal standard approach）进行定量分析。该方法具备良好的线性关系，相关系数达0.9999，同时具有可接受的准确度、精密度与耐用性。本研究从流速、流动相组成及pH值三个维度考察方法耐用性，上述因素均会对检测响应产生影响，但仅流速变化会通过降低药物浓度进而对检测响应产生显著影响。精密度考察纳入了分析人员、仪器设备与检测天数三个变量，结果显示方法精密度良好，测得的相对标准偏差（%RSD，relative standard deviation）均小于2.0%。所建立的分析方法操作简便、灵敏度极高、专属性强且准确度佳，药物保留时间不足4分钟，适用于日常质量控制检测。