Institute of Pharmaceutical Research, GLA University, NH-2, Mathura-Delhi Road, Mathura, UP, 281 406, India.
Department of Pharmacy, Birla Institute of Technology and Science-Pilani, Pilani Campus, Rajasthan-333031, India.
Anal Methods. 2024 Aug 1;16(30):5280-5287. doi: 10.1039/d4ay00943f.
The stability-indicating approach for tavaborole quantification was developed and validated to establish a precise, linear, accurate, and robust HPLC method. The development section includes optimizing the detection wavelength, the mobile phase ratio, and the type of column used to achieve the best possible separation and sensitivity for analysis. The chromatographic conditions were established, considering peak symmetry, resolution, and retention time. The mobile phase composition, comprising a buffer: acetonitrile (75 : 25, %v/v), with an injection volume of 15 μL, showed suitable elution and recovery at 265 nm. A constant column oven temperature of 35 °C and a 1 mL min flow rate were maintained. The pH of the buffer was changed to 3.0 by using orthophosphoric acid. Linearity was observed from 5 to 1000 ppm ( = 1.00000). The capacity (retention) factor () of 3.43 was observed, indicating significant interaction and good separation. Forced degradation (FD) or stress tests were performed for chemical and physical photolytic stress conditions, and the results observed were within the specified limits. The stability in the analytical solution was observed for up to 35 hours at 5 °C, confirming the stability of the solution. Validation of the developed HPLC method confirmed the system's suitability, precision, linearity, accuracy, FD, robustness, and results. All validation criteria for the technique were within acceptable limits.
建立了一种用于他唑巴坦定量的专属性分析方法，并对其进行了验证，以建立一种精确、线性、准确和稳健的 HPLC 方法。开发部分包括优化检测波长、流动相比例和所用柱的类型，以实现最佳的分离和分析灵敏度。考虑到峰对称性、分辨率和保留时间，建立了色谱条件。流动相组成包括缓冲液：乙腈（75：25，%v/v），进样体积为 15 μL，在 265nm 处显示出合适的洗脱和回收率。保持柱箱温度恒定在 35°C，流速为 1mL/min。使用正磷酸将缓冲液的 pH 值调至 3.0。在 5 至 1000ppm（=1.00000）范围内观察到线性。观察到的容量（保留）因子（）为 3.43，表明存在显著的相互作用和良好的分离。对化学和物理光解胁迫条件进行了强制降解（FD）或胁迫试验，观察到的结果在规定的限度内。在 5°C 下，分析溶液的稳定性可长达 35 小时，证实了溶液的稳定性。对所开发的 HPLC 方法进行验证，确认了系统的适用性、精密度、线性、准确性、FD、稳健性和结果。该技术的所有验证标准均在可接受范围内。
