紫外分光光度法测定Pretomanid的建立与验证

Vaishali Pardeshi, Tushar Lokhande, Ashwini Shelke
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引用次数: 0

摘要

为了治疗耐多药结核病,与其他抗结核药物一起使用了一种硝基咪唑嗪类抗细菌剂pretomanid。目前还没有光谱、高效液相色谱或HPTLC分析技术。由于紫外分光光度法分析Pretomanid必须发展。利用岛津UV-2600,设计了一种快速、准确、直接、经济的紫外分光光度法来测定Pretomanid。用甲醇配制的溶剂来评估Pretomanid的体积浓度。检测过程的波长为321 nm。根据ICH Q2R1标准以及定量限和定量限进行方法验证,考虑参数的线性、准确度、精密度、坚固性和稳健性。在10 ~ 30(g/mL)范围内呈良好的线性关系,在321 nm范围内具有较强的相关系数(r2 ~ 0.997),平均回收率为99.00 ~ 100.07%。在日内和日间精度方面,Pretomanid的% RSD分别为0.6366和0.666。用这种方法鉴定Pretomanid是有效的。方法的线性度、准确度、重复性和再现性经统计学和经验验证。结果表明,该方法适用于原动物体和工业制剂的常规检查。经验证,该方法简便、准确、精密度高、快速,符合ICH要求。
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Development and Validation of Simple UV Spectrophotometric Method for the Determination of Pretomanid
In order to treat multidrug resistant TB, pretomanid, a nitroimidazooxazine antimycobacterial agent, is used with other antituberculosis medications. There is no technique for its analysis that uses spectroscopy, HPLC or HPTLC. Since a UV spectrophotometric approach for Pretomanid analysis must be developed. Utilizing a Shimadzu UV-2600, a quick, accurate, straightforward, and affordable UV spectrophotometric approach has been devised to determine Pretomanid. Solvent made of methanol to assess the bulk Pretomanid concentration. The detection process was placed at a wavelength of 321 nm. The parameters linearity, accuracy, precision, ruggedness, and robustness were taken into consideration during method validation in accordance with ICH Q2R1 criteria, as well as LOD and LOQ. It demonstrated linearity in the 10– 30(g/mL) range at a predetermined max of 321 nm, and had a strong correlation coefficient (R2-0.997) and outstanding mean recovery (99.00–100.07%). In terms of intraday and interday precision, Pretomanid’s% RSD was discovered to be 0.6366 and 0.666, respectively. Pretomanid identification using this approach was effective. The method’s  linearity,  accuracy,  repeatability, and reproducibility were statistically and empirically verified. The out- comes demonstrated the method’s applicability for both routine examinations of protomanid bulks and industrial formulations. The suggested UV-Vis Spectrophotometric approach was verified in accordance with ICH requirements and found to be simple, accurate, precise and quick for the determination of Pretomanid.
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