A highly accurate, simple and sensitive spectrofluorimetric analytical method for dapagliflozin (DGF) quantitation was developed. The proposed method was successively applied to DGF analysis in both its pure and pharmaceutical dosage forms. This method was developed to investigate DGF stability in its degradation products, as laid out in International Council for Harmonisation (ICH) rules. Kinetics of alkaline degradation of DGF was also calculated. The half-life time (t1/2 ) of the reaction was 75.32 min. An alkaline degradation pathway was described. The present study involved measurement of the second-derivative synchronous fluorescence intensity of DGF at Δλ = 30 nm. Peak amplitude was measured at 322 nm. Linear range of the calibration curve was 0.1-1.0 μg ml-1 . Lower detection and quantitation limits were 0.023 and 0.071 μg ml-1 , respectively, and indicated good sensitivity of the proposed method. Mean per cent recovery was 99.78 ± 1.78%. The proposed analytical approach was successfully applied to DGF in the quality control laboratory and would be suitable as a stability-indicating assay.

中文翻译：

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达格列净的二阶导数同步荧光法测定：在稳定性研究和药物制备中的应用。

开发了一种用于dapagliflozin（DGF）定量的高精度，简单且灵敏的荧光光谱分析方法。所提出的方法先后应用于纯药物剂型和药物剂型的DGF分析。根据国际协调委员会（ICH）规则，开发了此方法以研究DGF在其降解产物中的稳定性。还计算了DGF的碱性降解动力学。反应的半衰期（t1 / 2）为75.32分钟。描述了碱性降解途径。本研究涉及在Δλ= 30 nm下测量DGF的二阶导数同步荧光强度。在322nm处测量峰幅度。校准曲线的线性范围为0.1-1.0μgml-1。较低的检测和定量限是0.023和0.071μgml-1，分别表明该方法具有良好的灵敏度。平均回收率为99.78±1.78％。所提出的分析方法已在质量控制实验室中成功应用于DGF，适合作为稳定性指示试验。