Comparison of Validation Parameters for the Determination of Vitamin D3 in Commercial Pharmaceutical Products Using Traditional and Greener HPTLC Methods

Several analytical methods are documented for the estimation of vitamin D3 (VD3) in pharmaceuticals, food supplements, nutritional supplements, and biological samples. However, greener analytical methods for VD3 analysis are scarce in the literature. As a consequence, attempts were made to design and validate a greener high-performance thin-layer chromatography (HPTLC) method for VD3 estimation in commercial pharmaceutical products, as compared to the traditional HPTLC method. The greenness indices of both approaches were predicted by utilizing the Analytical GREENness (AGREE) method. Both traditional and greener analytical methods were linear for VD3 estimation in the 50-600 ng band(-1) and 25-1200 ng band(-1) ranges, respectively. The greener HPTLC strategy outperformed the traditional HPTLC strategy for VD3 estimation in terms of sensitivity, accuracy, precision, and robustness. For VD3 estimation in commercial tablets A-D, the greener analytical strategy was better in terms of VD3 assay over the traditional analytical strategy. The AGREE index of the traditional and greener analytical strategies was estimated to be 0.47 and 0.87, respectively. The AGREE analytical outcomes suggested that the greener analytical strategy had a superior greener profile to the traditional analytical strategy. The greener HPTLC strategy was regarded as superior to the traditional HPTLC methodology based on a variety of validation factors and pharmaceutical assays.

Automated summary

The study aimed to design and validate a greener HPTLC method for the estimation of VD3, which provided better accuracy and precision in VD3 analysis in commercial pharmaceutical products and demonstrated superior greenness profile compared to traditional methods.