DEVELOPMENT AND VALIDATION OF A STABILITY-INDICATING HPTLC METHOD FOR VONOPRAZAN FUMARATE WITH GREEN CHEMISTRY ASSESSMENT
Santosh V. Gandhi* and Rutuja M. Bacche
ABSTRACT
A novel, eco-friendly high-performance thin-layer chromatographic (HPTLC) method was developed and validated for the quantification of Vonoprazan fumarate in bulk and tablet dosage forms. The separation was achieved on silica gel 60 F254 plates using a mobile phase comprising methanol, ethyl acetate and formic acid (8.5:1:0.5 v/v/v). Densitometric detection was carried out at 266 nm. The method exhibited excellent linearity over the range of 1000–6000 ng/spot, with high precision and accuracy (99.05 – 100.10 %), as well as acceptable robustness. Specificity was established through forced degradation studies under acidic, alkaline, oxidative, thermal, and photolytic conditions, confirming the method's stability-indicating capability. The environmental sustainability of the method was assessed using three complementary tools like. Green Analytical Procedure Index (GAPI), Analytical GREEnness (AGREE) metric, and Whiteness Index, all of which confirmed its green profile. This validated method is simple, rapid, economical and suitable for routine analysis in quality control settings.
Keywords: Chromatographic analysis, Eco-friendly method, Tablet analysis, Analytical greenness, Stability testing.
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