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Chemometric-based AQbD and Green Chemistry Approaches to Chromatographic Analysis of Remogliflozin Etabonate and Vildagliptin.

BACKGROUND
According to the green chemistry approach, during method development, the usage of toxic and carcinogenic organic solvents should be avoided or minimized for the safety of the environment and analysts. The chromatographic methods such as RP-HPLC and HPTLC include the usage of class 2 organic solvents as per ICH Q3C (R6) guideline. The chromatographic analysis by HPTLC requires less organic solvent as compared to the RP-HPLC method.


OBJECTIVE
Hence, HPTLC-based chromatographic analysis of vildagliptin (VIL) and remogliflozin Etabonate (RMG) has been carried out using green chemistry and AQbD approaches.


METHOD
The PCA-based chemometric analysis was applied for the identification of critical method variables for the development of the method. The DoE-based Box-Behnken design was applied for response surface modelling and optimisation of critical method variables. The analytical design space and analytical control point were navigated for the development of the HPTLC method as per QTAP.


RESULTS
The chromatographic analysis of VEL and RMG was carried out using silica gel G60 F254 as stationary phase and acetone - ethyl acetate -water-TEA (7.0 + 2.5 + 0.3 + 0.2, v/v) as mobile phase. The HPTLC method was validated as per ICH Q2 (R1) guideline. The HPTLC method was applied for the assay of FDCs of VIL and RMG and the results were found to comply with their labelled claim.


CONCLUSION
The developed method included the usage of organic solvents which are belonging to the class-3 category as per the ICH Q3C (R6) guideline. Hence, the developed method can be used as an eco-friendly alternative to published chromatographic methods for quality control and routine analysis of FDCs of VIL and RMG in the pharmaceutical industry.


HIGHLIGHTS
Chromatographic analysis of vildagliptin and remogliflozin etabonate using green chemistry and AQbD approaches. Application of the method for assay of drugs in their combined pharmaceutical dosage forms.