Spectrophotometric Methods for Simultaneous Development and Validation of Anti-diabetic drug Alogliptin and Canagliflozin

Abstract

Background

Alogliptin (ALO) selective inhibitor of dipeptidyl peptidase-4 (DPP-4) and Canagliflozin is the sodium-glucose cotransporter-2 (SGLT-2) inhibitor against type 2 diabetes mellitus.

Purpose

The study aimed to spectrophotometric simultaneous novel method development and validation of antidiabetic drugs Alogliptin (ALO) and Canagliflozin (CANA).

Results

A linear response was observed over a concentration range of 10–100 µg/mL for both compounds, achieving high correlation coefficients (R²) of 0.999, indicating excellent analytical reliability. The limits of detection (LOD) for CANA and ALO were determined to be 1.65 µg/mL and 8.8 µg/mL while the limits of quantification (LOQ) for CANA and ALO were 5.0 µg/mL and 26 µg/mL, respectively. The method was rigorously validated as per International Conference on Harmonization (ICH) Q2R1guidelines, assessing key parameters such as linearity, precision, accuracy, sensitivity, and robustness. Intra-day and inter-day precision studies yielded relative standard deviation (RSD) values below 2%, confirming the method’s reproducibility. Recovery studies demonstrated high accuracy, with recovery values for CANA and ALO ranging from 98 to 102%, further validating the method’s effectiveness. The study also evaluated the ruggedness of the method, with results showing acceptable limits and a % RSD value of less than 2% across different analysts and trials.

Conclusion

The UV spectrophotometric method developed is simple, cost-effective, and timesaving, making it suitable for routine estimation of ALO and CANA in both bulk and dosage forms. This method can be effectively applied for quality control, pharmacokinetic, and stability studies, thereby contributing significantly to the field of pharmaceutical analysis.