Development and validation of a UV spectrophotometric method for simultaneous estimation of teneligliptin hydrobromide hydrate and pioglitazone hydrochloride in pharmaceutical dosage form

Background

This study presents the development and validation of a UV spectrophotometric method for the simultaneous estimation of teneligliptin hydrobromide hydrate (TEN) and pioglitazone hydrochloride (PIO) in pharmaceutical dosage forms. The method measures absorbance at 243 nm for TEN and 265 nm for PIO. Validation was conducted according to ICH guidelines, covering specificity, linearity, range, precision, accuracy, limit of detection, limit of quantification, and robustness.

Results

The method exhibited linearity in the 2–25 µg/ml concentration range for both TEN and PIO, with correlation coefficients close to 1. Precision studies showed low % RSD values, indicating excellent repeatability and minimal intra- and inter-day variability. Accuracy was confirmed through recovery studies, with results within the 98–102% range. The method demonstrated sensitivity with low LOD and LOQ values. Robustness testing showed stability and consistency under varying conditions. Analysis of tablet formulations confirmed the accurate quantification of both drugs.

Conclusion

The developed UV spectrophotometric method offers a simple, sensitive, and cost-effective solution for the simultaneous estimation of TEN and PIO in pharmaceutical formulations. It is suitable for routine analysis and quality assessment of tablet dosage forms.