Stability Indicating Method Development and Validation of Teneligliptin by UHPLC Method in Bulk and Pharmaceutical Dosage Form

Background

Teneligliptin is a new drug recently approved by FDA for treatment of type 2 Diabetes Mellitus (DMT 2). Very few methods have been reported for analysing its degradation products and their impact on human health.

Materials and Methods

A precise, specific, and sensitive gradient UHPLC technique was developed and validated to analyze Teneligliptin using an Agilent C18 column (4.6x100 mm ID) with 2.5 μm particle size. The method employs a flow rate 0.9 mL/min and detects the teneligliptin at a wavelength 241 nm. This method comprises a mobile phase consists a mixture of Methanol with 0.1% TEA (60:40%v/v), along with a 20 μL injection volume for duration of 20 min.

Results

Linearity was found in the range of 2-10 μg/ mL having a correlation coefficient of 0.999. The retention time for Teneligliptin was found to be 2.382. Furthermore, the precision and robustness of the method were validated with a remarkable RSD (Relative Standard Deviation) below 2%.

Conclusion

The method’s stability under various stress conditions was confirmed through forced degradation studies conducted on both bulk substances and pharmaceutical dosage forms. Validation of the method followed the guidelines outlined by the ICH for assessing the validation parameters like specificity, linearity, accuracy, precision, robustness, LOQ and LOD.