Stability-Indicating Analytical Method Development and Validation for Evogliptin in Pharmaceutical Dosage Form

Abstract

A rapid, sensitive, specific, and stability-indicating RP-HPLC method was developed for the quantification of Evogliptin in tablet dosage forms. Chromatographic separation was achieved using Altima C18 (4.6 × 150 mm, 5 µm) column with a mobile phase of 0.01N KH2PO4 and acetonitrile in the ratio of 60:40 v/v. The flow rate was 1.0 mL/min, and detection was carried out at 234 nm. The retention time of Evogliptin was 2.802 minutes. The method was validated as per ICH Q2(R1) guidelines and showed excellent linearity (5–30 µg/mL), accuracy (99.30%), and precision (%RSD < 2%). The LOD and LOQ were 0.24 and 0.73 µg/mL, respectively. The method was found to be robust and specific and can be employed for routine quality control and stability analysis of Evogliptin in pharmaceutical dosage forms. Index Terms— Evogliptin, Method Development, RP-HPLC, Validation.

Keywords

Introduction

II. MATERIALS AND METHODS:

Figure 1: System suitability Chromatogram

Figure: 2 Repeatability Chromatogram

Figure: 3 Intermediate Precision Table of Evogliptin

Figure: 4 Calibration curve of Evogliptin

Table: 5 Robustness Data for Evogliptin

Table: 6 Accuracy Table of Evogliptin

Forced Degradation Studies:

The formulation was tested under degradation conditions and the degraded samples were injected. The assay results were within acceptable limits, indicating all samples passed.

Table: 7 Degradation Data of Evogliptin

IV. CONCLUSION

• A sensitive, specific and precise RP-HPLC method for the pharmaceutical dose estimation of Evogliptin.
• Retention time of Evogliptin was found to be 2.802 min.
• %RSD of the Evogliptin were  found to be 0.9.
• %RSD of Method precision of Evogliptin was found to be 0.6.
• %Recovery was obtained as 99.30% for Evogliptin.
• LOD, LOQ values obtained from regression equation of Evogliptin were 0.24µg/ml, 0.73µg/ml
• Regression equation of Evogliptin is y = 38273x + 2490.1.

Retention times were decreased and that run time was decreased, so the method developed was efficient that can be adopted in regular Quality control test in day-to-day analysis.

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