Several spectrophotometric and HPLC methods have been reported for the determination of
Ertugliflozin and Sitagliptin in drugs and pharmaceutical dosage forms. In the present study, a
new, sensitive, suitable, and robust reversed-phase high-performance liquid chromatography
(RP-HPLC) method was developed and validated for the determination of Ertugliflozin and
Sitagliptin in bulk drug and tablet formulation. The RP-HPLC method utilized Methanol and
Water (75:25 % v/v) as the mobile phase at a flow rate of 1.0 ml/min on an HPLC system with
a UV detector, using Openlab EZchrome software and a Kromasil C18 column (250 mm x 4.6
mm, 5 ?m). Detection was carried out at 258 nm, providing suitable retention times of 3.60
min for both Ertugliflozin and Sitagliptin.
The method was validated according to ICH guidelines, assessing filter study, solution stability,
specificity, linearity, accuracy, precision (repeatability and intermediate precision), limit of
detection, limit of quantification, and robustness. The developed method demonstrated
simplicity and precision for the assay of Ertugliflozin and Sitagliptin in bulk drug and tablet
formulations. It requires regular reagents and is less time-consuming, making it suitable for
routine analysis in the pharmaceutical industry.
This research article will discuss the method development process, optimization of
chromatographic conditions, detailed validation results, and the applicability of the method for
routine quality control of Ertugliflozin and Sitagliptin in pharmaceutical formulations.
Keywords: RP-HPLC, Ertugliflozin, Sitagliptin, Method Development, Validation, Bulk
Drug, Dosage Form
Publication date: 01/12/2025
https://ijbpas.com/pdf/2025/December/MS_IJBPAS_2025_9615.pdf
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https://doi.org/10.31032/IJBPAS/2025/14.12.9615
