Novel stability-indicating RP-UPLC method for simultaneous estimation of sitagliptin and ertugliflozin in bulk and pharmaceutical formulations

Abstract

Background The present investigation was proposed to develop a simple, sensitive, rapid, accurate, precise stability-indicating RP-UPLC method for simultaneous estimation of sitagliptin and ertugliflozin. Chromatographic separation was performed with Waters Hibar C8 [100×2.1mm, 2μ] column and mobile phase acetonitrile: water (pH 3.5) [50:50%, v/v], pumped at a flow rate 0.2ml/min. The separated analytes were detected with a UV detector at a wavelength of 218nm. Results The separation of sitagliptin and ertugliflozin was done at a retention time of 0.859min and 1.570min, respectively. The present method was validated according to the ICH guidelines Q2 R1, and stability-indicating studies were carried out as per ICH guidelines Q1A R2. Intra-day and inter-day precision were found to be within acceptable limits. The linearity of the proposed method was in the concentration range of 25–125μg/ml and 3.75–22.5μg/ml for sitagliptin and ertugliflozin, respectively. Limit of detection (LOD) and limit of quantification (LOQ) were found to be 0.5μg/ml and 1.53μg/ml for sitagliptin and 0.13μg/ml and 0.38μg/ml for ertugliflozin, respectively. The recovery of the method was found in between 99.7% and 100.7%. Conclusion The proposed method was able to distinguish the analytes from by-products. Hence, the method was successfully implied for stability-indicating studies and for routine examination of sitagliptin and ertugliflozin in pharmaceutical formulation.

Comparing the Greenness and Validation Metrics of Traditional and Eco-Friendly Stability-Indicating HPTLC Methods for Ertugliflozin Determination

“…ERZ has also been determined in combination with sitagliptin using LC mass spectrometry (MS)/MS (LC-MS/MS) method in fixed-dose combination products . Using LC-MS/MS techniques, ERZ has also been quantified in rat plasma samples in conjunction with sitagliptin or metformin. , The determination of ERZ in pure forms and pharmaceutical preparations, either in conjunction with sitagliptin or alone, has also been performed utilizing various ultraperformance LC-MS/MS (UPLC-MS/MS) techniques. − Using a UPLC-MS/MS approach, ERZ and sitagliptin have also been measured simultaneously in rat plasma samples . A green spectrofluorometric method was also used to determine ERZ in dosage forms and human urine samples .…”

Identification, isolation, and structural characterization of novel forced degradation products of Ertugliflozin using advanced analytical techniques

“…Scrutinizing the literature discovered few publications on the analysis of Ertugliflozin unique and combined with metformin and sitagliptin. Ertugliflozin strategy development was reported for its combination with metformin RP-HPLC 5 – 11 , with sitagliptin 12 – 18 , in combination with both metformin and sitagliptin 19 . Several bioanalytical strategies utilizing LC–MS/MS approaches have been reported to detect sitagliptin in plasma and Ertugliflozin 20 , 21 .…”

Untitled

“…But until work, no Quality by Design (QbD) is applied for combination drugs that give robust, economic, and quick results. The objective of the present work was to develop easy, rapid, accurate, specific, and economic stability indicating RP-HPLC method using QbD approach for the Ertugliflozin and Sitagliptin in bulk and tablet form [11][12][13][14][15][16][17] .…”