Development and Validation of New Analytical RP-HPLC Method for the Estimation of Antidiabetic Drugs Metformin Hydrochloride and Ertugliflozin in Combined Pharmaceutical Dosage Form

Khoja, Suleman S.; Patel, Laxman J.

doi:10.35652/igjps.2021.111009

Cited by 2 publications

(1 citation statement)

References 8 publications

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“…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] .…”

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confidence: 99%

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2023

IJPSR

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The concept of quality by design (QbD), which entails understanding the essential components and their interaction effects by a desired set of tests, has lately gained relevance in developing analytical. To validate the simultaneous quantification of Ertugliflozin and Sitagliptin in bulk drugs and its pharmaceutical formulation, the present study discusses the development of the Reverse Phase-High Performance Liquid Chromatography (RP-HPLC) method by the QbD methodology employing the Design of Experiments. The three essential elements of the RP-HPLC method-Flow rate (ml/min), Mobile phase (%), and temperature ( o C) are systematically explored in an effective experimental design that is provided. Statistical analysis tools were used to assess the significant impact of these parameters and their interactions with the response variables (Retention time and tailing factor). The 260nm optimized wavelength was chosen. Ertugliflozin and Sitagliptin were shown to have retention times of 3.897 and 2.527 minutes, respectively. Ertugliflozin and Sitagliptin can be estimated simultaneously using a linear method over the ranges of (1.875-11.25 g/ml) and (12.5-75 g/ml), respectively. The correlation coefficient R2 for Ertugliflozin and Sitagliptin are 0.9993 and 0.9995. The method's %RSD for precision and accuracy was discovered to be under 2%. Studies on forced degradation concluded that the strategy indicated stability. Ertugliflozin and Sitagliptin both had %Recovery values of 99.81% and 99.84%, respectively. Retention time and run time decreased, so the method developed was simple and economical and can be adopted in regular Quality control test in Industries. INTRODUCTION:A Quality by Design approach is outlined as a system for planning, analyzing, and dominant manufacturing through timely measurements of essential quality and performance attributes of recent and in-process materials and processes, aiming to ensure the ultimate product safety.

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confidence: 99%

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2023

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An Overview on Analytical Method Development and Validation for Ertugliflozin in Bulk and Pharmaceutical Dosage form

M. Sagar,

Mankar,

Dighe

2023

AJPA

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Diabetes mellitus (DM) is a metabolic condition characterized by hyperglycemia, glycosuria, hyperglycemia, a negative nitrogen balance, and occasionally ketonemia. The type 2 sodium-dependent glucose co-transporters (SGLT), which are in charge of roughly 90% of the reabsorption of glucose from the glomerulus, are subject to strong and selective inhibition by ertugliflozin. This review's primary objective is to highlight the development and validation of analytical methods employing chromatographic and spectrophotometric techniques for ertugliflozin and combination products in bulk and pharmaceutical dose forms. RP-HPLC, UV, UPLC, and LC-MS techniques are used to determine the dosage of ertugliflozin when it is combined with metformin and sitagliptin. Spectrometric techniques for ertugliflozin in combination with metformin or sitagliptin contain parameters like solvent, wavelength, linearity, LOD, LOQ, etc., and HPLC methods for ertugliflozin in combination with metformin or sitagliptin include parameters like stationary phase, mobile phase, RT, detection wavelength, LOD, LOQ, etc. Discussions on the separation requirements for ertugliflozin in combination with metformin or sitagliptin are also addressed throughout this review.

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Development and Validation of New Analytical RP-HPLC Method for the Estimation of Antidiabetic Drugs Metformin Hydrochloride and Ertugliflozin in Combined Pharmaceutical Dosage Form

Cited by 2 publications

References 8 publications

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An Overview on Analytical Method Development and Validation for Ertugliflozin in Bulk and Pharmaceutical Dosage form

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