INTRODUCTION:

One condition that affects people all around the world is diabetes mellitus. The intended glycaemic control and patient outcomes have not yet been fully attained, despite the availability of numerous treatment methods. Therefore, there is an unmet need to provide new medications that would help the majority of patients. One such promising class of newly developed medications for the treatment of diabetes is sodium glucose co-transporter type 2 inhibitors (SGLT2 inhibitors). The pharmaceutical industry has faced difficulties in producing and processing medications that are SGLT2 inhibitors.¹

Ertugliflozin 5, also known as MK-8835, is chemically (1S,2R,3S,4R, 5S)-5- {4-chloro-3- [(4-ethoxy phenyl) methyl] phenyl}-1-(hydroxymethyl)-6,8-dioxabicyclo [3.2.1] octane-2,3,4-triol. On December 19, 2017, Ertugliflozin received its first worldwide approval in the USA as a supplement to diet and exercise to improve glycaemic control in adults with type-II diabetes. In January 2018, the EU Committee for Medicinal Products for Human Use (CHMP) gave it a positive opinion, and it is currently awaiting approval in the EU. Pfizer, Merck Sharp, and Dohme Corp. manufacture and market it under the names Steglatro, Segluromet, and Steglujan, respectively, to improve glycaemic control in adults with type-II diabetes. Ertugliflozin is rapidly absorbed, with a T-max of 1.0 hours. Humans absorb it well, and glucuronidation is the main way it is removed. Additionally, it lowers triglyceride levels, but there have been reports of a little rise in LDL and HDL cholesterol levels. The majority of the adverse effects are mild to moderate in severity, and it is well tolerated. Ertugliflozin therapy is not advised for patients with moderate renal impairment, renal diseases, or dialysis patients due to the most common side effects, which include genital mycotic and urinary tract infections.²

Ertugliflozin is an inhibitor of the sodium glucose co-transporter (SGLT2). SGLT2 inhibitors lower fasting and postprandial blood glucose levels by increasing urine glucose excretion and decreasing renal glucose reabsorption. It is a white powder that dissolves in ethanol and acetone, is only weakly soluble in acetonitrile and ethyl acetate, and is only weakly soluble in water. It can be purchased commercially as a solo medication or in combination with metformin hydrochloride and sitagliptin.³

5 mg of ertugliflozin administered once daily in the morning, with or without meals, is the suggested first dosage ^4. The 5 mg dose may be raised to a maximum of 15 mg once daily if more glycaemic management is required and it is tolerated ^3. In the USA, ertugliflozin and metformin (SeglurometTM) ⁵ and ertugliflozin and sitagliptin (SteglujanTM) ⁶ have also been licensed as fixed-dose combinations (FDCs) to treat people with type 2 diabetes as a supplement to diet and exercise.^7,8

Mechanism of Action:

Like other sglt2 inhibitors, ertugliflozin very selectively inhibits SGLT2 to lower the renal threshold for glucose and decrease renal reabsorption of filtered glucose, both of which raise urine glucose excretion (UGE).^9,10 When SGLT2 inhibitors are used, glucose is reabsorbed into the bloodstream, which causes glucosuria. Ertugliflozin functions independently of insulin secretion and sensitivity, just as other SGLT2 inhibitors. Together with insulin, ertugliflozin works in concert with other oral medications, particularly metformin, sitagliptin, and sulfonylureas. When combined with medications that have a known risk of hypoglycemia, such as insulin and sulfonylureas, ertugliflozin may raise the risk of hypoglycemia, even though it poses low risk on its own.¹¹

Physical and Chemical Property:

Ertugliflozin's IUPAC name is (1S,2S,3S,4R,5S). [(4-ethoxyphenyl) methyl] phenyl -5-[4-chloro-3-] 1-hydroxy-2-methyl-3-oxycyclohexane (tetrahydro-2H-pyran-2-yl). Ertugliflozin's chemical formula is C22H25ClO7. The weight of the molecule is 436.88 g/mol. Ertugliflozin is nearly insoluble in non-polar organic solvents, readily soluble in methanol and ethanol, and just weakly soluble in water. Ertugliflozin is Steglatro's active pharmaceutical ingredient (API); Figure 1 roughly depicts its chemical structure.¹²

Fig. 1: Chemical Structure of Ertugliflozin

Commom Chromatographic Techniques

1. UV Spectrophotometry:

The absorption or reflectance spectroscopy of the ultraviolet and nearby visible portions of the electromagnetic spectrum is known as UV spectroscopy. Another name for it is UV-visible spectrophotometry, sometimes referred to as UV-Vis or UV/Vis. This methodology is frequently employed in many practical and fundamental applications due to its low cost and simplicity of implementation. The sample just needs to absorb in the UVVis range to be identified as a chromophore. Absorption spectroscopy supplements fluorescence spectroscopy. Aside from the wavelength, the characteristics of importance are absorbance (A), reflectance (%R) and transmittance (%T), together with how they change over time.¹³

2. High-Performance Liquid Chromatography (HPLC)

To guarantee the quality and safety of the drug, drug production control necessitates extensive and high-level analytical and chemical support at every stage ^[14] The pharmacopoeia is a set of suggested methods for analysis and specifications for identifying pharmaceutical ingredients, excipients, and dosage forms. It is meant to be used as a source of information for anyone looking to meet pharmaceutical requirements or modify it. High Performance Liquid Chromatography (HPLC) is the separation technology that is most frequently employed in the different stages of drug research and manufacture. Understanding the fundamentals of the chromatographic process and the rationale for the selection of the chromatographic system's components, including the column, mobile phase, and detectors, are essential for the correct operation of an HPLC system. At normal flow rates of 0.5-2 ml/min, the mobile phase must be forced through the column by a high-pressure pump. Before the column, a manual or automatic injection device introduces the sample to be separated into the mobile phase. The mobile phase, which carries the sample components eluting from the column, passes through a low volume cell that is typically used in detectors.¹⁵

3. Ultra-High Performance Liquid Chromatography (UHPLC):

Ultra Performance Liquid Chromatography is referred to as UPLC. Chromatographic resolution, speed, and sensitivity analysis are the three areas where it improves. It saves time, employs fine particles, and requires less solvent^16. HPLC is the source of UPLC. The packing materials required to produce the separation have evolved with HPLC. According to a fundamental HPLC concept, efficiency and, consequently, resolution rise when column packing particle size decreases. According to the standard Van Demeter equation, efficiency increases significantly as particle size drops to less than 2.5µm and does not decline at higher linear velocities or flow rates.¹⁷

4. Reverse Phase High Performance Liquid Chromatography (RP-HPLC)

For the analysis of pharmaceutical compounds, reversed phase liquid chromatography (RPLC) is the preferred technique for a number of reasons, including its high consistency and repeatability, compatibility with various detection systems, and compatibility with both organic and aqueous solutions. Whether in the bioanalytical or pharmaceutical industries, sensitive and precise RPLC analysis requires the use of stationary phases that produce symmetrical and effective peaks. As a result, producers of stationary phases are constantly developing and launching new RPLC products, and there is a wide range of reversed phase stationary phase options available.

The methodologies must be translated from one location to another utilising the same column brands or their equivalents due to the need for uniformity and the globalisation of pharmaceutical firms. As a result, a thorough classification or description of the wide range of stationary phases has been carried out recently.^18-24

Reported Method for Ertugliflozin:

Ertugliflozin is a widely used sodium-glucose co-transporter-2 (SGLT2) inhibitor, and the development of reliable analytical methods is crucial to ensuring its efficacy, safety, and quality in pharmaceutical applications. Numerous studies have explored and reported various analytical techniques for ertugliflozin quantification in recent years, focusing on both biological matrices and pharmaceutical formulations. These methodologies include mass spectrometry (MS), UV spectrophotometry, and high-performance liquid chromatography (HPLC)—each contributing to advancements in sensitivity, specificity, and environmental sustainability in ertugliflozin analysis. By systematically reviewing the available literature, researchers can identify technological progress and existing gaps, particularly in developing green analytical methods and highly sensitive clinical approaches. For researchers and clinicians aiming to refine traditional methodologies, determine optimal techniques for specific applications, and address modern challenges in pharmaceutical analysis, this comparative study serves as a valuable resource.

Poonam Dada Waditake her co-workers published the paper in the year 2024 The study developed and validated a stability-indicating RP-HPLC method for quantifying Remogliflozin Etabonate (REM) in human plasma. Using a Thermo C18 column and a mobile phase of methanol and 0.1% acetic acid (80:20 v/v), the method exhibited a retention time of 4.4 min, linearity in the 5-13 µg/mL range (R² = 0.9992), and high accuracy with recovery above 98%. LOD and LOQ were 0.13 µg/mL and 0.42 µg/mL, respectively. Stability studies showed REM was highly susceptible to acid, base, and peroxide degradation but stable under neutral and photolytic conditions. The method proved robust, precise, and suitable for routine analysis in biological samples.²⁵

Parameters	Description
Column Name	THERMO C18 (250×4.6 mm, 5 µm)
Mobile Phase	Methanol and 0.1% acetic acid in a ratio of 80:20 (v/v).
Flow Rate	1.0 mL/min.
Detection	Ultraviolet detection at a wavelength of 224 nm.
Retention Time	4.4 min.

Jayshree Bamniya and her co-workers published the paper in the year 2022The study developed a stability-indicating RP-HPLC method for evaluating the stress degradation profile of Ertugliflozin. The method used a Kromasil C18 column with a mobile phase of 0.1% formic acid in water and acetonitrile (70:30 v/v) at a flow rate of 1.0 mL/min, detecting Ertugliflozin at 224 nm with a retention time of 7.24 min. Forced degradation studies revealed significant degradation under oxidation (61.82%), acid (23.26%), and alkali (37.16%) conditions, while no degradation was observed under thermal and photolytic conditions. The method was validated per ICH guidelines and found suitable for routine analysis of Ertugliflozin in bulk and tablet formulations.²⁶

Parameters	Description
Column Name	Kromasil C18 (5 µm, 250 × 4.6 mm i.d.)
Mobile Phase	A mixture of 0.1% formic acid in water and 0.1% formic acid in acetonitrile in a ratio of 70:30 (v/v)
Flow Rate	1.0 mL/min
Detection	Ultraviolet detection at a wavelength of 224 nm
Retention Time	7.24 in.

S. D. Mankar and her co-workers published the paper in the year 2022The study developed and validated an RP-HPLC method for the simultaneous estimation of Ertugliflozin and Sitagliptin in bulk and tablet dosage forms. Chromatographic separation was performed using a Kromasil C18 column (250 mm × 4.6 mm, 5 µm) with a mobile phase of methanol and 0.1% OPA in water (75:25 v/v) at a 1.0 mL/min flow rate. Retention times for Ertugliflozin and Sitagliptin were 5.30 min and 2.05 min, respectively. The method was precise (%RSD < 2), accurate (recovery 98-102%), and linear (R² = 0.999). Sensitivity tests showed LOD values of 0.091 µg/mL (Ertugliflozin) and 0.960 µg/mL (Sitagliptin). Robustness tests confirmed the method's stability. The validated method is suitable for routine quality control of Ertugliflozin and Sitagliptin tablets.^.27

Parameters	Description
Column Name	Kromasil C18 (5 µm, 250 × 4.6 mm i.d.)
Mobile Phase	Methanol and 0.1% OPA (Orthophosphoric Acid) in water (75:25 v/v)
Flow Rate	1.0 mL/min
Detection	Ultraviolet detection at 212 nm
Retention Time	Ertugliflozin: 5.30 min. Sitagliptin: 2.05 min.

M. R. Ghante andher co-workers published the paper in the year 2022The study developed and validated a stability-indicating RP-HPLC method for estimating Ertugliflozin under forced degradation conditions. Using a HiQ Sil C18 column (150×4.6 mm, 5 µm) with a mobile phase of methanol and water (90:10 v/v) at a flow rate of 0.7 mL/min, the method detected Ertugliflozin at 260 nm with a retention time of 4.1 min. The method was linear (R² = 0.9999) over a 10-90 µg/mL range, precise (%RSD < 2), and accurate (% recovery 98-102%). Forced degradation studies showed significant degradation under acid, base, oxidation, and photolytic conditions, while dry heat had minimal impact. The validated method is suitable for routine quality control of Ertugliflozin in bulk and pharmaceutical dosage forms.²⁸

Parameters	Description
Column Name	HiQ Sil C18 (150×4.6 mm, 5 µm)
Mobile Phase	Methanol and water in a 90:10 (v/v) ratio
Flow Rate	0.7 mL/min
Detection	Ultraviolet (UV) detection at a wavelength of 260 nm
Retention Time	4.1 min.

Satish Shelke and her co-workers published the paper in the year 2021The study developed and validated an RP-HPLC method for determining the impurity profile of Ertugliflozin. The method utilized a Finepack C18 column (250 × 4.6 mm, 5 µm) with a mobile phase of 0.1% OPA + 0.1% TFA (A) and acetonitrile/methanol (40:60 v/v) (B) at an 85:15 ratio, with a flow rate of 1.0 mL/min and detection at 260 nm. The method showed linearity (R² = 0.999) in the 50-150 µg/mL range, accuracy (98.4-100.2% recovery), and stability over 48 hours (<2.0% variation). Three impurities were identified with retention times of 5.71 min (99.54% purity), 13.47 min (99.25%), and 22.70 min (88.74%). The method is suitable for routine impurity profiling of Ertugliflozin.²⁹

Parameters	Description
Column Name	Jasco, Finepack C18 (250 × 4.6 mm, 5 µm)
Mobile Phase	Methanol and water (80:20, v/v)
Flow Rate	1.0 mL/min
Detection	UV detection at 260 nm
Retention Time	5.71 min

Dr. R. Srinivasan her co-workers published the paper in the year 2021. The reseach article provides an updated overview of analytical methods for determining Remogliflozin and Ertugliflozin in pharmaceutical dosage forms. Various chromatographic and spectrophotometric techniques, including RP-HPLC, UV, RP-UPLC, LC-MS, and HPTLC, are summarized. The study highlights different mobile phases, detection wavelengths, linearity ranges, and validation parameters for these methods. It also covers separation conditions for Remogliflozin and Ertugliflozin alone, in combination with other drugs (e.g., Metformin, Sitagliptin), and in the presence of degradation products. This comprehensive review serves as a valuable reference for researchers developing and validating analytical methods for these antidiabetic drugs.³⁰

Parameters	Description
Column Name	ODS RP C18, 5 µm, 15 mm x 4.6 mm
Mobile Phase	80:20 v/v methanol and acetonitrile
Flow Rate	1.0 ml/min
Detection	282 nm
Retention Time	2.545 ± 0.3 minutes

Nandeesha ITIGIMATHA and her co-workers published the paper in the year 2020The study developed and validated simple RP-HPLC and UV spectroscopic methods for determining Remogliflozin Etabonate (RMZ) in bulk and pharmaceutical formulations. The RP-HPLC method used a Kromasil C18 column with a mobile phase of 0.02 M ammonium acetate buffer (pH 4.0), acetonitrile, and tetrahydrofuran (50:45:05 v/v/v) at a 2.0 mL/min flow rate, detecting RMZ at 228 nm. Retention times for RMZ and the internal standard (Atorvastatin) were 6.2 min and 7.0 min, respectively. The method was linear (10-50 µg/mL, R² > 0.999), with LOD and LOQ values of 1.0 µg/mL and 3.5 µg/mL, respectively. The UV method measured absorbance at 228 nm, with linearity in the 100-250 µg/mL range, LOD of 10 µg/mL, and LOQ of 40 µg/mL. Both methods were precise, accurate (recovery 98-102%), and suitable for RMZ quality control.³¹

Parameters	Description
Column Name	Kromasil C18 (5 µm, 250 × 4.6 mm i.d.)
Mobile Phase	A mixture of 0.02 M ammonium acetate buffer (pH 4.0), acetonitrile, and tetrahydrofuran in a ratio of 50:45:05 (v/v/v).
Flow Rate	1.0 mL/min
Detection	Ultraviolet detection at a wavelength of 228 nm.
Retention Time	Remogliflozin Etabonate (RMZ): 6.2 min. Internal Standard (Atorvastatin): 7.0 min.

K. Sravana Kumari and his co-workers published the paper in the year 2020The study developed and validated a stability-indicating RP-HPLC method for the simultaneous estimation of Ertugliflozin Pidolate and Metformin Hydrochloride in bulk and tablet formulations. Using a Kromasil C18 column with a mobile phase of 0.1% ortho-phosphoric acid (pH 2.7) and acetonitrile (65:35 v/v) at a 1.0 mL/min flow rate, the method detected both drugs at 224 nm. Retention times were 2.170 min for Metformin and 2.929 min for Ertugliflozin Pidolate. The method was linear (R² = 0.999) in the ranges of 0.9375–5.625 µg/mL (Ertugliflozin) and 62.5–375 µg/mL (Metformin), with LODs of 0.025 µg/mL and 0.87 µg/mL, respectively. Forced degradation studies showed minor degradation under acid, alkali, oxidation, and thermal conditions. The method was precise (%RSD < 2.0), accurate (recovery 98-102%), robust, and suitable for routine quality control.³²

Parameters	Description
Column Name	Kromasil C18 (5 µm, 150 × 4.6 mm i.d.)
Mobile Phase	0.1% ortho-phosphoric acid (pH 2.7): Acetonitrile (65:35, v/v)
Flow Rate	1.0 mL/min
Detection	Ultraviolet detection at a wavelength of 224 nm
Retention Time	Metformin Hydrochloride: 2.170 min. Ertugliflozin Pidolate: 2.929 min.

Sharmila Donepudi and his co-workers published the paper in the year 2012. The study developed and validated a stability-indicating RP-HPLC method for estimating Canagliflozin in bulk and tablet dosage forms. Chromatographic separation was performed on a Hypersil BDS C18 column (100 × 4.6 mm, 5 µm) with a mobile phase of 0.1% ortho-phosphoric acid buffer and acetonitrile (53:47 v/v) at a flow rate of 1.1 mL/min, detecting Canagliflozin at 240 nm. Retention time was 3.3 min, and the method was linear (R² = 0.9999) in the 75-450 µg/mL range. LOD and LOQ were 0.23 µg/mL and 0.7 µg/mL, respectively. Forced degradation studies revealed significant degradation under alkaline conditions compared to acid, oxidation, thermal, and UV stress. The method was accurate (recovery 99.83-100.27%), precise (%RSD < 2.0), and suitable for routine quality control of Canagliflozin.³³

Parameters	Description
Column Name	Hypersil BDS C18 (5 µm, 100 × 4.6 mm i.d.)
Mobile Phase	A mixture of 0.1% ortho-phosphoric buffer and acetonitrile (53:47 v/v).
Flow Rate	1.1 mL/min.
Detection	Ultraviolet detection at a wavelength of 240 nm.
Retention Time	3.3 min.

Maddu Suma and co-workers published the paper in the year 2014. The study developed and validated a stability-indicating RP-HPLC method for estimating Canagliflozin in tablet dosage form. Chromatographic separation was performed on an ODS column (4.6 × 150 mm, 5 µm) with a mobile phase of water and acetonitrile (55:45 v/v) at a flow rate of 1.0 mL/min, detecting Canagliflozin at 214 nm. Retention time was 2.8 min, and the method was linear (R² = 0.9999) in the 25-150 ppm range. LOD and LOQ were 0.037 µg/mL and 0.112 µg/mL, respectively. Forced degradation studies showed significant degradation under alkaline conditions compared to acid, oxidation, thermal, and UV stress. The method was accurate (recovery 98-102%), precise (%RSD < 2.0), and suitable for routine quality control of Canagliflozin.³⁴

Parameters	Description
Column Name	ODS column (4.6 × 150 mm, 5 µm).
Mobile Phase	Water and acetonitrile (55:45 v/v).
Flow Rate	1.0 mL/min.
Detection	214 nm
Retention Time	2.8 min.

Chhayaben S. Kagarana and co-workers published the paper in the year 2024. The study developed and validated a stability-indicating RP-HPLC method for the simultaneous estimation of Metformin Hydrochloride and Remogliflozin Etabonate in bulk and tablet formulation. Chromatographic separation was performed on a Hypersil BDS C18 column (250 × 4.6 mm, 5 µm) with a mobile phase of Phosphate Buffer (pH 4.0) and Acetonitrile (60:40 v/v) at a flow rate of 1.0 mL/min, detecting the drugs at 226 nm. The retention times were 4.56 min (Metformin Hydrochloride) and 7.79 min (Remogliflozin Etabonate). The method was linear (R² = 0.998 for Metformin Hydrochloride, R² = 0.997 for Remogliflozin Etabonate) in the 20-60 µg/mL and 4-12 µg/mL range, respectively. LOD and LOQ were 0.085 µg/mL and 0.258 µg/mL for Metformin Hydrochloride, and 0.010 µg/mL and 0.030 µg/mL for Remogliflozin Etabonate. Forced degradation studies showed significant degradation under acidic, alkaline, oxidative, thermal, and photolytic conditions. The method was accurate (recovery 99.69-100.28% for Metformin Hydrochloride and 99.52-101.26% for Remogliflozin Etabonate), precise (%RSD < 2.0), and suitable for routine quality control.³⁵

Parameters	Description
Column Name	Hypersil BDS C18 (250 × 4.6 mm, 5 µm).
Mobile Phase	Phosphate Buffer (pH 4.0) and Acetonitrile (60:40 v/v).
Flow Rate	1.0 mL/min.
Detection	226 nm.
Retention Time	Metformin Hydrochloride: 4.56 min. Remogliflozin Etabonate: 7.79 min.

CONCLUSION:

This review compiles and evaluates previously published analytical techniques for the quantification of ertugliflozin in various pharmaceutical and biological matrices. HPLC, particularly RP-HPLC, is the most widely employed method due to its accuracy, precision, and robustness. Numerous studies have developed and validated methods for determining ertugliflozin in bulk drugs and formulations. Additionally, other techniques such as spectrophotometry have been explored.

This study makes a significant contribution by systematically synthesizing previous research on ertugliflozin methodologies. It serves as a valuable resource for researchers and pharmaceutical analysts seeking reliable analytical approaches for quality control and pharmacokinetic investigations.

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Received on 06.04.2025 Revised on 12.05.2025

Accepted on 07.06.2025 Published on 12.07.2025

Available online from July 21, 2025

Asian Journal of Pharmaceutical Analysis. 2025; 15(3):236-242.

DOI: 10.52711/2231-5675.2025.00037

This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License. Creative Commons License.