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Abstract

Erectile dysfunction (ED) is a common and distressing complication in men with type 2 diabetes mellitus (T2DM), primarily caused by endothelial dysfunction, impaired nitric oxide signaling, and metabolic abnormalities. Phosphodiesterase-5 inhibitors such as tadalafil are widely prescribed for ED; however, their effectiveness may be reduced in diabetic patients due to underlying vascular damage. Dapagliflozin, a sodium–glucose co-transporter-2 (SGLT2) inhibitor used for glycemic control, has demonstrated additional benefits including improvement in endothelial function, blood pressure reduction, and enhanced vascular health. These effects suggest a potential supportive role of dapagliflozin in improving erectile function and augmenting the therapeutic response to tadalafil in diabetic individuals. Alongside therapeutic considerations, accurate and reliable analytical methods are essential for quality control and regulatory compliance of these drugs. This review provides a comprehensive overview of the physicochemical properties, pharmacological significance, and reported analytical methods for dapagliflozin and tadalafil, with emphasis on reverse-phase high-performance liquid chromatography (RP-HPLC). Various chromatographic conditions, validation parameters, and official pharmacopoeia methods are discussed. Overall, this review serves as a valuable reference for pharmaceutical analysts and researchers involved in method development and quality assessment of these clinically important agents.

Keywords

Dapagliflozin, Tadalafil, erectile dysfunction; type 2 diabetes mellitus, RP-HPLC, analytical method development

Introduction

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Erectile dysfunction frequently endures despite proper glycaemic management, suggesting the necessity for treatment strategies that address the disease's vascular and metabolic components. The progressive metabolic disease known as type 2 diabetes mellitus (T2DM) has long-term consequences that seriously lower quality of life. Among these problems, endothelial dysfunction, reduced nitric oxide bioavailability, autonomic neuropathy, and vascular damage from long-term hyperglycaemia are the main causes of erectile dysfunction (ED), which is extremely common in male T2DM patients.

Dapagliflozin (DAPA)

By decreasing renal glucose reabsorption, dapagliflozin, a specific sodium–glucose cotransporter-2 (SGLT2) inhibitor, increases urine glucose excretion and improves glycaemic management without requiring insulin secretion. In addition to its antihyperglycemic actions, dapagliflozin has been shown to promote vascular health, reduce oxidative stress, and improve endothelial function. These pleiotropic effects raise the possibility that dapagliflozin may help reduce erectile dysfunction and other vascular problems associated with diabetes. Dapagliflozin may improve erectile function measures in men with type 2 diabetes, according to recent clinical evidence, potentially via increasing penile blood flow and endothelial reactivity.

Tadalafil (TADA)

One common first-line treatment for erectile dysfunction is tadalafil, a phosphodiesterase type-5 (PDE-5) inhibitor. It works by preventing the breakdown of cyclic guanosine monophosphate (cGMP), which improves erectile response and nitric oxide-mediated vasodilation in the corpus cavernosum. However, underlying endothelial dysfunction and decreased nitric oxide signalling may restrict the effectiveness of tadalafil as monotherapy in T2DM patients, requiring complementary therapeutic options to maximize clinical outcomes.

CAUSES OF ERECTILE DYSFUNCTION [2]

Erectile dysfunction is a multifactorial disorder resulting from disturbances in vascular, neurological, hormonal, psychological or endothelial function. The major causes include:

  • Vascular causes: Atherosclerosis, cardiovascular disease and hypertension leading to reduced penile blood flow.
  • Metabolic disorders: Diabetes mellitus and metabolic syndrome causing endothelial dysfunction, oxidative stress and neuropathy.
  • Endocrine causes: Hypogonadism (low testosterone), thyroid disorders and other hormonal imbalances.
  • Neurological causes: Stroke, spinal cord injury, multiple sclerosis and peripheral neuropathy affecting erectile nerve pathways.
  • Drug-induced causes: Antihypertensives, antidepressants, antipsychotics, opioids and recreational drugs.
  • Psychological causes: Depression, anxiety, stress and performance anxiety.
  • Lifestyle factors: Smoking, obesity, alcohol abuse and sedentary lifestyle.

PATHOPHYSIOLOGY

Combined Pathophysiology of Tadalafil and Dapagliflozin

In type 2 diabetes mellitus, chronic hyperglycaemia leads to oxidative stress, endothelial dysfunction and reduced nitric oxide (NO) availability, resulting in impaired cyclic guanosine monophosphate (cGMP) signalling and erectile dysfunction. Dapagliflozin improves glycaemic control by inhibiting renal sodium–glucose cotransporter-2, thereby reducing hyperglycaemia-induced oxidative stress and restoring endothelial function and NO bioavailability. Tadalafil inhibits phosphodiesterase-5, preventing cGMP degradation and enhancing NO-mediated smooth muscle relaxation in the corpus cavernosum. The combined use of dapagliflozin and tadalafil therefore targets both the underlying metabolic abnormality and the impaired NO–cGMP pathway, producing a synergistic improvement in penile haemodynamic and erectile function in patients with type 2 diabetes mellitus.

MECHANISM OF ACTION (MOA) [3]

The management of erectile dysfunction (ED) aims to restore erectile function, improve sexual satisfaction and address underlying pathophysiological factors such as endothelial dysfunction, metabolic abnormalities and impaired nitric oxide signalling. Current treatment strategies include pharmacological therapy as the primary approach, along with lifestyle modification and management of comorbid conditions.

Role of Tadalafil in Erectile Dysfunction

Phosphodiesterase type-5 inhibitors (PDE-5 inhibitors) represent the first-line pharmacological treatment for erectile dysfunction. Tadalafil is a long-acting PDE-5 inhibitor that enhances erectile function by inhibiting the degradation of cyclic guanosine monophosphate (cGMP), thereby potentiating nitric oxide–mediated smooth muscle relaxation in the corpus cavernosum. Compared to other PDE-5 inhibitors, tadalafil offers a prolonged duration of action, allowing flexible dosing regimens including on-demand and once-daily administration. Tadalafil is effective in a wide range of patients; however, its therapeutic response may be reduced in individuals with diabetes mellitus due to underlying endothelial dysfunction and impaired nitric oxide bioavailability.

Role of Dapagliflozin in Erectile Dysfunction

Dapagliflozin, a sodium-glucose cotransporter-2 (SGLT-2) inhibitor, is primarily indicated for the management of type 2 diabetes mellitus. Emerging evidence suggests that dapagliflozin may contribute to improvement in erectile dysfunction by targeting metabolic and vascular abnormalities associated with diabetes. By reducing hyperglycaemia, oxidative stress and inflammation, dapagliflozin improves endothelial function and enhances nitric oxide availability. Although not a conventional erectile dysfunction drug, dapagliflozin represents a novel adjunctive therapeutic option in diabetic patients with erectile dysfunction by addressing the underlying disease pathology rather than providing only symptomatic relief.

DRUG PROFILE [4,5,6]

Tab.1 Drug profile of Dapagliflozin and Tadalafil

Drug

Dapagliflozin

Tadalafil

Chemical Structure

IUPAC Name

2-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-6-(hydroxymethyl)oxane-3,4,5-triol

(6R,12aR)-2,3,6,7,12,12a-Hexahydro-2-methyl-6-(3,4-methylene dioxyphenyl) pyrazino (1′,2′:1,6) pyrido (3,4-b) indole-1,4-dione

Molecular Formula

C21H25ClO6

C22H19N3O4

Molecular Weight

408.88 g/mol

389.404 g/mol

Solubility

DMSO, dimethyl formamide and ethanol, methanol

Very low soluble in Water

Very slightly Soluble in Methanol

pKa

13.23

13.1

Log p

2.7

2.36

Melting Point

65-70°C

301- 302°C

Therapeutic Uses

Oral Hypoglycaemic Agent

To treat Erectile Dysfunction (ED)

LITERATURE REVIEW OF DAPAGLIFLOZIN

There are no official methods available for Dapagliflozin in Pharmacopoeia

Tab. 2 UV spectrophotometric method of Dapagliflozin

Sr. No.

Matrix

Solvent

Detection Wavelength (nm)

Ref. No.

1

Bulk

Ethanol

278

07

2

Tablet

Methanol

224

08

3

Bulk & Tablet

Methanol

220

09

4

Bulk & Tablet

Methanol

228

10

5

API

Ethanol

237

11

6

Bulk & Tablet

Methanol

225

12

Reported HPLC method of Dapagliflozin

Tab. 3. HPLC method of Dapagliflozin

Sr.

No.

Matrix

S.P.

Solvent System

Detection Wavelength

(nm)

Flow

Rate

(mL/min)

Retention Time

(min)

LOD

(µg/mL)

LOQ

(µg/mL)

Ref. No.

1

Tablet

Zorobax Eclipse Plus Phenyl Hexyl

(25×0.46cm, 5µm)

Buffer: Methanol: ACN

(40:35:25 % Vol/Vol)

267

1.0

8.99

-

-

13

2

Synthetic

Mixture

C18

(25×0.46cm, 5µm)

ACN: Methanol: NH4CH3CO2 Buffer (pH-5.5)

(60:20:20 %Vol/Vol/Vol)

268

1

8.328

0.78

2.36

14

3

Tablet

Shimadzu C18

(15×0.46cm, 5 µm)

Buffer: ACN

(65:35 % Vol/Vol)

205

0.8

6.986

-

-

15

4

Tablet

Princeton C18

(25×0.46cm, 5µm)

ACN: 0.1%TEA

(50:50 Vol/Vol)

254.6

1

-

-

-

16

5

Tablet

C18

(15×0.46cm, 2.5 µm)

ACN: 0.05% H3PO4

(80:20 % Vol/Vol)

pH 6.5 With 0.1% TEA

286

1

3.044

2.11

6.40

17

6

Tablet

Cosmosil C18

(25×0.46cm, 5 µm)

Methanol: Buffer (85:15 Vol/Vol) With Adjusted pH 3 By KH2PO4

224

0.9

4.365

0.8076

0.2447

18

7

Tablet

Princeton C18

(25×0.46cm, 5 µm)

ACN: 0.1% TEA

(pH-5.0)

(50:50 Vol/Vol)

224

1

5.163

2.1

6.39

19

8

Bulk & Tablet

Phenomenex C18

(25×0.46cm, 5 µm)

Water: Methanol (50:50 Vol/Vol)

230

1

3.338

263000

ppb

324000

ppb

20

9

Tablet

Hypersil BDS C18

(25×0.46cm, 5 µm)

ACN: Water (90:10 Vol/Vol)

245

1

7.82

0.065

0.196

21

10

Tablet

Agilent Poroshell 120 EC- C18

(25×0.46cm, 5 µm)

Water: ACN

(30:70 Vol/Vol)

225

0.9

10.020

0.25

1.6

22

11

Synthetic

Mixture

Shimadzu C18,

(25×0.46cm, 5 µm)

ACN: Methanol: Buffer (pH 4)

(35:35:30 Vol/Vol/Vol)

236

1

4.0

0.288

0.951

23

12

Tablet

Zorbax Eclipse Plus, Agilent Technology (15×0.46cm, 5μm)

Water: Methanol (25:75 Vol/Vol)

230

1

3.1

2.5

10.00

24

13

Tablet

C18 Column

(25×0.46cm, 5 µm)

ACN:0.1% H3PO4

(50:50 Vol/Vol)

210

0.98

3.45

0.09

0.27

25

14

Tablet

Hypersil BDS C18 (25×0.46cm, 5 µm)

Methanol: ACN (60:40 Vol/Vol)

215

1.5

-

-

-

26

15

Tablet

Phenomenex C18

(15×0.46cm, 5µm)

Buffer: ACN: Methanol

(30:5:65 Vol/Vol/Vol)

(pH 3.5)

249

1.2

3.238

0.084

0.254

27

16

Tablet

C18

(15×0.46cm, 5µm)

2% GAA: ACN (85:15 Vol/Vol)

230

1

1.979

0.18

-

28

17

Synthetic

Mixture

Gemini, C18,

(25×0.46cm, 5µm)

Methanol: 20 mM CH5NO2 (70:30 Vol/Vol)

225

1

4.20

0.947

2.869

29

18

 

Bulk

ODS C18

(25×0.46cm, 5μm)

ACN: HPLC Water

(30:70 Vol/Vol)

230

1

-

0.138

0.417

30

19

Bulk Drug

Inertsil C18

(15×0.46cm, 5 µm)

ACN: 10 mM KH2PO4 pH 6.5 By TEA (75:25 %Vol/Vol)

214

1

11.411

0.35

1.06

31

20

Bulk & Tablet

Agilent 5 TC C18

(15×0.46cm, 4µm)

Water: Methanol

(30:70 Vol/Vol).

224

1.2

6.5

-

-

32

21

Bulk & Tablet

Phenomenex Luna® LC C18

(15×0.46cm, 5µm)

ACN: Water

(65:35 Vol/Vol)

225

1.0

2.2

0.306

0.929

33

22

Bulk & Tablet

Zorbax Eclipse Plus C8

(15×0.46cm, 5µm)

Buffer (pH 7.6) Tris: Methanol

(60:40 Vol/Vol)

224

1

1.467

0.207

0.693

34

23

Tablet

Inertsil ODS-3V

(15×0.46cm, 5μm)

50% ACN :50% Water (50:50 Vol/Vol.)

223

1.00

8

0.257

0.778

35

24

Bulk & Tablet

Agilent C18

(15×0.46cm, 5 µm)

ACN: K2HPO4 With pH-6.5 By H3PO4

(40:60 %Vol/Vol)

222

1.00

3.067

5.14

15.6

36

25

Tablet

ZORBAX (C18)

(25×0.46cm, 5 µm)

Phosphate Buffer: ACN: Methanol

(55:40:05 Vol/Vol/Vol)

225

1.00

2.12

-

-

37

26

Tablet

C18 Column

(25×0.46cm, 5 µm)

Methanol: Water (75:25 % Vol/Vol)

pH-3 Adjusted With 0.05 % H3PO4

233

1.00

5.099

0.06

0.1855

38

27

Tablet

X-Bridge C18,

(25×0.46cm, 5μm)

Mobile Phase A: Phosphate Buffer: ACN (900:100 Vol/Vol)

Mobile Phase B: Phosphate Buffer: ACN

(300:700 Vol/Vol)

230

1.00

15.639

-

-

39

28

Tablet

Develosil ODS HG-5 C18

(15×0.46cm, 5µm)

Phosphate Buffer: ACN

(80:20 Vol/Vol)

292

1.00

3.545

0.09

0.27

40

29

Tablet

C18 Inertsil ODS

(15×0.46cm, 5μm)

Phosphate Buffer: ACN

(55:45 Vol/Vol),

pH 4.0 Adjusted By GAA

220

0.8

3.15µ6

-

-

41

30

Tablet

C18 Thermoquest, Hypersil

(25×0.46 cm, 5 µm)

10 mM NH4CH3CO2 Buffer pH 4: Methanol: ACN

(30:65:05 Vol/Vol/Vol)

227

0.8

5.988

1.121

3.396

42

31

Tablet

Inertsil ODS 3V

(25×0.46cm, 5µm)

ACN: H?PO? (0.1%) (50:50 Vol/Vol)

235

1.2

4.683

-

-

43

32

Tablet

Shim-Pack C18 RP

(25×0.46cm, 5 µm)

Water: Ethanol

(40 :60, % Vol/Vol)

pH 3.0.

212

1.00

3.85

0.0223

0.06693

44

33

Tablet

Agilent Zorbax SB-Aq

(25×0.46cm, 5 µm)

Water: ACN

(50:50 % Vol/Vol)

258

1

6.45

23.44

2.62

45

34

Drug

YMC Pack Pro C18,

(25×0.46cm, 5 µm)

ACN: H?PO?

(50:50 Vol/Vol)

225

0.8

21

1.9

0.8

46

35

Bulk And Tablet

Hypersil C18

(25×0.46cm, 5 µm)

ACN: Water (90:10 Vol/Vol)

Adjusting pH 3 Using NH4CH3CO2

244

1

3.01

0.052

0.15

47

36

Tablet

Cosmosil C18

(25×0.46cm, 5 µm)

Methanol: KH2PO4 Buffer With pH 3.0 (80:20 %Vol/Vol)

228

0.9

3.6

0.052

0.158

48

37

Bulk & Tablet

Develosil ODS HG-5 RP C18,

(15×0.46cm, 5µm)

Methanol: Phosphate Buffer

(0.02M, pH-3.6)

(45:55 % Vol/Vol)

255

1.0

3.29

5.004

15.164

49

38

Bulk & Tablet

Symmetry C18,

(25×0.46cm, 5 µm)

Methanol: ACN: H?PO?

(75:25:05 Vol/Vol/Vol)

246

1.0

2.797

0.04

0.12

50

39

Bulk & Tablet

Sunsil C18

(15×0.45cm, 5µm)

Methanol: Water

(85:15 Vol/Vol)

225

1.0

2.47

0.011

0.034

51

40

Bulk & Tablet

Lichrospher 100 RP-18e (25×0.46cm, 5 µm)

0.01% Formic Acid: ACN

(30:70 Vol/Vol)

219

0.8

3.1

0.06

0.21

52

41

Bulk & Tablet

Prontosil C18

(25×0.46cm, 5 µm)

20mM KH2PO4: ACN (pH 3.5 With H3PO4)

(30:70 Vol/Vol)

275

1

-

0.018

0.050

53

42

API & Impurities

X-Bridge Phenyl C18, (25×0.46cm, 5 µm)

Aq. Trifluoracetic Acid: ACN

(80:20 % Vol/Vol)

210

1

7.389

0.0000627 ppm

0.000619 ppm

54

43

Bulk & Tablet

Agilent C18

(25×0.46cm, 5 µm)

Methanol: 0.05 % H3PO4 Buffer

(70:30 Vol/Vol)

233

1.00

5.576

1.1942

3.617

55

44

Tablet

Zorbax Eclipse Plus C18

(25×0.46cm, 5 µm)

10 mM NH4CH3CO2 Buffer: Water: Methanol: ACN

(40:50:10 Vol/Vol/Vol)

224

0.6

12.7

0.50

1.56

56

45

Bulk & Synthetic Mixture

Phenomenex Luna C18 (25×0.46cm, 5 µm)

ACN: Water

(75:25 % Vol/Vol)

285

1.00

5.4

3.7

11.4

57

46

Bulk & Tablet

C18 Thermo

(25×0.46cm, 5 µm)

Methanol: 0.1 % H3PO4

(60:40 Vol/Vol)

220

1.00

7.30

-

-

58

47

Tablet

Zorbax Eclips XDB C18 (15x 0.46cm, 5µm)

Buffer: ACN: Methanol

(60:37:03 % Vol/Vol).

220

1

5.99

-

-

59

LITERATURE REVIEW OF TADALAFIL

Tab. 4 Official Method of Tadalafil

Sr.

No.

Official Method

Matrix

S.P.

Solvent System

Detection Wavelength

(nm)

Flow

Rate

(mL/min)

Ref. No.

1.

IP 2018, Volume 2

Bulk

A stainless-steel column 25 cm x 4.6 mm packed with Silica gel AD for chiral separation.

Equal volumes of hexane and isopropyl alcohol

222

0.75

60

2.

IP 2018, Volume 2

Tablet

A stainless-steel column 5 cm x 4.6 mm packed octadecylsilane bonded to porous silica (3.5 μm)

A mixture of equal

volumes of methanol and water

225

2

61

3.

USP 2019, Volume 2

Bulk

4.6 mm × 25 cm; 5 μm packing L7

Acetonitrile: solution (Add 1 ml of trifluoroacetic acid to 1L of water

(45:55)

285

1.5

62

4.

USP 2019, Volume 2

Tablet

4.6 mm × 25 cm; 3.5 μm packing L7

Methanol: Water (50:50 v/v)

285

2

63

Tab. 5 UV spectrophotometric method of Tadalafil

Sr. No.

Matrix

Solvent

Detection Wavelength (nm)

Ref. No.

1

Bulk & Tablet

Methanol

284

64

2

Bulk & Tablet

Methanol: Water (80:20)

284.5

65

3

Bulk & Tablet

DMSO

285.6

66

4

Bulk

Methanol

284.40

67

5

Bulk & Tablet

Methanol

235

68

6

Bulk & Tablet

Methanol

284

69

Reported HPLC method of Tadalafil

Tab. 6 HPLC method of Tadalafil

Sr.

No.

Matrix

S.P.

Solvent System

Detection Wavelength

(nm)

Flow

Rate

(mL/ min)

Retention Time

(min)

LOD

(µg/ mL)

LOQ

(µg/ mL)

Ref. No.

1.

Tablet

Supelco C18 column (25cm x 4.6 mm; 5 µm)

Methanol: Water: Triethylamine (60:38:2 v/v/v) pH adjusted to 4.0 with dilute phosphoric acid

220

1.3

3.6

0.02811

0.09345

70

2.

Bulk and Tablet

Agilent Eclipse XDB C18 column (150 mm × 4.6 mm, 5 μ)

Buffer (potassium dihydrogen orthophosphate) and acetonitrile in the ration of 50:50 v/v

285

1.2

3.181

0.03

0.09

71

3.

Tablet

Agilent Zorbax SB C8 column (50 ×4.6 mm, 1.8 μm)

0.030M of ammonium formate (adjusted to pH 3.0 with formic acid) and acetonitrile in the ratio 70:30, v/v

230

1.3

5.067

0.1

-

72

4.

Tablet

Agilent eclipse C18 column (4.6 x 250mm, 5um)

Phosphate buffer pH 4.0: Acetonitrile (50:50 v/v)

284

1.0

6

-

-

73

5.

Tablet

Hypersil GOLD C18 column (150 mm × 4.6 mm internal diameter, 5 μm particle size)

Methanol: Water: Acetonitrile (40:40:20 v/v/v)

260

0.5

7.10

0.12

0.36

74

6.

Tablet

Water Symmetry C18 (150 x 4.6 mm)

50mM Phosphate buffer (pH 6.0) : Acetonitrile (65:35 v/v)

285

1.0

10.08

0.039

0.129

75

7.

Tablet

Phenomexgemini C18 (150 mm, 4.6 mm, 5μm)

Methanol: 10 mM ammonium formate (74.1: 25.9, v/v)

260

0.94

4

-

-

76

CONCLUSION

Dapagliflozin and tadalafil represent an effective therapeutic approach for managing erectile dysfunction in patients with type 2 diabetes mellitus by improving metabolic and vascular function. This review summarizes the pharmacological relevance and the wide range of reported RP-HPLC methods for their estimation in bulk and pharmaceutical dosage forms. The compiled analytical information provides a useful reference for method selection and future analytical method development.

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Bariya Siddhraj
Corresponding author

Sigma Institute of Pharmacy, Sigma University, Vadodara

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Patil Priyanka
Co-author

Sigma Institute of Pharmacy, Sigma University, Vadodara

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Dalwadi Mitali
Co-author

Sigma Institute of Pharmacy, Sigma University, Vadodara

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Limbachiya Harsh
Co-author

Sigma Institute of Pharmacy, Sigma University, Vadodara

Bariya Siddhraj, Patil Priyanka, Dalwadi Mitali, Limbachiya Harsh, A Comprehensive Review on Dapagliflozin and Tadalafil: Role in Erectile Disfunction, Int. J. of Pharm. Sci., 2026, Vol 4, Issue 1, 2636-2651. https://doi.org/10.5281/zenodo.18351369

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