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Journal of Drug Delivery and Therapeutics

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Open Access Full Text Article                                                   Review Article

Gliptin combinations: A Review on analytical methods 

*Mukthinuthalapati Mathrusri Annapurna and Sathya Sree Guduru 

GITAM School of Pharmacy, GITAM (Deemed to be) University, Visakhapatnam, India

Article Info:

_______________________________________________

Article History:

Received 07 Oct 2024  

Reviewed 09 Nov 2024  

Accepted 02 Dec 2024  

Published 15 Dec 2024  

_______________________________________________

Cite this article as: 

Annapurna MM, Guduru SS, Gliptin combinations: A Review on analytical methods, Journal of Drug Delivery and Therapeutics. 2024; 14(12):214-221 DOI: http://dx.doi.org/10.22270/jddt.v14i12.6935                _______________________________________________

*Address for Correspondence:  

Mukthinuthalapati Mathrusri Annapurna, GITAM School of Pharmacy, GITAM (Deemed to be) University, Visakhapatnam, India

Abstract

_______________________________________________________________________________________________________________

Diabetes mellitus is a metabolic disorder that causes high blood sugar levels. Several classes of drugs are used for the treatment. Gliptins inhibit the dipeptidyl peptidase 4 enzyme that prolongs the secretion of insulin in the pancreas and also improve the insulin secretion in response to increased blood glucose which may lead to improved glucose tolerance. Gliptins is an important class of drugs used for the treatment of diabetes in which many drugs such as Alogliptin, Linagliptin, Teneligliptin, Saxagliptin and Sitagliptin are incorporated by which the blood glucose can be controlled. In the present study the authors have summarized the analytical methods so far developed with the combination of Gliptins for the treatment of diabetes. 

Keywords: Diabetes mellitus, Gliptins combinations, Analytical methods

  

 

 


 

Introduction

Gliptin derivatives are used in the treatment of diabetes and the combination of Gliptins derivatives with other diabetic drugs are also useful in the treatment of diabetes1. Analytical methods such as spectrophotometry, HPLC and LC-MS methods are developed for the combination of Gliptin derivatives with other drugs. Some of the structures of Gliptins were shown in Figure 1.

The liquid chromatographic methods so far developed for the combination of Alogliptin with Glibenclamide2, Pioglitazone3-5 and Metformin hydrochloride6-10; Linagliptin with Metformin HCl11-16, Dapagliflozin17, Empagliflozin18-20 and with Metformin HCl as well as Empagliflozin together21; Saxagliptin with Dapagliflozin22-29, Sitagliptin30, Metformin HCl31-33; Sitagliptin with Metformin34-37, Simvastatin38-40 and Etruglifloxin41-42 were summarized in Table 1.


 

 

image

Saxagliptin (SX): (1S,3S,5S)-2-[(2S)-2-amino-2-(3-hydroxy-1-adamantyl) acetyl]-2-azabicyclo [3.1.0] hexane-3-carbonitrile

image

Sitagliptin (ST): 7-[(3R)-3- amino-1-oxo-4-(2,4,5-trifluorophenyl) butyl]-5,6,7,8-tetrahydro-[3-(trifluoromethyl)-1,2,4- triazolo[4,3-a] pyrazine phosphate (1:1) monohydrate

image

Alogliptin (AL): 2-({6-[(3R)-3-Aminopiperidin-1-yl]-3-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl} methyl) benzonitrile

image

Linagliptin (LN): 8-[(3R)-3-Aminopiperidin-1-yl]-7-(but-2-yn-1-yl)-3-methyl-1-[(4-methylquinazolin-2-yl) methyl]-3,7-dihydro-1H-purine-2,6-dione

undefined

Teneligliptin: ((2S,4S)-4-(4-(3-Methyl-1-phenyl-1H-pyrazol-5-yl) piperazin-1-yl)pyrrolidin-2-yl)(thiazolidin-3-yl) methanone.

Figure 1: Chemical structures of Gliptins

 

Table 1: Liquid chromatographic methods

Combination

Mobile phase (v/v)

λ

(nm)

Column

Linearity

(µg/ml)

Ref

Alogliptin +

Glibenclamide

Acetonitrile: Phosphate buffer (65:35)

240

Waters Xbridge C18

1-5 (AL)

10-50

2

Alogliptin + Pioglitazone

0.1 M Ammonium acetate: methanol (50:50)

248

Zorbax C8 

6.25-18.75 (AL)

11.25-33.75

3

Phosphate buffer: Methanol (45:55)

280

BEH C18

6.25-37.5 (AL)

15-90

4

Acetonitrile: Methanol: Water (30:22:48)

268

Phenomenex C 18 

10-50 (AL)

12-60

5

 

Alogliptin + Metformin hydrochloride

Buffer: Methanol (30:70)

254

Agilent C18

25-150

6

Sodium dihydrogen ortho phosphate: Acetonitrile (70:30)

235

X-Terra C18

7.5- 17.5 (AL)

300-700

7

Acetonitrile: Ammonium Phosphate buffer (70:30)

214

Water C18

6.25-18.75 (AL)

250-750

8

Methanol: 10 mM Potassium dihydrogen phosphate (30:70)

224

Cosmosil C18

4.25-21.25 (AL)

125-625

9

Potassium dihydrogen: Acetonitrile (80:20)

235

SPOLAR C18

5-25 (AL)

50-250

10

Linagliptin + Metformin

Methanol: 0.05 M Potassium dihydrogen orthophosphate (70:30)

267

C18

2-12 (LN)

400-2400

11

Acetonitrile: 0.02M Phosphate buffer (35:65)

225

Water’s X-Bridge C18

1.25-12.5 (LN)

250-2500

12

Acetonitrile: Water: Methanol (25:50:25)

243

C8

5-30 (LN)

10-100

13 

Di-ammonium hydrogen phosphate buffer: Acetonitrile: Methanol (60:20:20)

272

C18

1.25-10 (LN)

250-2000

14

Methanol: Water (0.05% O-phosphoric acid) (50:50)

238

C8 Primesile

1-5 (LN)

 200-1000

15

Methanol: 0.05 M Potassium dihydrogen orthophosphate (70:30)

267

LiChrosphere 100 RP 18e

1-6 (LN)

 200-1200

16

Linagliptin + Dapagliflozin 

Mobile Phase A: Phosphate Buffer: Acetonitrile (900:100)

Mobile Phase B: Phosphate Buffer: Acetonitrile (300:700)

230

X-Bridge C18

6-28 (LN)

12-74

17

Linagliptin + Empagliflozin 

 

Methanol: water (60:40)

270

Waters acquity C18

25-75 (LN) 

50-150  

18

0.1% Perchloric acid: Acetonitrile (60:40)

230

C18

12.5-75 (Both drugs)

19

Potassium dihydrogen: Methanol (70:30)

240

THERMO® C18

50-150 (Both drugs)

20

Linagliptin + Metformin + Empagliflozin

Methanol: 0.1 % OPA Water (30:70)

224

C18 (COSMOSIL)

0.4-2 (LN) 

2-10 (Empagliflozin) 

80-400 (Metformin)

21

Saxagliptin + Dapagliflozin

Acetonitrile: Water (60:40)

248

Xterra RP18

50-250 (SX)

100-500

22

0.1% Ortho phosphoric acid: Acetonitrile (50:50)

254

Eclipse XDB C18

0.01-0.5 (SX)

0.05- 2

23

Buffer: Acetonitrile (53: 47)

230

Xterra C-18

2-14 (Both drugs)

24

Buffer: Acetonitrile (70:30)

221

Symmetry C8

12.5-62.5 (SX)

25-125

25

Methanol: Potassium dihyrogen (45:55)

210

Inertsil-ODS, C18

20-70 (Both drugs)

26

Methanol: 20 mM Phosphate buffer (70:30)

225

Phenomenex Hyperclone C18

2-12 (SX)

4-24

27

Phosphate buffer: Acetonitrile (50:50)

225

XTerra C18

20-60 (SX)

10-120

28

Potassium dihydrogren phosphate Buffer: Acetonitrile (45:55)

247

C18

5-30 (SX)

10-60

29

Saxagliptin + Sitagliptin

Methanol: Water (70:30)

212

255

Cosmosil C18

Develosil ODS

10-50 (SX)

30-70 (ST)

30

Saxagliptin + Metformin HCl

Potassium dihydrogen orthophosphate buffer: Acetonitrile (85:15)

220

BEH C18

10-60 (SX)

100-600

31

0.1M KH2PO4 buffer: Methanol (65:35)

256

C18

50-150 (Both drugs)

32

50mM Sodium dihydrogen phosphate buffer: Methanol (80:20)

242

Kromasil- C18

0.5-3.0 (SX)

50-300

33

Sitagliptin + Metformin

Acetonitrile:  Phosphate (40:60)

257

C8

1-8 (ST) 

10-80

34

Methanol: Water (45:55)

267

C8

10-150 (ST) 

50-450

35

Water: Methanol (60:40)

258

Intersil-BDS C18

20-80 (Both drugs)

36

OPA buffer: Acetonitrile (80:20)

205

AGILENT CN

3-75 (ST)  

25-750

37

Sitagliptin + Simvastatin

Acetonitrile: 10mM Potassium dihydrogen orthophosphate (85:15)

225

Cosmosil C18

20-100 (ST)  

0.4-20.0

38

Methanol: Water (70:30)

253

C8 (Qualisil BDS)

20-150 (ST) 

8-60

39

Acetonitrile: methanol:10 mM Phosphate buffer (65:25:10)

250

Hi-Q Sil C18

100-600 (ST) 

20-120

40

Sitagliptin + Etruglifloxin

Phosphate buffer: Acetonitrile (45:55)

260

Discovery C18

25-150 (ST) 

3.75-22.5

41

OPA 0.2: Acetonitrile (60:40)

250

Waters RP-C18 

 216.50-649.50 (ST) 32.50-97.50

42

 

The spectrophotometric methods developed for the combination of Alogliptin with Pioglitazone hydrochloride43 and Metformin hydrochloride44-45; Linagliptin with Metformin HCl46-48, Empagliflozin49-50; Saxagliptin with Dapagliflozin51-53; Sitagliptin with Metformin54, Simvastatin55 were summarized in Table 2.

Table 2: Spectrophotometric methods

Drug

Reagent

Linearity (µg/ml)

λmax (nm)

Ref

Alogliptin benzoate + Pioglitazone hydrochloride

Methanol

Method A: Ratio difference spectroscopic method

Method B: First derivative of ratio spectra method

Method C: Area under curve method

0.5-5 (AL)

1.8-18

288-291 (AL)

236 -245

290 (AL)

276.8

276 ± 10 (AL)

267.8 ± 10

43

Alogliptin+

Metformin hydrochloride

Methanol

 

5–25 (AL)

4–20

231(AL)

276

44

Methanol

Method A: Simultaneous equation method

Method B: Absorption ratio method

0.5-2.5 

5-25

277 (AL)

232 (Both methods)

45

Linagliptin+ Metformin

Distilled water

10-40 (LN)

2-14

294.4 (LN)

230.4

46

Inference with no excipients and diluents

1-11 (LN)

3-13

227 (LN)

232

47

Methanol: water (40:60)

3-11 (Both drugs)

295 (LN)

234

48

Linagliptin+ Empagliflozin

Inference with no excipients and diluents

5-80 (Both drugs)

293 (LN)

276

49

2M Ammonium acetate: 2M Sodium citrate (50:50)

5-25 (LN)

10-50

294 (LN) 

 270

50

Saxagliptin+ Dapagliflozin

10ml Methanol

2-10 (SX)

4-20

224 (SX)

274

51

Phosphate buffer

5-25 (Both drugs)

222 (SX)

276

52

Method 1: Water

Method 2: Phosphate buffer

1-10 (Both drugs)

222 (SX)

274

53

Sitagliptin+ Metformin

Distilled water

Method A: Absorption Maxima Method

Method B: Area under Curve Method

25-225 (ST)

2-12

266 (ST)

232

244-279 (ST)

222-240

54

Sitagliptin+ Simvastatin

Methanol: Water (90:10)

10-50 (ST)

5-25

267 (ST)

238

55

 

The Liquid chromatography-mass spectrophotometric methods so far developed for the combination of Alogliptin with Voglibose56 and Metformin hydrochloride57; Linagliptin with Metformin HCl58 and Empagliflozin59-60; Saxagliptin with Dapagliflozin61-63 were summarized in Table 3.

Table 3: Liquid chromatography-Mass spectrophotometric methods

Drug

Mobile Phase (v/v)

Linearity (ng/ml)

Ref

Alogliptin+ Voglibose

5mM Ammonium formate: Acetonitrile (50:50)

5.09-509 (AL)

2.03-203

56

Alogliptin+ Metformin

Acetonitrile: 0.2% Formic acid

5- 400 (AL)

 25-2000

57

Linagliptin+ Metformin

Methanol: 10 mM Ammonium formate buffer (95:5)

0.25-10 (LN)

25-2000 

58

Linagliptin+ Empagliflozin

0.1 % aq. Formic acid: Acetonitrile (50:50)

25 - 800 (LN)

50 - 1600 

59

2 mM Ammonium acetate buffer: Acetonitrile

0.01–10

60

Saxagliptin+ Dapagliflozin

0.1% Formic acid: Acetonitrile (25:75)

2-2000 (SX)

0.5-1500

61

10 mM Ammonium acetate: Methanol (20:80)

50-10000 (pg/mL) 

(Both drugs)

62

Acetonitrile: 5 mM Ammonium acetate buffer (70:30).

0.502-227 (SX) 

0.103-76.402 

63

 


 

Conclusion

The present study represents a detailed review of the analytical methods so far developed for the Gliptin combinations class of drugs such as Alogliptin, Linagliptin, Sitagliptin and Saxagliptin in pharmaceutical formulations as well as biological fluids.

Consent and ethical Approval: It is not applicable.

Conflict of Interest: None.

Funding Source: None.

Author Contributions: All    authors   have   equal contribution in the preparation of manuscript and compilation.

Source of Support: Nil.

Informed Consent Statement: Not applicable. 

Data Availability Statement: The data supporting in this paper are available in the cited references.

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