Review of Analytical Method for Quality Assurance and Estimation
of Antidiabetic drugs in Pharmaceutical Formulation
Siddhesh R.
Rane*, Patel M. Siddik, Mohammad Saqib, Gulam Javed Khan
JIIU’s Ali Allana College of
Pharmacy, Akkalkuwa Dist.: Nandurbar.
*Correspondence: siddheshrr29502@gmail.com;
DOI: https://doi.org/10.71431/IJRPAS.2026.5405
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Article
Information
|
|
Abstract
|
|
Review Article
Received: 17/04/2026
Accepted: 26/04/2026
Published:30/04/2026
Keywords
RP-HPLC,
ICH Guidelines,
Method validation,
Sitagliptin,
Linagliptin.
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|
Type
2 Diabetes mellitus is a chronic metabolic condition known as hyperglycemia
due to insulin deficiency. Dipeptidyl Peptidase -4 (DPP-4) inhibitor, or
gliptin such as sitagliptin, linagliptin, vidagliptin, etc. it use as oral
therapies that stabilize blood glucose by enhancing incretin hormone
activity.
This
study evaluated different analytical method for identification and quality
assurance of gliptin in bulk and pharmaceutical dosage forms. A comparative
analysis of techniques, including UV-visible spectrophotometry, RP-HPLC,
HPTLC, LC-MS was conducted. Each approach can show critical performance such
as linearity, mobile phase, sensitivity, maximum absorbance wavelength and
sensitivity.
Adherence
to ICH and GMP guideline is central to review, it shows the method validation
to guarantee drug potency and purity. The result shows the UV-visible
spectroscopy provide rapid, cost effective for basic testing, RP-HPLC remain
best for routine quality control due to its exceptional precision and
resolution. This synthesis offer a technical roadmap for selecting optimal
platform for gliptin analysis in modern pharmaceutical environment.
|
INTRODUCTION
The
characteristic of type 2 diabetes mellitus (T2DM), a chronic, progressive
metabolic disease that affects people all over the world, is hyperglycemia
caused by insulin resistance or inadequate insulin production [2].
Effective management of type 2 diabetes is necessary to avoid long-term
microvascular and macrovascular consequences. Dipeptidyl Peptidase-4 (DPP-4)
inhibitors, often known as gliptins, were a significant advancement in the oral
treatment of this condition [1]. Gliptins stand a distinct class
of incretin-based treatments that are increasingly being used [1],
either alone or in conjunction with other anti-diabetic medications such
as metformin [1, 2]. Following Sitagliptin (2006), the
FDA authorized Vildagliptin, Saxagliptin, Alogliptin, and Linagliptin [1, 3].
Gliptins
therapeutic action is attributed to their particular inhibition of the DPP-4
enzyme [3]. This enzyme spontaneously breaks
down and inactivates the incretin hormones glucagon-like peptide-1 (GLP-1) and
glucose-dependent insulin tropic polypeptide (GIP) [1, 2].
Gliptins increase the amounts of
circulating, active incretins by blocking DPP-4 [2, 3].
As a result, the pancreatic beta cells secrete more glucose-dependent
insulin while alpha cells generate less glucagon [1, 3].
This enhances postprandial and fasting glucose control in clinical
settings with a weight-neutral profile and minimal risk of hypoglycemia [1].
The
gliptin family's pharmaceutical formulations and bulk medicinal ingredients
need stringent quality control due to their extensive use and commercial
importance [2, 3]. To
guarantee the identification, purity, and concentration of these chemicals,
trustworthy analytical techniques must be developed and validated [4, 3].
Gliptins may be evaluated using a variety of advanced analytical methods
in pharmacological dosage forms and biological samples, both alone and in
fixed-dose combinations with drugs such as metformin [2].
“Ultraviolet-visible (UV)”, “Reversed-Phase High Performance Liquid
Chromatography (RP-HPLC)”, and “High-Performance Thin-Layer Chromatography
(HPTLC)” Two commonly utilized techniques are “Spectrophotometry and Liquid
Chromatography-Mass Spectrometry (LC-MS/MS).”
Physiochemical
Properties of Drug
Table 1. Physiochemical Properties of Drug
|
Drug
|
Sitagliptin [5]
|
Linagliptin [6]
|
Tenegliptin [7]
|
Trelagliptin [8]
|
Saxagliptin [9]
|
|
Category
|
Anti-diabetic drug
|
|
Formula
|
C16H15F6N5O
|
C25H28N8O2
|
C22H30N6OS
|
C18H20FN5O2
|
C18H25N3O2
|
|
pKa value
|
8.78
|
|
8.7
|
14.7
|
7.9 (basic); 14.74 (acidic)
|
|
Melting point
|
110-120 °C
|
190-207 °C
|
209
- 211°C
|
95–100 °C
|
103–107 °C
|
|
Molecular weight
|
407.31g/mol
|
472.54g/mol
|
426.58g/mol
|
357.39g/mol
|
315.42 g/mol
|
|
C.A.S No.
|
486460-32-6
|
668270-12-0
|
760937-92-6
|
865759-25-7
|
361442-04-8
|
|
Solublity
|
Solublity in water and N, N dimethyl formamide, and soluble in MeOH,
and insoluble in isopropanol.
|
Solublity in ethanol and methanol, but only very weakly soluble in
acetone and isopropanol.
|
Meltable in DMSO, DMF, and
ethanol
|
Soluble in water, DMSO and
methanol
|
Soluble in water , methanol,
ethanol and polyethylene glycol 400
|
|
Palitative uses
|
It guides a glucose-dependent rise in insulin and
a fall in glucagon.
|
Management of Type 2 diabetes to increase blood
sugar regulation.
|
A hypoglycemic inhibitor of DPP-4.
|
Trelagliptin use as once-weakly for treatment of
diabetes, it has long acting DPP-4 inhibitor
|
Saxagliptin main use to enhance glycemic control
in the cure of type 2 diabetes mellitus.
|
Table 2. Physiochemical Properties of Drug
|
Drug
|
Alogliptin [10]
|
Vildagliptin [11]
|
|
Category
|
Anti-diabetic
drug
|
|
Formula
|
C₁₈H₂₁N₅O₂
|
C17H25N3O2
|
|
pKa
value
|
8.8
|
14.7
|
|
Melting
point
|
127 - 129°C
|
149-155 °C
|
|
Molecular
weight
|
339.39
g/mol
|
303.4 g/mol
|
|
C.A.S
No.
|
850649-61-5
|
27901-16-5
|
|
Solublity
|
Slightly
solublity in ethanol; soluble in dimethylsulfoxide, water and methanol
|
Fusible
in dimethyl formamide and ethanol
|
|
Palitative
uses
|
It is a drug that helps shrink
blood sugar levels in order to manage type 2 diabetes.
|
It stops the breakdown of
peptides that resemble glucagon by specifically inhibiting the peptidyl
enzyme.
|
Structure
of Drug:
Figure 1: Alogliptin Figure 2: Vildagliptin Figure 3:
Saxagliptin
Figure 5: Sitagliptin
Figure
6: Linagliptin
Figure 7: Tenegliptin
Figure
8: Trelagliptin
Establishment
of Analytical Techniques for Antidibetic Medication:
To
ascertain drug concentration, dangerous chemical levels, and medicine stability
in pharmaceutical products, medical analysts employ analytical procedures.
Pharmacokinetic investigations require these techniques to evaluate medicines
and their metabolites in bodily fluids. Because polypharmacy is important in
the management of individuals with diabetes, drug analysis becomes even more
important. Analysts require analytical instrument ti monitor a variety of
component for mutually drug study in biological samples and drug formulation
testing [12].
Table 3. UV- Spectrometric Method for Following Drug
|
API
|
Technique
|
λ
max
(nm)
|
Mobile
Phase
|
Ref.
|
|
Sitagliptin
|
UV
Visible Spectrophotometric Method
|
267
|
Methanol
|
[13]
|
|
Linagliptin
|
UV Visible Spectrophotometric
Method
|
407
|
Methanol and
Distilled Water
|
[14]
|
|
Tenegliptin
|
UV
Visible Spectrophotometric Method
|
233
|
Water (Diluent)
|
[15]
|
|
Trelagliptin
|
UV Visible
Spectrophotometric Method
|
274
|
|
[16]
|
|
Saxagliptin
|
UV
Visible Spectrophotometric Method
|
212
|
Water [Diluent]
|
[17]
|
|
Alogliptin
|
UV Visible
Spectrophotometric Method
|
277
|
Methanol &
Water
|
[18]
|
|
Vildagliptin
|
UV
Visible Spectrophotometric Method
|
210
|
Water, 0.1N HCL, or Phosphate buffer of pH 7.4
|
[19]
|
RP-
HPLC and HPLC Spectometric Metod for following Drug:
1.
Sitagliptin
|
Compound
|
Combination drug
|
Technique used
|
Column
|
Mobile Phase
|
λ max
|
Flow (mL/min)
|
Elution Time
|
Ref.
|
|
Sitagliptin
|
Simvastatin
|
RP-HPLC
|
C8 Qualisil BDS
|
70:30 v/v Methanol : Water w/ 0.2% n-heptane sulfonic acid
|
253 nm
|
1.0 mL/min
|
4.3 min
|
[20]
|
|
Sitagliptin Phosphate
|
Repaglinide
|
RP-HPLC
|
RP-18
|
65:35
v/v Acetonitrile : Phosphate buffer (pH 3.5)
|
228
nm
|
1 mL/min
|
3.89 min (SIT) and 6.12 min (REP)
|
[21]
|
|
Sitagliptin
|
Metformin
|
RP-HPLC (QbD)
|
Monolithic C10 (100 x 4.6 mm id, 5μm)
|
Methanol, Acetonitrile, and (pH 3.946) (adjusted
with Orthophosphoric acid)
|
210 nm
|
0.484
mL/min
|
4.4 min
|
[22]
|
|
Sitagliptin Phosphate
|
Metformin HCl
|
RP-HPLC (Gradient Mode)
|
Phenomenex C12 (250 mm x
4.6 mm,
5mum)
|
Acetonitrile: Phosphate buffer 0.03 M (70:30 %v/v), pH 3.5
|
218 nm
|
1 mL/min
|
5.27 min, and 1.93 min
|
[23]
|
2.
Linagliptin:
|
Compound
|
Technique
employed
|
Column
|
Mobile
Phase
|
λ
max
|
Flow
(mL/min)
|
Elution
Time
|
Ref.
|
|
Linagliptin
|
RP-HPLC
|
C18
|
70:30 v/v Phosphate buffer : Acetonitrile
|
239 nm
|
1.0 mL/min
|
2.8 min
|
[25]
|
|
Linagliptin
|
RP-HPLC
|
C18
|
75:25
v/v Methanol : 0.1M Hydrochloric acid
|
295
nm
|
1.0
mL/mi
|
3.48 min
|
[26]
|
|
Linagliptin
|
RP-HPLC (QbD, Stability Indicating)
|
Primesil C18
|
60:40 v/v 0.3% TEA : Methanol
|
292 nm
|
1.0 mL/min
|
2.823
min
|
[27]
|
3.
Tenegliptin:
|
Compound
|
Combination drug
|
Technique used
|
Column
|
Mobile Phase
|
λ max
|
Flow (mL/min)
|
Elution Time
|
Ref.
|
|
Teneligliptin
|
Remogliflozin
|
RP-HPLC
|
Discovery C18 (250 x 4.6 , 5μm)
|
Buffer Ammonium acetate : Acetonitrile (60:40)
|
229 nm
|
0.9
ml/min
|
2.176
min
|
[28]
|
|
Teneligliptin
|
Dapagliflozin
|
RP-HPLC
|
Zorbax
Eclipse Plus C18
|
10
mm ammonium acetate buffer in water, methanol, and acetonitrile
|
224
nm
|
0.6
mL/min
|
6.2
min
|
[29]
|
|
Teneligliptin
|
-
|
RP-HPLC
|
Ascentis 150 x 4.6 mm
|
Phosphate
Buffer (pH 3.0) : Acetonitrile (70:30 v/v).
|
249 nm
|
0.8
ml/min
|
6.36
min
|
[30]
|
|
Teneligliptin
|
Metformin
|
Stability
Indicating RP-HPLC
|
Kromasil C18
|
Buffer:
Acetonitrile: Methanol (65:25:10, % v/v/v)
|
254
nm
|
1.0
mL/min
|
2.842 min
|
[31]
|
4.
Trelagliptin:
|
Compound
|
Technique used
|
Column
|
Mobile Phase
|
λ max
|
Flow (mL/min)
|
Elution Time
|
Ref.
|
|
Trelagliptin
|
Chiral HPLC
|
Chiral pak AD-3 (250 x 4.6 mm, 3μm)
|
Hexane: Ethanol: Diethyl amine (70:30:0.1,% v/v)
|
275 nm
|
-
|
R-isomer: 21.7 min.
(S)-isomer: 19.3 min.
|
[33]
|
|
Trelagliptin
|
HPLC-UV
(Method III)
|
BDS
HYPERSIL C18(100 x 3 mm, 3μm)
|
Acetonitrile:
Potassium dihydrogen phosphate buffer 0.05 M (50:50, v/v), pH 3.5
|
274
nm
|
0.5
mL/min
|
1.86
min
|
[34]
|
|
Trelagliptin succinate
|
RP-HPLC
|
Cosmosil 250 x 4.6 mm, 5μm
|
Gradient
Elution: Mobile
Phase A (Buffer), Mobile Phase B (Buffer: Acetonitrile 20:80)
|
225 nm
|
1.0 mL/min
|
2.36 min
|
[35]
|
5.
Saxagliptin:
|
Compound
|
Combination drug
|
Technique used
|
Column
|
Mobile Phase
|
λ max
|
Flow (mL/min)
|
Elution Time
|
Ref.
|
|
Saxagliptin
|
Metformin
|
RP HPLC method
|
THERMO, C18, 250 x 4.6mm, 5 μm
|
0.1M
KH2PO4: Methanol (65:35)
|
256
nm
|
1.0
ml/min
|
3.436 min
|
[36]
|
|
Saxagliptin
|
Metformin and Dapagliflozin
|
Stability-indicating
RP-HPLC method
|
Kromasil
C18 column (150 x 4.6mm, 5 μm
|
0.1% OPA: Acetonitrile (60:40 % v/v)
|
230 nm
|
1.0 ml/min
|
3.423 min
|
[37]
|
|
Saxagliptin
Hydrochloride
|
Metformin Hydrochloride
|
RP-HPLC
|
Phenomenex
C18 (250 x 4.6 mm, 5 μm
|
0.02M
KH2PO4: Acetonitrile: Methanol (50:25:25, % v/v/v) at pH4.3
|
240 nm
|
1.0 ml/min
|
7.43 min
|
[38]
|
|
Saxagliptin
|
Sucralose
|
HPLC (UV Detection)
|
C8 column
|
Phosphate buffer (pH 4): Methanol (70:30 v/v)
|
230 nm
|
1 mL/min
|
3.40 min
|
[39]
|
6.
Vildagliptin:
|
Compound
|
Technique used
|
Column
|
Mobile Phase
|
λ max
|
Flow (mL/min)
|
Elution Time
|
Ref.
|
|
Vildagliptin
|
RP-HPLC (QbD approach)
|
HiQsil
C18
|
KH2PO4
Buffer :Acetonitrile :
Methanol (50:25:25 v/v/v)
|
210
nm
|
1.0
ml/min
|
3.0
min
|
[40]
|
|
Vildagliptin
|
RP-HPLC
|
Xterra
Waters C18
|
Aqueous
phase (pH 9.5 with NH4OH and H3PO4):Methanol
(60:40 v/v)
|
210
nm
|
1.0 ml/min
|
6.3 min
|
[41]
|
|
Vildagliptin
|
RP-HPLC
|
Phenomenex
C18
|
0.1 H3PO4:
Acetonitrile
(45:55 v/v)
|
210
nm
|
1.0
ml/min
|
3.25 min
|
[42]
|
7.
Alogliptin:
|
Compound
|
Combination drug
|
Technique used
|
Column
|
Mobile Phase
|
λ max
|
Flow (mL/min)
|
Elution Time
|
Ref.
|
|
Alogliptin
|
Metformin
|
RP-HPLC
|
X-Terra
C18
|
NaH2PO4:
Acetonitrile
( 70:30 v/v )
|
235
nm
|
1.0
mL/min
|
3.43
min
|
[44]
|
|
Alogliptin
|
Pioglitazone
and Metformin
|
Stability-Indicating
RP-HPLC
|
ACE
C18
|
Acetonitrile:
Potassium dihydrogen phosphate buffer (30:70 v/v)
|
254
nm
|
1.0
mL/min
|
4.68 min
|
[45]
|
|
Alogliptin
|
Pioglitazone
|
RP-HPLC
|
Zorbax
C8
|
0.1M
Ammonium Acetate: Methanol
( 50:50, v/v )
|
248
nm
|
1.0
mL/min
|
2.883
min
|
[46]
|
CONCLUSION
The method development and validation of
accurate analytical framework are important for ensuring of gliptin in
pharmaceutical application. When using of UV-visible spectrometry provide an
efficient and cost effective it get rapid analysis, or RP-HPLC shows superior
sensitivity and accuracy for purity and stability testing.
By adhering o ICH and GMP standard, the
validated method gurantee regulatory complianceand therapeutic reliability. It
get robust quality control of gliptin like sitagliptin, Trelagliptin is safe
and effective clinical management of type 2 diabetes.
CONFLICT
OF INTEREST
The
authors declare that there are no conflicts of interest regarding the
publication of this manuscript. This review research was conducted without any
commercial or financial relationships that could be construed as a potential
conflict of interest.
ACKNOWLEDGEMENT
The
authors thankful to the management of JIIU’s Ali
Allana College of Pharmacy, Akkalkuwa, for providing the necessary academic
resources and facilities to complete this review.
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