1. 1
PRESENTATION ON
“New RP-HPLC method development and
validation for the simultaneous estimation of
evogliptin and metformin hydrochloride in bulk
and pharmaceutical dosage form’’
In Partial Fulfillment for the requirements for the award
of
Master of Pharmacy in
Pharmaceutical Analysis
Department of Pharmaceutical Analysis
Karnataka college of Pharmacy, Bangalore – 560064
Feb - 2024
Presented By,
Venkatesan R
M.Pharm II - Year
Guided By,
Mr. T. Srinivas Rao
Associate Professor
2. KARNATAKA COLLEGE OF PHARMACY
BANGALORE
Content
Need for the study
Drug Profile
Mechanism of Action
Literature Review
Objective of the study
Method of data collection
References
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3. KARNATAKA COLLEGE OF PHARMACY
BANGALORE
1. Need for the study:
• Diabetes, also known as diabetes mellitus, is a group of common endocrine diseases characterized
by sustained high blood sugar levels.
• Diabetes is due to either the pancreas not producing enough insulin, or the cells of the body not
responding properly to the insulin produced. As of 2019, an estimated 463 million people had
diabetes worldwide accounting for 8.8% of the adult population. Type 2 diabetes makes up about
90% of all diabetes cases.
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4. KARNATAKA COLLEGE OF PHARMACY
BANGALORE
• A drug substance that helps a person with diabetes control their level
of glucose (sugar) in the blood. Metformin is generally recommended as a first-line treatment for
type 2 diabetes, as there is good evidence that it decreases mortality.
• It works by decreasing the liver's production of glucose, and increasing the amount of glucose
stored in peripheral tissue.
• Antidiabetic agents include insulin and the oral hypoglycemic agents. Evogliptin and metformin
hydrochloride are the drugs used to treat diabetes and it is manufactured by a Alkem laboratories
Pvt ltd in Mumbai. Evogliptin and metformin hydrochloride combination was approved in
22.10.2018.
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5. KARNATAKA COLLEGE OF PHARMACY
BANGALORE
2. Drug Profile
a) Evogliptin Tartrate b) Metformin Hydrochloride:
Structure: Structure:
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6. KARNATAKA COLLEGE OF PHARMACY
BANGALORE 6
S.No Parameters Evogliptin Tartrate Metformin Hydrochloride
1. IUPAC Name (3R)-4-[(3R)-3-amino-4-(2,4,5-
trifluorophenyl)butanoyl]-3-[(2-
methylpropan-2-yl)oxymethyl]piperazin-2-
one;(2R,3R)-2,3-dihydroxybutanedioic acid
N, N-
Dimethylimidodicarbonimidic
diamide Hydrochloride.
2. Molecular
formula
C23H32F3N3O9 C4H12ClN5
3. Molar Mass 551.5 g/mol 165.62 g/mol-1
4. Boiling Point 571.5±50.0 °C at 760 mmHg. 172.5±23.0 °C at 760 mmHg.
5. Storage Condition 4°C, sealed storage, away from moisture. Store at or below 25°C. Protect
from heat, light and moisture
6. Pka 13.69 (Strongest Acidic), 8.78 (Strongest
Basic).
12.4.
7. Drug Category It is antidiabetic drug. It is an oral anti-diabetic drug.
8. Solubility Water, ethanol, chloroform and ethyl acetate. water, slightly soluble in alcohol.
7. KARNATAKA COLLEGE OF PHARMACY
BANGALORE
3. Mechanism of action:
a) Evogliptin tartrate:
Reduce degradation of endogenous
glucagon-like peptide 1 (glp-1) to
increase insulin secretion and satiety
and decrease glucagon.
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b) Metformin Hydrochloride:
Metformin decreases hepatic glucose
production, decreases intestinal
absorption of glucose, and improves
insulin sensitivity by increasing
peripheral glucose uptake and utilization
8. KARNATAKA COLLEGE OF PHARMACY
BANGALORE
3. Literature Review:
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Author
Name
Method Column Flow rate Wavelength Solvent used RT
Surya
Prakash
Gupta et al.
RP-HPLC C-18
(4.6×150mm, 5µ
Kromasil
column)
0.8 ml/min -
phosphate buffer
and acetonitrile
(30:70 v/v)
(EGT) 7.03
min and
(MFN) 9.50
min .
Poojitha Sai
Kuruva et
al.
RP-HPLC Waters XTerra
RP-18 (150X4.6
mm), 3.5μ
column
1.0 ml/min
228 nm
Acetonitrile:
KH2PO4:
Methanol in the
ratio of
(50:40:10% v/v)
(EGT) 4.468
min and
(MFN) 2.730
min .
Manisha C.
Kotakiya et
al.
RP-HPLC phenomenex
Luna C18
column
1.2 ml/min
(EGT) 230
nm &
(MFN) 210
water: Acetonitrile
(25:75v/v)
(EGT) 2.956
min and
(MFN) 2.009
min .
9. KARNATAKA COLLEGE OF PHARMACY
BANGALORE 9
Author
Name
Method Column Flow rate Wavelength Solvent used RT
Rupali Bagde
et al.
RP-HPLC C-18
(4.6×150mm,
5μ Hypersil
column)
0.8 ml/min
254 nm. methanol:
water
(70:30v/v)
(EGT) 2.107
min and
(MFN) 2.548
min.
Author
Name
Method Concentration used Wavelength Regression coefficient
Neetu
Agrawal et al.
UV
spectroscopy
10–100 µg/ml 233.1 nm
(EGT) and
267.0 nm
(MFN)
R2 = 0.9986 for Evogliptin and
R2 = 0.9983 for Metformin
10. KARNATAKA COLLEGE OF PHARMACY
BANGALORE
4. Objective of the study
This research work attempts to establish sensitive and accurate method for the development and
validation of analytical methods for the estimation of Evogliptin and Metformin Hydrochloride in
the bulk and pharmaceutical dosage form.
To develop a new sensitive and accurate RP-HPLC method.
To Validate the proposed newly developed method in accordance with the analytical parameters
mentioned in the ICH guidelines.
To apply the proposed newly developed method for the analysis of Evogliptin and Metformin in
the bulk and pharmaceutical dosage form.
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11. KARNATAKA COLLEGE OF PHARMACY
BANGALORE
5. Method of data collection
UV-Spectrophotometer (Shimadzu 1700 & 1800) and HPLC (Agilent 1120 binary, gradient, Dionex
3000) etc is available for use during the course of the work.
Development and validation of a new analytical method for the determination of Evogliptin and
Metformin Hydrochloride shall be carried out at the Department of Pharmaceutical Analysis,
Karnataka College of Pharmacy, Bangalore-64, India.
Various data collected for the analytical method development either by spectrophotometry or by RP-
HPLC will be treated statistically to find its compliance with ICH or Pharmacopeial guidelines.
Typical analytical parameters such as Linearity, Range, Precision, Specificity, Accuracy, Ruggedness
and Robustness will be determined.
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BANGALORE
7. References:
1. Gupta, S. P., Gupta M. RP-HPLC Based Stability Indicating Assay of Evogliptin and Metformin: Development and Validation of
the Analytical Method. International Journal of Pharmaceutical Sciences and Nanotechnology, 2023;16(2):6438–6444.
2. Kaveripakam, S. S., Kuruva, P. S., & Adikay, S. Development and validation of an RP-HPLC method for determination of
Metformin and Evogliptin in bulk and pharmaceutical dosage forms. Biomedicine (Trivandrum), 2023;43(1),189–195.
3. Patel, A. A., Kotadiya, M. C., & Shah, B. Development and analytical method validation for simultaneous estimation of evoglptin
tartrate and metformin hydrochloride in combine dosage form. International Journal of Pharmaceutical Quality Assurance,
2022;13(04),504–509.
4. Rupali Bagde, S Karole, Anup K Chakraborty and Kavita R Loksh. Development and validation of RP-HPLC method for
simultaneous estimation of metformin and evogliptin in dosage form. International Journal of Current Research, 2022;14(11),
22878-22881.
5.Agrawal, N., & Pathak, S. Eco-friendly UV spectrophotometric method for simultaneous estimation of evogliptin and metformin
hydrochloride in bulk and combined tablet dosage form. Brazilian Journal of Analytical Chemistry, 2022;9(37),140-150.
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