Author(s): Archana B. Gore, Manojkumar K. Munde, Nikita B. Rukhe, Nilesh S. Kulkarni

Email(s): manojpcist@gmail.com , nileshpcist@gmail.com

DOI: 10.52711/0975-4377.2022.00013   

Address: Archana B. Gore, Manojkumar K. Munde*, Nikita B. Rukhe, Nilesh S. Kulkarni
PES Modern College of Pharmacy (for Ladies), Affiliated to Savitribai Phule Pune University, Moshi, Pune-412105, Maharashtra, India.
*Corresponding Author

Published In:   Volume - 14,      Issue - 1,     Year - 2022


ABSTRACT:
Gliptin is the class of antidiabetic medicine also called as dipeptidylpeptidase-4. DPP-4 (dipeptidyl peptidase-4) inhibitors (or "gliptins") represent a class of oral anti-hyperglycaemic agents that inhibit the enzyme DPP-4, thus augmenting the biological activity of the "incretin" hormones (glucagon-like peptide-1 [GLP-1] and glucose-dependent insulinotropic polypeptide [GIP]) Sitagliptin, Saxagliptin, Alogliptin, Linagliptin, Vildagliptin are the Gliptin class inhibitor for the treatment of type 2 diabetes mellitus and they decrease the breakdown of the incretin hormones such as glucagon like peptide 1 (GLP-1). All together gliptins have a good oral bioavailability which is not significantly influenced by food intake. PK/pharmacodynamics characteristics, that is, sufficiently prolonged half-life and sustained DPP-4 enzyme inactivation, generally allow one single oral administration per day for the management of T2DM; the only exception is vildagliptin for which a twice-daily administration is recommended because of a shorter half-life DPP-4. This paper is an updated review, providing an analysis of both the similarities and differences between the various compounds known as gliptins, currently used in the clinic (sitagliptin, saxagliptin, alogliptin linagliptin and vildagliptin). This paper discusses the pharmacokinetic and pharmacodynamic characteristics of gliptins. In this review we complied analytical method development and determination of the Gliptin inhibitors. Table no.1, 2, 3, 4, 5, shows the analytical method development and validation of Sitagliptin, Saxagliptin, Alogliptin, Linagliptin, and Vildagliptin alone and with its combination by the HPCL method.


Cite this article:
Archana B. Gore, Manojkumar K. Munde, Nikita B. Rukhe, Nilesh S. Kulkarni. A Review on HPLC Method Development and Validation for Gliptin Class: New Oral Antidiabetic Agents. Research Journal of Pharmaceutical Dosage Forms and Technology.2022; 14(1):79-6. doi: 10.52711/0975-4377.2022.00013

Cite(Electronic):
Archana B. Gore, Manojkumar K. Munde, Nikita B. Rukhe, Nilesh S. Kulkarni. A Review on HPLC Method Development and Validation for Gliptin Class: New Oral Antidiabetic Agents. Research Journal of Pharmaceutical Dosage Forms and Technology.2022; 14(1):79-6. doi: 10.52711/0975-4377.2022.00013   Available on: https://rjpdft.com/AbstractView.aspx?PID=2022-14-1-13


REFERENCES:
1    André J Scheen. A review of gliptins in 2011. 2012 Jan; 13(1):81-99. doi: 10.1517/14656566.2012.642866.Available on pubmed.ncbi.nlm.nih.gov
2    Michael A Nauck , Meier. The incretin effect in healthy individuals and those with type 2 diabetes: physiology, pathophysiology, and response to therapeutic interventions.2016 Jun; 4(6): 525-36.doi: 10.1016/S2213-8587(15)00482-9. Available on.www.diabetes.co.uk/diabetes-medication/dpp-4.
3    www.goodrx.com/gliptins
4    Emilie S Andersen, Carolyn F Deacon, Jens J Holst. Mechanism of action of the DPP-4 inhibitors.2018 Jan; 20(1):34-41. Doi: 10.1111/dom.13018.www.diabetes.org.uk › tablets-and-medication › dpp-4-in
5    Erin E Mulvihill  1 , Daniel J Drucker.Pharmacology, physiology, and mechanisms of action of dipeptidyl peptidase-4 inhibitors:2014 Dec; 35(6): 919-1019doi:10. 1210/er2014-1035 Aailable on www.sciencedirect.com/topics/pharmacology
6    www.medicineindia.org/pharmacology-for-generic/2797/sitagliptin
7    Ganesh V Sangle, Mohan Patil.Evaluation of pharmacokinetic and pharmacodynamic parameters following single dose of sitagliptin:2018 May; 74(5):561-569.doi: 10.1007/s00228-018-2433-5.available on www.rxlist.com/januvia-drug clinical-pharmacology/.htm
8    www.healthline.com/health/sitagliptin/oral-tablet
9    En wikipidia.org
10    en.m.wikipedia.org/wiki
11    www.ema.europa.eu/en/documents/scientific
12    Nancy A Thornberry; Baptist Gallwitz. Mechanism of action of inhibitors of dipeptidyl-peptidase-4 (DPP-4):2008 Jul;11(4):512-32doi: 10.1016/j.beem.2009.03.004available onpubchem.ncbi.nlm.nih.gov/compound/Sitagliptin
13    Rasha M. Ahmed, Ghada M. Hadad, Ahmed E. El-Gendy & Ahmed Ibrahim: Development of HPLC Method for Determination of Sitagliptin in Human Plasma using Fluorescence Detector by Experimental Design Approach.2018; vol.8 (6): 813 – 828.doi: 10.1080/22297928.2018.1545603
14    Balamurugan Krishnan, Kirtimaya Mishra: Quality by Design based Development and Validation of RP-HPLC Method for Simultaneous Estimation of Sitagliptin and Metformin in Bulk and Pharmaceutical Dosage Forms. 2020; vol.10 (4):512-518. doi: 10.5330/ijpi.2020.4.89
15    I. Arulraj, P. Vembu and A. Chenthilnathan: Development and Validation of RP-HPLC Method for the Estimation of Sitagliptin Phosphate in Bulk and Its Tablet Dosage Form. 2016; vol.4 (3):139-143.
16    Sammi Akter, Arghya Prosun Sarkar, Md. Taleb Hossain, Md. Sadikuzzaman, Bidduth Kumar Sarkar, Pijus Saha& Sukalyan Kumar Kundu1 Development and Validation of HPLC Method for Estimation of Sitagliptin in Tablet Dosage Form. 2020
17    Swati D. Bhende, Murali Balaram Varanasi, Konde Abbulu, M. Divya Swetha, V. Shravanthi, J. Karuna Kumari and T. Shayamala RP-HPLC Method for the Simultaneous Estimation of Sitagliptin Phosphate and Metformin Hydrochloride in Combined Tablet Dosage Forms.2012Vol. 28(1):463-469
18    KavithaD, S. K. Sahoo, Venkateswara Rao P., Nagamani M., Bhagyalaxmi:Development and validation of RP HPLC method for determination of metformin and sitagliptin in bulk and pharmaceutical dosage form feb.2017;vol. 5(2):34-39
19    pubchem.ncbi.nlm.nih.gov/compound/Alogliptin
20    aksci.com/item_detail.php?cat=X4993
21    en.wikipedia.org/wiki/Alogliptin
22    pubchem.ncbi.nlm.nih.gov › compound › Alogliptin
23    Hani Naseef, Ramzi Moqadi, and Moammal Qurt: Development and Validation of an HPLC Method for Determination of Antidiabetic Drug Alogliptin Benzoate in Bulk and Tablets. 2018; Vol(18); 1-7.doi:https://doi.org/10.1155/2018/1902510
24    Godge R. K., Shinde G. S, Bhosale M. S:RP-HPLC Method for estimation of Alogliptin and Glibenclamide in Synthetic mixture.2020; vol.13(2):
25    Yadav Priyanka J, Jadhav Sayali S, Mohite S. K.Rajarambapu: development and validation of rp-hplc method for alogliptin benzoate in bulk drug and dosage form.2014; Vol. 1(2): 1-9
26    Vinyas M, Swapna Velivela, Gopi Yadav, Nikunja B Pati, VRM Gupta: Analytical Method Development and Validation of Alogliptin by RP-HPLC Method. 2016; 9(7):775-778. doi:10.5958/0974-360X.2016.00148.7
27    Yogesh Bafana, Yogendra Singh, Gazala Parveen, Mrunal Shirsat, Sampat Naval: Development and Validation of Stability-Indicating RP-HPLC Method for Estimation of Alogliptin and Linagliptin.2018; Vol.9(11): 20196-20216. doi: https://doi.org/10.15520/ijcrr.v9i11.862
28    en.m.wikipedia.org/wiki/Saxagliptin
29    Sohita Dhillon.Saxagliptin A Review in Type 2 Diabetes:2015; Oct 75(15):1783-93. Doi:10.1007/s40265-015-0473-z. Available onpubchem.ncbi.nlm.nih.gov/compound/Onglyza
30    Gaikwad D. D., Patel S. G, Waman S. A, Jadhav S. L, Dhobale S.M: Method Development and Validation of Saxagliptin Hydrochloride by RP-HPLC Method. 2020; Vol.9 (9): 22-28.
31    Bharat G. Murarka, Debarshi Kar Mahapatra, Sandhya M. Bagde, Ujwala N. Mahajan, Ajay G. Pise : Saxagliptin and Metformin Estimation in Tablet Formulation 2020; 10(2):27-36
32    P. B. N. Prasad, K. Satyanaryana, G. Krishnamoha: Development and Validation of a Method for Simultaneous Determination of Metformin and Saxagliptin in a Formulation by RP-HPLC.2015; 6, 841-850. doi: 10.4236/ajac.2015.611080
33    Dr. Pradnya Lokhande:Development and Validation of an HPLC Method for the Analysis of Saxagliptin in Bulk Powder.2020; Vol.4 (2) 2020:37-41.
34    www.selleckchem.com/products/linagliptin-bi-1356.html
35    www.accessdata.fda.gov/drugsatfda_docs/nda/2011/...
36    www.sciencedirect.com/science/article/pii/S
37    en.wikipedia.org/wiki/Linagliptin
38    R. Maruthi, R.S. Chandan, Anand Kumar Tengli: Development and Validation of Stability Indicating RP-HPLC Method for The Estimation of Linagliptin in Active Pharmaceutical Ingredients. 2018; Vol. 7 (1):12-32.
39    Prathyusha Vemula, Dilip Dodda, Uma Mahesh Balekari, Shyam panga, Ciddi Veeresham: Simultaneous determination of linagliptin and metformin by reverse phase-high performance liquid chromatography method: An application in quantitative analysis of pharmaceutical dosage forms. 2015; Vol. 6 | (1):25-28. DOI:10.4103/2231-4040.150368
40    V. sruthi, B. Poornimaa: analytical method development and validation for simultaneous estimation of linagliptin and empagliflozin in bulk and pharmaceutical formulation by RP-HPLC. 2019; vol.16 (2):555-568.
41    A.C.K.Prasanna, papain’s, priyanka:method development and validation of linagliptin and metformin by using RP-HPLC in pharmaceutical dosage form.2015;vol.6(1):2673-2678
42    Mahesh Attimarad, Sree Harsha Nagaraja, Bandar E Aldhubaib, Anroop Nair and Venugopala K N: Simultaneous Determination of Metformin and Three Gliptins in Pharmaceutical Formulations Using RP HPLC: Application to Stability Studies on Linagliptin Tablet Formulation.2014; Vol. (4):45-53. DOI: 10.5530/ijper.48.4.7
43    S. Srinivasa Rao, M. Chandra Shekar, and N. Nagaprasanna and T. Supriya: analytical method development and validation of antidiabetic drugs (metformin and linagliptin) in tablet dosage form by using rp-hplc method. 2019; Vol.5(8):113-120
44    Henness S, Keam SJ. Vildagliptin. 2006; 66(15):1989-2001; discussion 2002-4. doi: 10.2165/00003495-200666150-00007. Available onpubchem.ncbi.nlm.nih.gov/compound/Vildagliptin.2006(66)15
45    www.guildlink.com.au/gc/ws/nv/pi.cfm?product=nvpgamor10216
46    www.jocpr.com/articles/formulation-design
47    A. M. Kashida, D. A. Ghorpadea, P. P. Toranmala, and S. C. Dhawale: Development and Validation of Reversed Phase HPLC Method for the Determination of Vildagliptin Using an Experimental Design1.2015; Vol. 70(4): 510–515.doi: 10.1134/S1061934815040061
48    W. Abu Dayyih, M. Hamad, E. Mallah, A. Abu Dayyih, R. Awad, Z. Zakaria and T. Arafat: method development and validation of vildagliptin and metformin hcl in pharmaceutical dosage form by reverse phase–high performance liquid chromatography (RP-HPLC) .2018; Vol 10 (1), 36-45. DOI:10.13040/IJPSR.0975-8232.9(7).2965-72
49    Shrikrishna B. Baokar, Sugandha V. Mulgund Nisharani S. Ranpise: Development and Validation of RP-HPLC Method for Simultaneous Estimation of Vildagliptin and Metformin.2013; 5(2): 95-98.
50    D Raju, P Karunakar, China Babu Jonnakuti and N Asha: Simultaneous estimation of vildagliptin and metformin hydrochloride by using RP-HPLC in bulk and pharmaceutical dosage form. 2019; 8(6): 296-301.

Recomonded Articles:

Author(s): Gopal Rao M., M. A. Amutha Gnana Arasi, S. Jayaprakash, M. Arun Kumar, P. Kavitha

DOI:         Access: Open Access Read More

Author(s): Dipti G. Phadtare, Amol R. Pawar, R.B. Saudagar, Govind K.Patil

DOI: 10.5958/0975-4377.2017.00002.7         Access: Open Access Read More

Author(s): Swapnil T. Deshpande, P. S. Vishwe, Rohit D. Shah, Swati S. Korabu, Bhakti R. Chorghe, DG Baheti

DOI:         Access: Open Access Read More

Author(s): Yamunappa, Ravi Kumar, Pooja Shetty, Prathibha Suvarna, Narayana Swamy VB

DOI: 10.5958/0975-4377.2016.00012.4         Access: Open Access Read More

Author(s): Chirag A. Patel, Priyal R. Patel, Dhrubo Jyoti Sen,Jayvadan K. Patel

DOI:         Access: Open Access Read More

Author(s): Hardik B. Rana, Kajol Patel, Mansi Dholakia, Vaishali T. Thakkar, Mukesh C. Gohel, Tejal R. Gandhi

DOI: 10.5958/0975-4377.2017.00006.4         Access: Open Access Read More

Author(s): Patil Namrata D., Gondkar S.B., Saudagar R.B.

DOI: 10.5958/0975-4377.2016.00033.1         Access: Open Access Read More

Author(s): Swati Talokar, Rohan R Vakhariya, A.R Dhole

DOI: 10.5958/0975-4377.2017.00005.2         Access: Open Access Read More

Author(s): Kritika Kanoujia, Chandraprabha Dewangan, Ayushi Masih, Dipti Sinha, Divya Oraon, Manisha Jaiswal, Monika Sahu, Ranjeeta Kumari, Sapna Pradhan, Ravi Suman, Rajkishan Dewangan, Roman Banjare, Pradeep Paikra, Mukesh Rawtiya, Mukta Agrawal, Ajazuddin, D. K. Tripathi, Amit Alexander

DOI: 10.5958/0975-4377.2018.00015.0         Access: Open Access Read More

Author(s): Masheer Ahmed Khan

DOI:         Access: Open Access Read More

Author(s): Sushant R. Jagtap, D.G Phadtare, R.B. Saudagar

DOI: 10.5958/0975-4377.2016.00021.5         Access: Open Access Read More

Author(s): B. Thangabalan, Ch. Sandhya, N. Sunitha, S. Manohar Babu

DOI:         Access: Open Access Read More

Author(s): Swati Rawat, Shradha Sangali, Akhilesh Gupta

DOI: 10.5958/0975-4377.2018.00001.0         Access: Open Access Read More

Author(s): P. Lekshmi, K. Pramod, K.C. Ajithkumar

DOI: 10.5958/0975-4377.2016.00007.0         Access: Open Access Read More

Author(s): V. Saikishore, G. Srikanth, Ch. Pooja, Y. Mrudula, R. Pavani, Ch. Jyosthna , C. Mayuren

DOI:         Access: Open Access Read More

Author(s): Shoaib Ahmad

DOI: 10.5958/0975-4377.2016.00041.0         Access: Open Access Read More

Research Journal of Pharmaceutical Dosage Forms and Technology (RJPDFT) is an international, peer-reviewed journal, devoted to pharmaceutical sciences. ...... Read more >>>

RNI: Not Available                     
DOI: 10.5958/0975-4377 


Recent Articles




Tags