Author(s):
Premjit S Nannaware, Suhas S. Siddheshwar, M.H. Kolhe
Email(s):
premjitnannaware1997@gmail.com
DOI:
10.52711/2349-2988.2021.00019 
Address:
Premjit S Nannaware, Suhas S. Siddheshwar, M.H. Kolhe
Department of Quality Assurance Techniques, Pravara Rural Collage of Pharmacy, Pravaranagar, Loni, Tal- Rahata, Dist-Ahmednagar, Maharashtra, India, Pin Code 413736.
*Corresponding Author
Published In:
Volume - 13,
Issue - 2,
Year - 2021
ABSTRACT:
Linagliptin is an oral anti- diabetic drug that reduces blood sugar (glucose) levels in patients with type 2 diabetes. Linagliptin is a member of a class of drugs that inhibit the enzyme, dipeptidyl peptidase-4 (DPP-4 inhibitors). It is widely used in the treatment of type –II diabetes mellitus which is characterized by insulin resistance in peripheral tissue and insulin secretory defect of the ß – cells. Linagliptin is been approved by the US food and Drug administration 2 may 2011 for the management of type –II diabetes. There are a wide range of analytical techniques were available for the analysis of linagliptin in pharmaceutical and biological samples. HPLC with UV detection is applicable in the case of analysis of linagliptin in pharmaceuticals which provide us cost effective accurate method when compare with more advance techniques. This review depicts the reported Spectrophotometric and Chromatographic methods; developed and validated for estimation of Linagliptin alone or on combination with Metformin or Empagliflozin. This review focus on different analytical methods for the estimation of Linagliptin in pharmaceutical formulations. From this elaborate literature review it was found that, till date there is no RP-HPLC method available for the determination of Linagliptin with Metformin or Empagliflozine using Design of Expert or Quality by Design.
Cite this article:
Premjit S Nannaware, Suhas S. Siddheshwar, M.H. Kolhe. A Review on Analytical Methods for Estimation of Linagliptin in Bulk and Tablet Dosage form. Research Journal of Science and Technology. 2021; 13(2):127-2. doi: 10.52711/2349-2988.2021.00019
Cite(Electronic):
Premjit S Nannaware, Suhas S. Siddheshwar, M.H. Kolhe. A Review on Analytical Methods for Estimation of Linagliptin in Bulk and Tablet Dosage form. Research Journal of Science and Technology. 2021; 13(2):127-2. doi: 10.52711/2349-2988.2021.00019 Available on: https://rjstonline.com/AbstractView.aspx?PID=2021-13-2-10
REFERENCE:
1. FDA Approves Type 2 Diabetes Drug from Boehringer Ingelheim and Lilly". 3 May 2011.
2. Four Phase III Trials Confirm Benefits of BI’s Oral, Once-Daily Type 2 Diabetes Therapy". Genetic Engineering and Biotechnology News. 28 June 2010.
3. H. Spreitzer (September 1, 2008). "Neue Wirkstoffe - BI-1356" (in German). Österreichische Apothekerzeitung (18/2008): 918
4. Wang Y, Serradell N, Rosa, E Castaner, R BI-1356.Drugs of the Future 2008; 33(6): 473– 477.
5. Lakshmi B, Reddy TV. A novel RP – HPLC Method for the Quantification of Linagliptin in formulations. J Atoms and Molecules 2012; 2(2): 155–164.
6. Archana, M, Sriram, N and Gayasuddin, Md. Method development and validation of RP-HPLC method for determination of antidiabetic agent linagliptin in bulk and pharmaceutical formulation. Int. J. Med. Chem and Analysis, 2013, 3(1): 1-5.
7. Boehringer Ingelheim and Lilly Report: FDA approves type 2 diabetes drug, (2011).
8. U.S. Food and Drug Administration. October 17, 2006. Retrieved 2006-10-17
9. Behme, Margaret T; Dupré, John; McDonald, Thomas J (2003). "Glucagon-like peptide 1 improved glycemic control in type 1 diabetes". BMC Endocrine Disorders. 3 (1): 3. Doi:10.1186/1472-6823-3-3. PMC 154101. PMID 12697069.
10. Zheng, Sean L.; Roddick, Alistair J.; Aghar-Jaffar, Rochan; Shun-Shin, Matthew J.; Francis, Darrel; Oliver, Nick; Meeran, Karim (17 April 2018). "Association between Use of Sodium-Glucose Cotransporter 2 Inhibitors, Glucagon-like Peptide 1 Agonists, and Dipeptidyl Peptidase 4 Inhibitors with All-Cause Mortality in Patients with Type 2 Diabetes". JAMA. 319 (15):15801591. Doi:10.1001/jama.2018.3024. PMC 5933330. PMID 29677303.
11. Thomas L, Eckhardt M, Langkopf e, et al. ®-8-(3-amino-piperidin-1-yl)-7but-2-ynyl-3-methyl-1-(4-methyl-quinazolin-2-ylmethyl)-3,7-dihydro-purine2,6-dione (BI 1356), a novel xanthine-based dipeptidyl peptidase 4 inhibitor, has a superior potency and longer duration of action compared with other dipeptidyl peptidase-4 inhibitors. J Pharmacol Exp Ther. 2008; 325:175–182.
12. Forst T, Uhlig-Laske B, Ring A, et al. The oral DPP-4 inhibitor linagliptin significantly lowers HbA1c after 4 weeks of treatment in patients with type 2 diabetes mellitus. Diabetes Obes Metab. 2011;13: 542–550
13. Tradjenta TM [package insert]. Ridgefield, CT: Boehringer Ingelheim International; July, 2011.
14. David Watson G, Pharmaceutical Analysis (3rd Ed., Churchill Livingstone, London: Harcourt Publishers Limited, Essex CM 20 2JE, 2012).
15. Oliver G, Gerrit R, and Maxmilian VZ, Leading Pharmaceutical Innovation, „Trends and drivers for Growth in the pharmaceutical industry, (2nd Ed., Springer, 2008)12-15.
16. Br. Jay, J. Kelvin, and B. Pierre, Understanding and Implementing Efficient Analytical Methods Development and Validation, 2003.
17. R.M. Christopher, and W.R. Thomas, Quality Systems approach to Pharmaceutical cGMP Development and validation of Analytical Methods, (1st Ed., 2005) 147-152.
18. Sharma BK, Instrumental method of chemical analysis (29th Ed., Meerut, Chromatography, HPLC, Goel Publishing House, 2013) 286- 385.
19. Sujan B, Masud Kaisar Md, Salim Hossain Md. Development and Validation of a Simple and Rapid UV Spectrophotometer Method for Assay of Linagliptin in Bulk and Marketed Dosage Form. Indian Journal of Novel Drug Delivery 2013; 5:221-224.
20. Sujan B, Palash K, Md. Anowar Hossain M. Development and Validation of a UV Spectrophotometric Method for Determination of Vildagliptin and Linagliptin in Bulk and Pharmaceutical Dosage Forms. Bangladesh Pharmaceutical Journal 2015; 18:163-168.
21. Sarif Niroush K, Jane T J, Vipin P. Stability Indicating UV Spectrophotometric Method for Linagliptin and Metformin in Pharmaceutical Dosage Form. Pharm Methods 2017; 8: 121-126.
22. Chandra K S, Sudhakar P, Mohan Rao T, Vijaya Babu P, Manikanta K A. A New Uv-Method for Determination of Linagliptin in Bulk and Pharmaceutical Dosage Form. International Journal of Universal Pharmacy and Bio Sciences 2013; 2:1-6.
23. Padmaja N, Veerabhadram G. Development and validation of analytical method for Simultaneous estimation of Empagliflozin and Linagliptin in bulk drugs and combined dosage forms using UV-visible spectroscopy. Der Pharmacia Lettre 2015; 7:306-312.
24. Amrutiya Foram R, Patel Bhumi R, Patel Jaimin G, Vegad Kunjal L, Patel Amit S, Dr. Darji Vinay C. Development and Validation of First Order Derivative Uv-spectrophotometric Method for Determination of Empagliflozin and Linagliptin. International Journal of Pharmaceutics and Drug Analysis 2017; 5:129-135.
25. Lakshman R B. A Validated RP-HPLC Method for the Determination of Linagliptin. Am J. Pharm Tech Res. 2012; 2:462-470.
26. Smita S. A, Saroj G, Ravindra B. Spectrophotometric and Chromatographic Estimation of Linagliptin in Bulk and Tablet Dosage Form. International Journal of Chem Tech Research 2017; 10:736-744.
27. Sneha R B, Anvesha V G, Krishna R. G. Quality by Design Based Hplc Assay Method Development and Validation of Linagliptin in Tablet Dosage Form. Ejpmr 2017; 4:486-494.
28. Sara S M, Eman I E, Dalia A H, Magda A B. Stability Indicating HPLC-DAD Method for the Determination of Linagliptin in Tablet Dosage Form: Application to Degradation Kinetics. Journal of Chromatographic Science 2016: 54:1560–1566.
29. Archana V, Sriram N, Gayasuddin Md. Method Development and Validation of Rp-Hplc Method for Determination of New Antidiabetic Agent Linagliptin in Bulk and in Pharmaceutical Formulation. IJMCA 2013; 3:1-5.
30. Vijaya Sri K, Anusha M, Ravinder Reddy S. A Rapid RP-HPLC Method development and Validation for the Analysis of Linagliptinin Bulk and Pharmaceutical Dosage Form. Asian J. Pharm. Ana. 2015; 5:16-20.
31. Zubair Md, Murali B V, Rajesh G G. RP-HPLC method development and validation of Linagliptin in bulk drug and pharmaceutical dosage form. Der Pharmacia Sinica 2014; 5:123-130.
32. Md. Al Bratty, Hassan A. Alhazmi, Sadique Akhtar Javed, Keddal, G, and Sami El Deeb,. Development and validation of LC – MS/MS method for simultaneous determination of metformin and four gliptins in human plasma. Chromatographia, 2017:1-9.
33. Kavitha, KY., Geetha, G., Hariprasad, R., Kaviarasu, M, and Venkatanarayana, R,. Development and validation stability indicating RP-HPLC method for simultaneous estimation of linagliptin and metformin in pure and pharmaceutical dosage form. J. Chemical and Pharmaceutical Research, 2013, 5(1) :230-235.
34. Sheena Moncy., Rohini Reddy, G., Sunil Kumar, Chaitanya, P., Priyanka, G., and Hima Bindu, E. Simultaneous determination of metformin hydrochloride and linagliptin by RP-HPLC in bulk and Pharmaceutical formulation. Indo American Journal of Pharmaceutical research, 2014: 4047-4053.
35. Ravi varma, A, Shanmukha Kumar, J.V, and Mutta Reddy, S. Stability indicating liquid chromatographic method for simultaneous assay of anti-diabetic drugs linagliptin and metformin in pure and commercial tablet dosage form. Int. Journal of Innovative Technology and research, 2014, 2(4): 1131-1138.
36. Magesh, A., Nagrajuna, H S., Aldhu Baib, Anurup Nair, and Venu Gopal, K N, Simultaneous determination of metformin and three gliptins in pharmaceutical formulation using RP-HPLC: Application to stability studies on linagliptin tablet formulation. Pharmaceutical research, 2014, 48(4):45-53.
37. Naazneen, S and Sridevi, A, Development and validation of stability indicating RP-HPLC method for simultaneous estimation of empagliflozin and linagliptin in tablet formulation. Der Pharmacia Lette, 2016, 8(17): 57-65.
38. Swetha Pasha, Ravindra Kumar, Y, and Ravi Chander, M, LC-MS/MS and NMR characterization of key impurities in linagliptin and pramipexole. Journal of liquid chromatography and related technologies, 2015:1-46.
39. Nidhi D, Singh G N, Anchal T, Rakesh B, Raghav C S. Development and Validation of ultra-performance liquid chromatography (UP-LC) method for estimation of a new anti-diabetic drug Linagliptin in bulk and its tablet formulation. Indian Journal of Chemistry 2014; 53:1136-1139.