Abstract
The frequency of Type 2 Diabetes Mellitus worldwide is rising rapidly and is estimated to reach 4.4% of the world’s population or about 366 million people by 2030. In the view of National Diabetes Statistics report 2017, 30.3 million people have diabetes in the United States (9.4%) of total population, out of which, 23.1 million are diagnosed and 7.2 million (23.8%) people with Diabetes are undiagnosed. One of the recently introduced therapeutic classes is Sodium Glucose co- Transporter 2 (SGLT2) Inhibitors. Since 2010 USFDA has approved 6 single dose and 7 fixed dose combinations for treatment of Type 2 Diabetes Mellitus. SGLT2 Inhibitors such as Canagliflozin, Dapagliflozin and Empagliflozin are in combinations with most of the dosage forms. This article reviews published analytical methods reported so far in the literature to find SGLT2 inhibitors. They include various techniques like spectrophotometry, high-performance liquid chromatography, liquid chromatography-electrospray ionization-tandem mass spectrometry and high-performance thin layer chromatography for their routine, impurity profiling and stability indicating determination in different pharmaceutical matrices.
Keywords: Type 2 diabetes mellitus, sodium-glucose co-transporter inhibitors, analytical methods, SGLT2, inhibitors, glucose.
Graphical Abstract
[2]
Sanagapati, M.; Dhanalaxmi, K.; Reddy, N.; Kavitha, B. Method development and validation of dapagliflozin API by UV spectroscopy. Int. J. Pharm. Sci. Rev. Res., 2014, 27(1), 270-272.
[3]
Karuna, P.C.; China, M.; Eswarah, M.V.; Basaveswara, M.V. Unique UV spectrophotometric method for reckoning of dapagliflozin in bulk and pharmaceutical dosage forms. J. Chem. Pharm. Res., 2015, 7(9), 45-49.
[4]
Mante, G.V.; Gupta, K.R.; Hemke, A.T. Estimation of Dapagliflozin from its tablet formulation by UV-spectrophotometry. Pharm. Methods, 2017, 8(2), 102-107.
[5]
Jani, B.R.; Shah, K.V.; Kapupara, P. Development and validation of UV spectroscopic first derivative method for simultaneous estimation of dapagliflozin and metformin hydrochloride in synthetic mixture. J. Bioequiv., 2016, 1(1), 1-8.
[6]
Patel, A.; Maheshwari, D. Development and validation of UV spectrophotometric method and RP – HPLC method for simultaneous estimation of dapagliflozin propanediol and glimepiride in synthetic mixture. EJPMR, 2017, 4(7), 416-434.
[7]
de Meira, R.Z.C.; Maciel, A.B.; Murakami, F.S.; de Oliveira, P.R.; Bernardi, L.S. In vitro dissolution profile of dapagliflozin: development, method validation, and analysis of commercial tablets. Int. J. Anal. Chem., 2017, 1-6.
[8]
Jeyabaskaran, M.; Rambabu, C.; Dhanalakshmi, B. RP-HPLC method development and validation of dapagliflozin in bulk and tablet formulation. IJPAR, 2013, 2(4), 221-226.
[9]
Sanagapati, M.; Dhanalakshmi, K.; Nagarjunareddy, G.; Sreenivasa, S. Development and validation of a RP-HPLC method for the estimation of dapagliflozin in API. Int. J. Pharm. Sci. Res., 2014, 5(12), 5394-5397.
[10]
Sarkar, S.; Patel, V. Method development and validation of dapagliflozin drug in bulk and tablet dosage form by RP-HPLC. Int. J. Pharma. Res. Health. Sci., 2017, 5(4), 1755-1759.
[11]
Debata, J.; Kumar, S.; Jha, S.K.; Khan, A. RP-HPLC method development and validation of dapagliflozin in bulk and tablet dosage form. Int. J. Drug Dev. Res., 2017, 9(2), 48-51.
[12]
Sabbagh, B.; Lokesh, B.; Akouwah, G.A. Validated RP-HPLC and UV-spectroscopy methods for the estimation of dapagliflozin in bulk and in tablets. Indian Drugs, 2017, 54(3), 44-51.
[13]
Verma, M.; Patel, C.; Patel, M. Development and stability indicating HPLC method for dapagliflozin in API and pharmaceutical dosage form. Int. J. App. Pharmaceut., 2017, 9(5), 33-41.
[14]
Kulsum, S.; Vidyasagar, G.; Mohammed, T. A simple and validated RP-HPLC method for the simultaneous estimation of metformin and dapagliflozin in bulk and pharmaceutical dosage forms. J. Pharmaceut. Med. Chem., 2015, 1(2), 99-104.
[15]
Urooj, A.; Sundar, P.S.; Vasanthi, R.; Raja, M.A.; Dutt, K.R.; Rao, K.N.V.; Ramana, H. Development and validation of RP-HPLC method for simultaneous estimation of dapagliflozin and metformin in bulk and in synthetic mixture. World J. Pharm. Pharm. Sci., 2018, 6(7), 2139-2150.
[16]
Shyamala, N.B.; Kavitha, M. Pooja and Sharma J.V.C., Validated RP-HPLC method for simultaneous estimation of metformin hydrochloride and dapagliflozin in tablet dosage form. Am. J. Biological Pharmaceut. Res., 2015, 2(2), 109-113.
[17]
Deepan, T.; Basaveswara, R.M.V.; Dhanaraju, M.D. Development of validated stability indicating assay method for simultaneous estimation of metformin and dapagliflozin by RP- HPLC. EJAS, 2017, 9(4), 189-199.
[18]
Yunoos, M.; Sankar, G. A validated stability indicating High-Performance Liquid Chromatographic method for simultaneous determination of metformin HCL and dapagliflozin in bulk drug and tablet dosage form. Am. J. Pharm. Clin. Res, 2015, 8(3), 320-326.
[19]
Prameela, K.L.; Veni, P.R.K.; Satyanarayana, P.V.V.; Hari, B.B. Development and validation of stability indicating Reverse Phase High Performance Liquid Chromatography method with photodiode array detection for the simultaneous estimation of hypoglycemic agents, dapagliflozin and metformin. IJPBS, 2017, 8(3), 328-336.
[20]
Seshagiri, S.N.; Rao, J.V.L.N. A stability Indicating RP- HPLC method for simultaneous estimation of dapagliflizon and saxagliptin in combined dosae forms. Inventi. Rapid: Pharm. Analysis Quality Assurance., 2017, 4, 1-11.
[21]
Aubry, A.F.; Gu, H.; Magnier, R.; Morgan, L.; Xu, X.; Tirmenstein, M.; Wang, B.; Deng, Y.; Cai, J.; Couerbe, P.; Arnold, M. Validated LC-MS/MS methods for the determination of dapagliflozin, a sodium-glucose co-transporter 2 inhibitor in normal and ZDF rat plasma. Bioanalysis, 2010, 2(12), 2001-2009.
[22]
Obermeier, S.M. In Vitro characterization and pharmacokinetics of dapagliflozin (BMS-512148), a potent Sodium-Glucose Co transporter Type II Inhibitor, in animals and humans. Drug Metab. Dispos., 2010, 38, 405-414.
[23]
Kumara, C.V.; Aparnab, P.; Kumara, Y.R.; Reddya, G.R. Determination of residual solvents in dapagliflozin amorphous by gas chromatography with static head space method. Der. Pharmacia. Lettre, 2016, 8(9), 349-356.
[24]
Krupaand, B.; Karuna, V. UV and derivative spectrophotometry method for the estimation of canagliflozin in pharmaceutical formulations. Int. J. Applied Sci. Biological Sci., 2017, 6(1), 22-29.
[25]
Krupa, B.; Vani, K. Extractive visible spectrophotometric method development and validation for the estimation of canagliflozin in pharmaceutical formulations. Experiment, 2017, 40(3), 2376-2381.
[26]
Lotfy, H.M.; Mohamed, D.; Elshahed, M.S. Different mathematical processing of absorption, ratio and derivative spectra for quantification of mixtures containing minor component: An application to the analysis of the recently co-formulated antidiabetic drugs; canagliflozin and metformin. Spectrochimica. Acta. Part A. Mol. Bimol. Spectr., 2018, 189(15), 100-109.
[27]
Suma, M.; Manasa, K.; Rajakumari, C.; Lakshmaiah, B. RP - HPLC method development and validation for the estimation of canagliflozin in tablet dosage form. Int. J. Pharm., 2014, 5(4), 1288-1292.
[28]
Ladva, B.J.; Dobariya, P.V.; Pancholi, H.D.; Nayak, B.S.; Jain, S. Development and validation of chromatographic method for estimation of canagliflozin in API and tablet dosage form. Int. J. Recent Sci. Res., 2016, 7(5), 10976-10979.
[29]
Marella, V.L.; Syed, A.; Lakshmi, P.M.; Nalluri, B.N. A novel validated RP-HPLC method for the estimation of canagliflozin. Int. J. Adv. Pharmaceut. Anal., 2017, 7(3), 24-27.
[30]
Jyothi, U.; Umadevi, P. Analytical method development and validation for the simultaneous estimation of canagliflozin and metformin in drug product by RP-HPLC. Eur. J. Biomed. Pharmaceut. Sci., 2017, 4(11), 298-303.
[31]
Trivedi, A.; Dixit, N.; Jhade, D. Modified quantification through high-performance liquid chromatography analysis for canagliflozin and metformin hydrochloride in bulk and tablets using ecofriendly green solvents. Int. J. Appl. Pharmaceut., 2017, 9(5), 97-101.
[32]
Reddy, N.P.; Chevela, N.T. RP-HPLC Method development and validation for the simultaneous estimation of metformin and canagliflozin in tablet dosage form. Int. J. Pharma Sci., 2015, 5(4), 1155-1159.
[33]
Kommineni, V.; Chowdary, K.P.R.; Prasad, S.V.U.M. Development and validation of a new RP-HPLC method for simultaneous estimation of metformin hydrochloride and canagliflozin and its comparison with the reported methods. World J. Pharm. Pharm. Sci., 2017, 6(3), 696-713.
[34]
Gaware, D.; Patil, R.; Harole, M. A Validated Stability Indicating RP-HPLC method for simultaneous determination of metformin and canagliflozin in pharmaceutical formulation. World J. Pharm. Pharm. Sci., 2015, 4(12), 631-640.
[35]
Panigrahy, U.P.; Reddy, A.S.K. A Novel Validated RP-HPLC-DAD Method for the simultaneous estimation of metformin hydrochloride and canagliflozin in bulk and pharmaceutical tablet dosage form with forced degradation studies. Orient. J. Chem., 2015, 31(3), 1489-1507.
[36]
Kommineni, V.; Chowdary, K.P.R.; Prasad, S.V.U.M. Development of a new stability indicating RP-HPLC method for simultaneous estimation of metformin hydrochloride and canagliflozin and its validation as per ICH guidelines. IJPSR, 2017, 8(8), 3427-3435.
[37]
Zaghary, W.A.; Mowaka, S.; Hendy, M.S. Comparative liquid chromatographic study for concurrent determination of canagliflozin and metformin in combined tablets. J. Anal. Methods Chem., 2017, 1-9.
[38]
Bhole, R.P.; Gandhi, J.S.; Wankhede, S.B. Development and validation of HPTLC method for simultaneous estimation of canagliflozin and metformin hydrochloride in bulk and tablet dosage form. South African. Pharm. J., 2017, 84(6), 65-71.
[39]
Dudhe, P.B.; Kamble, M.C. RP-HPLC Method development and validation for the determination of canagliflozin in human plasma. Int. J. Pharm. Tech. Res., 2016, 9(8), 174-181.
[40]
Iqbal, M.; Khalil, N.Y.; Alanazi, A.M.; Al-Rashood, K.A. A simple and sensitive high performance liquid chromatography assay with a fluorescence detector for determination of canagliflozin in human plasma. Anal. Methods, 2015, 7, 2028-2035.
[41]
Kobuchi, S.; Yano, K.; Ito, Y.; Sakaeda, T.; Validated, L.C. MS/MS method for determination of canagliflozin, a sodium glucose co transporter 2 (SGLT-2) inhibitor, a lower volume of rat plasma, an application to pharmacokinetic studies in rats. Biomed. Chromatogr., 2016, 30(10), 1549-1555.
[42]
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(12), 306-312.
[43]
Patil, S.D.; Chaure, S.K.; Kshirsagar, S. Development and validation of UV spectrophotometric method for simultaneous estimation of empagliflozin and metformin hydrochloride in bulk drugs. Asian J. Pharmaceut. Anal., 2017, 7(2), 117-123.
[44]
Godasu, S.K.; Sreenivas, S.A. A new validated RP-HPLC method for the determination of metformin HCl and empagliflozin in its bulk and pharmaceutical dosage forms. IJPSR, 2017, 8(5), 2223-2332.
[45]
Patel, A.M.; Chaudhary, A.B. Stability indicating RP-HPLC method development and validation for estimation of empagliflozin and metformin HCl. World J. Pharm. Pharm. Sci., 2017, 6(9), 872-885.
[46]
Padmaja, N.; Veerabhadram, G. Method development and validation of RP-HPLC method for the estimation of empagliflozin in API. Int. J. Pharm. Sci. Res., 2016, 7(2), 724-727.
[47]
Geetha, S.P.; Lakshmana, R.K.; Prasad, K.; Suresh, B.K. Development and validation of stability indicating reversed phase high pressure liquid chromatography method for simultaneous estimation of metformin and empagliflozin in bulk and tablet dosage form. Asian J. Pharmaceut. Clin. Res., 2016, 9(1), 126-135.
[48]
Surendra, B.; Nataraj, K.S.; Gnananath, K. Method development and validation for the determination of metformin HCL and empagliflozin in its bulk and pharmaceutical dosage forms by RP-ultra performance chromatography method. Int. J. Pharma Bio Sci., 2017, 8(4), 253-258.
[49]
Jaiswal, S.H.; Katariya, M.V.; Katariya, V.R.; Karva, G.S.; Koshe, K. Validated stability indicating HPLC method for determination of process related impurities in empagliflozin drug substances. World J. Pharmaceut. Res., 2017, 6(7), 1025-1037.
[50]
Thakor, N.S.; Amrutkar, S.V. Implementing quality by design (QbD) in chromatography. Austin J. Anal. Pharm. Chem., 2017, 1(1), 1-5.
[51]
Bhole, R.P.; Wankhede, S.B.; Pandey, M. Stability indicating HPTLC method for simultaneous estimation of empagliflozin and linagliptin in pharmaceutical formulation. Anal. Chem. Lett., 2017, 7(1), 76-85.
[52]
Ayoub, B.M.; Mowaka, S. LC-MS/MS determination of empagliflozin and metformin. J. Chromatogr. Sci., 2017, 55(7), 742-747.
Related Journals
Related Books
New Findings from Natural Substances
Pharmaceutical Chemistry and Production: An Introductory Textbook
Evidence-Based Research in Ayurveda against COVID-19 in Compliance with Standardized Protocols and Practices
Pharmaceuticals for Targeting Coronaviruses
Medical Applications of Beta-Glucan
Nanotechnology Driven Herbal Medicine for Burns: From Concept to Application
Postbiotics: Science, Technology and Applications
Biologically Active Natural Products from Asia and Africa: A Selection of Topics
Article Metrics
44
5
1
1