Review on Method Development and Validation of Remogliflozin Etabonate and Teneligliptin by RP-HPLC and UV Spectroscopy
DOI:
https://doi.org/10.22270/ajprd.v13i4.1598Abstract
The increasing global prevalence of Type 2 Diabetes Mellitus has driven the demand for safer and more effective therapeutic strategies, notably those combining novel antidiabetic agents. This study focuses on Remogliflozin Etabonate, a selective SGLT2 inhibitor, and Teneligliptin, a third-generation DPP-4 inhibitor, both offering complementary mechanisms for improved glycemic control. The research emphasizes the urgent need for robust analytical methods to ensure quality, safety, and efficacy of these drugs in pharmaceutical formulations. Various validated techniques including UV Spectroscopy, HPTLC, and RP-HPLC have been developed to accurately quantify these compounds. Among these, RP-HPLC stands out for its precision, reproducibility, and adaptability in routine analysis. Detailed method validation parameters such as linearity, accuracy, LOD, and LOQ are examined, supporting their compliance with ICH guidelines. This paper also compares the performance and suitability of existing methods while proposing optimal conditions for simultaneous estimation. The combination of Remogliflozin and Teneligliptin not only enhances therapeutic outcomes but also poses analytical challenges that are addressed through methodical development. The review underscores the significance of validated techniques in regulatory submissions and quality assurance, paving the way for advanced pharmacological monitoring. This comprehensive overview contributes to the evolving landscape of diabetes treatment and analytical innovation.
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Patel R, Kotadiya R. Stability-indicating green HPLC method for fixed-dose containing remogliflozin etabonate and teneligliptin: an AQbD approach. Drug Development and Industrial Pharmacy. 2024 Aug tablets 2;50(8):750-62.
Devi DV, Dindigala AK, Makineni A, Anitha P. Stability Indicating RP-HPLC Method for Remogliflozin and Teneligliptin.
Shambharkar S, Tonde R, Nilkhan S, Charhate S, Ahmad W. Remogliflozin etabonate (Re) the latest addition to the SGLT2 inhibitor. Asian Journal of Pharmacy and Technology. 2024;14(1):16-22.
Tewari J, Qidwai KA, Rana A, Tewari A, Tewari V, Maheshwari A. Safety and Efficacy of Remogliflozin in People With Type 2 Diabetes Mellitus: A Systematic Review and Meta-Analysis. Cureus. 2024 Aug 4;16(8):e66145.
Shinde S, Avhad S, Morkar V, Patki C, Chikhale H, Borse L. Overview on remogliflozin SGLT-2 inhibitor in the management of type-2 diabetic mellitus in human beings. Bulletin of the Karaganda university Biology. Medicine. Geography series. 2023 Dec 28;112(4):156-67.
Fujimori Y, Katsuno K, Nakashima I, Ishikawa-Takemura Y, Fujikura H, Isaji M. Remogliflozin etabonate, in a novel category of selective low-affinity sodium glucose cotransporter (SGLT2) inhibitors, exhibits antidiabetic efficacy in rodent models. Journal of Pharmacology and Experimental Therapeutics. 2008 Oct 1;327(1):268-76.
Dharmalingam M, Aravind SR, Thacker H, Paramesh S, Mohan B, Chawla M, Asirvatham A, Goyal R, Shembalkar J, Balamurugan R, Kadam P. Efficacy and safety of remogliflozin etabonate, a new sodium glucose co-transporter-2 inhibitor, in patients with type 2 diabetes mellitus: a 24-week, randomized, double-blind, active-controlled trial. Drugs. 2020 Apr;80:587-600.
Kapur A, O’Connor-Semmes R, Hussey EK, Dobbins RL, Tao W, Hompesch M, Smith GA, Polli JW, James Jr CD, Mikoshiba I, Nunez DJ. First human dose-escalation study with remogliflozin etabonate, a selective inhibitor of the sodium-glucose transporter 2 (SGLT2), in healthy subjects and in subjects with type 2 diabetes mellitus. BMC Pharmacology and Toxicology. 2013 Dec;14:1-1.
Guariguata L, Whiting D, Weil C, Unwin N. The International Diabetes Federation diabetes atlas methodology for estimating global and national prevalence of diabetes in adults. Diabetes research and clinical practice. 2011 Dec 1;94(3):322-32.
Dobbins RL, O’Connor‐Semmes R, Kapur A, Kapitza C, Golor G, Mikoshiba I, Tao W, Hussey EK. Remogliflozin etabonate, a selective inhibitor of the sodium‐dependent transporter 2 reduces serum glucose in type 2 diabetes mellitus patients. Diabetes, Obesity and Metabolism. 2012 Jan;14(1):15-22.
Maladkar M, Sankar S, Kamat K. Teneligliptin: heralding change in type 2 diabetes. Journal of Diabetes mellitus. 2016;6(02):113.
Ranakishor P, Kongara S, Jithendra C, Rasheed Ahemad S, Lavanya R, Vanitha Rani N. Glycemic and non-Glycemic effects of teneligliptin. Journal of Pharmaceutical Research International. 2020;32(6):51-63.
Li X, Huang X, Bai C, Qin D, Cao S, Mei Q, Ye Y, Wu J. Efficacy and safety of teneligliptin in patients with type 2 diabetes mellitus: a systematic review and meta-analysis of randomized controlled trials. Frontiers in Pharmacology. 2018 May 4;9:449.
Karthickeyan K, Saara AF, Gopal K, Karthick S, Ashi AN. A Review on Glimepiride vs Teneligliptin as a Second-Line Drug for the Treatment of Type 2 Diabetes Mellitus. Journal Of Education And Scientific Medicine. 2023 Sep 13;2(3):73-9.
Sunitha PG, Karthikeyan R, Kumar BR, Muniyappan S. Validated colorimetric methods for the estimation of teneligliptin in tablets. Journal of Drug Delivery and Therapeutics. 2017 Jul 15;7(4):38-40.
Sagara M, Suzuki K, Aoki C, Tanaka S, Taguchi I, Inoue T, Aso Y. Impact of teneligliptin on oxidative stress and endothelial function in type 2 diabetes patients with chronic kidney disease: a case–control study. Cardiovascular Diabetology. 2016 Dec;15:1-0.
Kadowaki T, Marubayashi F, Yokota S, Katoh M, Iijima H. Safety and efficacy of teneligliptin in Japanese patients with type 2 diabetes mellitus: a pooled analysis of two Phase III clinical studies. Expert Opinion on Pharmacotherapy. 2015 May 3;16(7):971-81.
VinendraParmar M. Assessment of efficacy and safety of teneligliptin in patients with type 2 diabetes mellitus having hypertension/dyslipidemia (Doctoral dissertation, Nirma University).
Nakamaru Y, Akahoshi F, Iijima H, Hisanaga N, Kume T. Tissue distribution of teneligliptin in rats and comparisons with data reported for other dipeptidyl peptidase‐4 inhibitors. Biopharmaceutics & drug disposition. 2016 Apr;37(3):142-55.
Eto T, Inoue S, Kadowaki T. Effects of once‐daily teneligliptin on 24‐h blood glucose control and safety in Japanese patients with type 2 diabetes mellitus: a 4‐week, randomized, double‐blind, placebo‐controlled trial. Diabetes, Obesity and Metabolism. 2012 Nov;14(11):1040-6.
Kumar SD, Kumar DH. Importance of RP-HPLC in analytical method development: a review. International journal of pharmaceutical sciences and research. 2012 Dec 1;3(12):4626
Swartz ME, Krull IS. Analytical method development and validation. CRC press; 2018 Oct 3
Sharma S, Goyal S, Chauhan K. A review on analytical method development and validation. International Journal of Applied Pharmaceutics. 2018 Nov 7;10(6):8-15.
Breaux J, Jones K, Boulas P. Analytical methods development and validation. Pharm. Technol. 2003;1:6-13.
Ravisankar P, Navya CN, Pravallika D, Sri DN. A review on step-by-step analytical method validation. IOSR J Pharm. 2015 Oct;5(10):7-19.
Kirthi A, Shanmugam R, Prathyusha MS, Basha DJ. A review on bioanalytical method development and validation by RP-HPLC. Journal of global trends in pharmaceutical sciences. 2014;5(4):2265-71.
Meduri MP, Agarwal P, Vimala G, Banu N. The development and validation studies of RP-HPLC method–A review. World Journal of Pharmaceutical Sciences. 2016 Jan 1:85-92.
Verma G, Mishra M. Development and optimization of UV-Vis spectroscopy-a review. World J. Pharm. Res. 2018 Apr 19;7(11):1170-80.
Vidhi D, Patel P. Method development and validation of UV spectrophotometric estimation of remogliflozin etabonate in bulk and its tablet dosage form. Research Journal of Pharmacy and Technology. 2021;14(4):2042-4.
Shah DA, Gondalia II, Patel VB, Mahajan A, Chhalotiya UK. Stability indicating liquid chromatographic method for the estimation of remogliflozin etabonate. J. Chem. Metrol. 2020 Jul 1;14(2):125-32
Jadhav SR, Deshpande PB, Swami S, Supe D. A validated stability indicating high performance thin layer chromatographic method for determination of remogliflozin etabonate in tablet dosage form. Int J Chem Tech Res. 2021 Jun;14(3):382-90.
Lokhande DP. Analytical method development and validation of teneligliptin by using RP-HPLC with ICH guidelines. Int J Trend Sci Res Dev. 2019 Mar;3(3):2456-6470.
Yadav N, Goyal A. Method development and validation of Teneligliptin in pharmaceutical dosage form by UV spectrophotometric methods. International Journal of Pharmaceutical Chemistry and Analysis. 2017;4(3):54-8.
Patel BD, Dharsandiya NJ, Chaudhary A. Development and Validation of RP-HPLC Method for Estimation of Teneligliptin and its Impurity in Tablet. Int J Pharm Sci Rev Res. 2021;69(2)
Park JW, Kim KA, Park JY. Development of a liquid chromatography/tandem‐mass spectrometry assay for the simultaneous determination of teneligliptin and its active metabolite teneligliptin sulfoxide in human plasma. Biomedical Chromatography. 2020 Feb;34(2):e4721
Tighare KV, Sawale AV. Method Development, Validation and Stress Degradation Study of Teneligliptin by RP-HPLC. Am J Pharm Tech Res. 2021;11:36-50.
Swathi L. Stability indicating RP-HPLC method for simultaneous estimation of remogliflozin and teneligliptin. World Journal of Pharmaceutical Sciences. 2023.
Pooja G. Analytical Method Development And Validation For Simultaneous Estimation Of Remogliflozin And Teneligliptin In Pharmaceutical Dosage Forms By HPLC. World Journal of Pharmaceutical Sciences. 2025.
Menda J, Chintala V, Kanuparthy PR, Katari NK, Kowtharapu LP, Jonnalagadda SB. Quality by Design Tool Assessed Ultraperformance Liquid Chromatography Method for the Analysis of Remogliflozin and Teneligliptin in Oral Dosage Form. ACS omega. 2024 Mar 7;9(11):12553-63.
Jahnavi K, Sudhakar M, Parthiban C, Dixit DC. RP-HPLC Method Validation for The Simultaneous Estimation of Remogliflozin and Teneligliptin in Bulk and Pharmaceutical Dosage Form
Attimarad M, Venugopala KN, Shafi S, Balgoname AA, Altaysan AI. Smart spectrophotometric method development for simultaneous estimation of antidiabetic drugs in formulations. Indian Journal of Pharmaceutical Education and Research; Vol. 56, Issue 1. 2022 Jan 12.
Trivedi SV. Stability Indicating Rp-HPLC Method Development and Validation for Simultaneous Estimation of Remogliflozin Etabonate and Metformin HCL in Synthetic Mixture and Tablet Dosage Form. World Journal of Pharmaceutical Research. 2021 Jun 15;10(10).
Dhara V, Hetvi C. Development and validation of high performance liquid chromatograohy method for simultaneous estimation of remogliflozin etabonate and vildagliptin in pharmaceutical dosage form. Int J Pharm Science Review and research. 2022 Jun 5;2(11):611-22.
Patel VA, Pandya CV, Patel ZJ, Patel DR, Pandya AC. Development and validation of novel RP-UHPLC/DAD methods for simultaneous quantification of remogliflozin and metformin in bulk and formulation. Rasayan J Chem. 2021 Apr 1;14(2):1384-93.
Attimarad M, Nair AB, Nagaraja S, Aldhubiab BE, Venugopala KN, Pottathil S. Smart UV derivative spectrophotometric methods for simultaneous determination of metformin and remogliflozin: development, validation and application to the formulation. Indian J Pharm Educ Res. 2021 Jan 1;55(1):S293-302.
Mandale DA, Shah C, Jatt R. Development and Validation of Novel RP-HPLC Method for the Simultaneous Determination of Remogliflozin and Vildagliptin in Bulk and in synthetic Mixture. Journal of Pharmaceutical Research International. 2021 Aug 14;33(40B):338-49.
Maruthi R, Chandan RS, Barath M, Datta GN, D'silva M, Kumari KM, Ahmad F, Geetha R. Analytical method development and validation of teneligliptin by UV spectroscopy. Research Journal of Pharmacy and Technology. 2021;14(1):75-8.
Pooja G. Analytical method development and validation for simultaneous estimation of remogliflozin and teneligliptin in pharmaceutical dosage forms by HPLC. World Journal of Pharmaceutical Sciences. 2025.
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