Open Access Open Access  Restricted Access Subscription Access
Open Access Open Access Open Access  Restricted Access Restricted Access Subscription Access

Estimation and Validation of Remogliflozin Etabonate in Dosage form and in Bulk Drug by Spectrophotometeric Method


Affiliations
1 Department of Pharmaceutical Chemistry, MMU College of Pharmacy, Ramanagar - 562159 Karnataka, India, India
     

   Subscribe/Renew Journal


A simple, sensitive, accurate, rapid and economical Spectrophotometric method was developed for estimation and validation of Remogliflozin Etabonate in pure drug and tablet dosage form. The absorbance was measured at 239.8nm using Ethanol as solvent system. It obeyed Beer’s law at the concentration range of 2-14µg/ml with coefficient of correlation (r2) of 0.997. Limit of detection (LOD) was found to be 1.220µg/ml and Limit of quantitation (LOQ) was found to be 5.220µg/ml. The proposed analytical method was validated according to ICH guidelines, yielded good results concerning range, linearity, precision, accuracy, robustness and ruggedness.

Keywords

Remogliflozin Etabonate, Type II diabetes, Spectrophotometry, Ethanol, Method validation
Subscription Login to verify subscription
User
Notifications
Font Size


  • Statement on a nonproprietory name adopted by the USAN council
  • "Avolynt Announces Completion of Phase 2b BRID Study of SGLT2 Inhibitor Remogliflozin-Etabonate" (Press release). Avolynt, Inc. Retrieved July 24, 2018.
  • S Mudaliar, AD Armstrong, AA Mavian, R Semmes Connor O, KP Mydlow, J Ye, et al. (November 2012). "Remogliflozin Etabonate, a selective inhibitor of the sodium-glucose transporter 2, improves serum glucose profiles in type I diabetes". Diabetes Care. 35 (11): 2198–200. doi:10.2337/dc12-0508. PMC 3476920.PMID 23011728.
  • RL Dobbins, R Semmes Connor O, A Kapur, C Kapitza, G Golor, I Mikoshiba, et al. (January 2012). "Remogliflozin Etabonate, a selective inhibitor of the sodium-dependent transporter II reduces serum glucose in typeII diabetes mellitus patients". Diabetes, Obesity and Metabolism. 14 (1): 15–22. doi:10.1111/j.14631326.2011.01462.x. PMID 21733056.S2CID 23372554.
  • PA Sykes, R Semmes Connor O, R Dobbins, JD Dorey, DJ Lorimer, S Walker, et al. (January 2015). "Randomized trial showing efficacy and safety of twice-daily Remogliflozin Etabonate for the treatment of type II diabetes". Diabetes, Obesity and Metabolism. 17 (1): 94–7. doi:10.1111/dom.12391. PMID 25223369.S2CID 6436562.
  • PA Sykes, LG Kemp, R Dobbins, R Semmes Connor O, RS Almond, OW Wilkison, et al. (January 2015). "Randomized efficacy and safety trial of once-daily Remogliflozin Etabonate for the treatment of type II diabetes". Diabetes, Obesity and Metabolism. 17 (1): 98–101. doi:10.1111/dom.12393. PMID 25238025.S2CID 25280330.
  • "Molecule of the Month: Dapagliflozin". Prous Science. November 2007. Archived from the original on January 6, 2008.
  • S Nakano, K Katsuno, M Isaji, T Nagasawa, B Buchrer, S Walker, W O Wilkison, B Cheatham. Journal of Clinical and Experimental Hepatology, 2015;5(3):190-198
  • Y Fujimori, K Katsuno, I Nakashim. Remogliflozin Etabonate, in a novel category of selective low-affinity sodium glucose cotransporter (SGLT2) inhibitors, exhibits antidiabetic efficacy in rodent models. J. Pharmacol. Exp. Ther. 2008;327(1):268-276
  • 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):2042-2044
  • Swapna J, Madhu C, Srivani M, Sumalatha M, Nehalatha Y, Anusha Y. Analytical method Development and Method Validation for the Simultaneous Estimation of Metformin Hydrochloride and Pioglitazone Hydrochloride in Tablet Dosage Form by RP-HPLC, Asian Journal of Pharmaceutical Analysis.
  • ;2(3):85-89
  • Vichare V, Suryawanshi P, Bhosale J, Dhole S. Simultaneous estimation of Metformin HCl and Pioglitazone HCl by Second Order Derivative UV- Visible Spectrophotometric Method in Tablet Formulation, Asian Journal of Pharmaceutical Analysis.2014;4(3):121-124
  • Sri VK, Anusha M, Reddy RS. A rapid RP-HPLC Method Development and Validation for the Analysis of Linagliptinin Bulk and Pharmaceutical Dosage Form, Asian Journal of Pharmaceutical Analysis, 2015;5(1):16-20
  • Pawar J, Sonawane S, Chhajed S, Kshirsagar S. Development and Validation of RP-HPLC Method for Simultaneous Estimation of Metformin HCl and Gliclazide, Asian Journal of Pharmaceutical Analysis. 2016; 6(3):151-154
  • Rao VB, Vijetha P, Vidyadhara S, Kavita K. A Novel RP-HPLC Method Development and Validation for the Determination of Pioglitazone and Glimepride in Bulk and Pharmaceutical Formulations, Asian Journal of Pharmaceutical Analysis. 2017; 7(3): 145-150
  • Gadge SS, Nakod DA, Wasnik PV, Gatkine MT, Zile SS, Mohije HN, Salode LV. Development and Validation of Q-absorbance Ratio method for Simultaneous Estimation of Teniligliptin hydrobromide and Metformin HCl in Multicomponent Dosage form. Asian Journal of Pharmaceutical Analysis, 2019; 9(4): 215218
  • Venkatesh S, Jyothi S, Chiluka R, Padmavati Y. Development of UV-Spectrophotometric Method for the Simultaneous Estimation of Nateglinide and Piperine in combined tablet dosage form. Asian
  • Journal of Pharmaceutical Analysis. 2020; 10(3): 134-140
  • Farkade K, Tawar M. Analytical Method Validation and Quantitative Analysis for Active Pharmaceutical Ingredient and Marketed Formulation of Teniligliptin Hydrobromide by UV Spectroscopy. Asian Journal of Pharmaceutical Analysis. 2021; 11(3): 195-8
  • More SS, Sonawane SS, Chhajed SS, Kshirsagar JS. Development and Validation of RP-HPLC Method for Simultaneous Estimation of Saxagliptin and Dapagliflozin in Tablets. Asian Journal of
  • Pharmacy and Technology. 2018; 8(3):145-148
  • Harikrishnan N, Murali Krishna U, Shaik B, Bhavsar V, V Manjusha, Kumar RV. Development and Validation of UVSpectrophotometric Method of Glibenclamide (Glyburide) in Bulk and Pharmaceutical Formulations. Asian Journal of Research in
  • Chemistry. 2010; 3(2): 316-318 .

Abstract Views: 67

PDF Views: 0




  • Estimation and Validation of Remogliflozin Etabonate in Dosage form and in Bulk Drug by Spectrophotometeric Method

Abstract Views: 67  |  PDF Views: 0

Authors

Husnain Fathima
Department of Pharmaceutical Chemistry, MMU College of Pharmacy, Ramanagar - 562159 Karnataka, India, India
Nirmal. T. Havannavar
Department of Pharmaceutical Chemistry, MMU College of Pharmacy, Ramanagar - 562159 Karnataka, India, India
Afnaz Jahan
Department of Pharmaceutical Chemistry, MMU College of Pharmacy, Ramanagar - 562159 Karnataka, India, India

Abstract


A simple, sensitive, accurate, rapid and economical Spectrophotometric method was developed for estimation and validation of Remogliflozin Etabonate in pure drug and tablet dosage form. The absorbance was measured at 239.8nm using Ethanol as solvent system. It obeyed Beer’s law at the concentration range of 2-14µg/ml with coefficient of correlation (r2) of 0.997. Limit of detection (LOD) was found to be 1.220µg/ml and Limit of quantitation (LOQ) was found to be 5.220µg/ml. The proposed analytical method was validated according to ICH guidelines, yielded good results concerning range, linearity, precision, accuracy, robustness and ruggedness.

Keywords


Remogliflozin Etabonate, Type II diabetes, Spectrophotometry, Ethanol, Method validation

References