Author(s): Sapna Rathod, Nisarg Patel, Bhupendra Prajapati

Email(s): srathod456@gmail.com

DOI: 10.52711/0974-360X.2025.00626   

Address: Sapna Rathod1*, Nisarg Patel2, Bhupendra Prajapati3,4
1Department of Pharmaceutical Chemistry and Quality Assurance, APMC College of Pharmaceutical Education and Research, Himatnagar, 383001, Gujarat, India.
2Department of Pharmacognosy, APMC College of Pharmaceutical Education and Research, Himatnagar, 383001, Gujarat, India.
3Department of Pharmaceutics, Shree S.K. Patel College of Pharmaceutical Education and Research, Ganpat University, Ganpat Vidyanagar, 384012, Gujarat, India.
4Centre for Research Impact and Outcome, Chitkara College of Pharmacy, Chitkara University, Rajpura, 140401, Punjab, India.
*Corresponding Author

Published In:   Volume - 18,      Issue - 9,     Year - 2025


ABSTRACT:
These are chemometric approaches based on UV measurements like principal component regression (PCR) and partial least-squares regression (PLS) to quantify remogliflozin etabonate (REM) and teneligliptin hydrobromide hydrate (TEN) in a multicomponent tablet dosage form simultaneously. The benefit of the suggested approach is that it can analyze a large number of samples quickly and does not require the costly and time-consuming stages of ratio spectra modes or derivatization for any of the analysis. Full factorial design was used in the development of the calibration and validation sets. By measuring the absorbance in the span of 210–275nm (?? = 4nm) at 16 different wavelengths, the absorption data matrix was created. The models were developed by utilising computer programming such as Minitab 21.3.0 and Microsoft Excel 2019. The linear response was observed in the range of 10 – 50µg/ml and 1 – 40µg/ml for REM and TEN correspondingly. The model output was assessed on the basis of coefficient of determination (R2), root mean square error of cross-validation (RMSECV), root mean square error of calibration (RMSEC) and root mean square error of prediction (RMSEP) value. Analytical figures of merit (FOM) like, selectivity, limit of detection (LOD), sensitivity and limit of quantitation (LOQ), were determined for both PLS and PCR. The RMSEP for PLS Model was found 1.552 and 1.422 for REM and TEN correspondingly. The RMSEP for PCR Model was found 1.1516 and 1.3016 for REM and TEN correspondingly. Hence, the prediction power of PCR is relatively better. The suggested approaches greenness profile was shown by the greenness evaluation tool, which concluded that they were environmentally harmless. Using a greenness assessment tool, the newly created method's green profile was evaluated and compared with prior published spectroscopic approaches. A statistical comparison of the assay results obtained for the suggested approach using the Student's t-test showed no discernible differences between the approaches. The developed models were tested to the marketed dosage form for the content determination of both drugs.


Cite this article:
Sapna Rathod, Nisarg Patel, Bhupendra Prajapati. Evaluation of Greenness assessment of Chemometrics assisted UV Spectrophotometric Method for Simultaneous Estimation of Remogliflozin Etabonate and Teneligliptin Hydrobromide Hydrate in Pharmaceuticals. Research Journal of Pharmacy and Technology. 2025;18(9):4369-6. doi: 10.52711/0974-360X.2025.00626

Cite(Electronic):
Sapna Rathod, Nisarg Patel, Bhupendra Prajapati. Evaluation of Greenness assessment of Chemometrics assisted UV Spectrophotometric Method for Simultaneous Estimation of Remogliflozin Etabonate and Teneligliptin Hydrobromide Hydrate in Pharmaceuticals. Research Journal of Pharmacy and Technology. 2025;18(9):4369-6. doi: 10.52711/0974-360X.2025.00626   Available on: https://www.rjptonline.org/AbstractView.aspx?PID=2025-18-9-46


REFERENCES:
1.    Chatterjee S, Khunti K, Davies MJ. Type 2 diabetes. Lancet. 2017; 389(10085): 2239-2251. https://doi.org/10.1016/S0140-6736(17)30058-2.
2.    El Mouhayyar C, Riachy R, Khalil AB, Eid A, Azar S. SGLT2 Inhibitors, GLP-1 Agonists, and DPP-4 Inhibitors in Diabetes and Microvascular Complications: A Review. Int J Endocrinol. 2020; 2020: 1762164. https://doi.org/10.1155/2020/1762164
3.    Abdul-Ghani MA, Puckett C, Triplitt C, Maggs D, Adams J, Cersosimo E, et al. Initial combination therapy with metformin, pioglitazone and exenatide is more effective than sequential add-on therapy in subjects with new-onset diabetes. Results from the Efficacy and Durability of Initial Combination Therapy for Type 2 Diabetes (EDICT): a randomized trial. Diabetes Obes Metab. 2015; 17(3): 268-75. https://doi.org/10.1111/dom.12417.
4.    American Diabetes Association. 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Medical Care in Diabetes-2020. Diabetes Care. 2020; 43(Suppl 1): S98-S110. https://doi.org/10.2337/dc20-S009
5.    Son C, Makino H, Kasahara M, Tanaka T, Nishimura K, Taneda S, et al. Comparison of efficacy between dipeptidyl peptidase-4 inhibitor and sodium-glucose cotransporter 2 inhibitor on metabolic risk factors in Japanese patients with type 2 diabetes mellitus: Results from the CANTABILE study. Diabetes Res Clin Pract. 2021; 180: 109037. https://doi.org/10.1016/j.diabres.2021.
6.    Mak WY, Nagarajah JR, Abdul Halim H, Ramadas A, Mohd Pauzi Z, Pee LT, et al. Dipeptidyl Peptidase-4 inhibitors use in type II diabetic patients in a tertiary hospital. J Pharm Policy Pract. 2020; 13: 34. https://doi.org/10.1186/s40545-020-00238-y.
7.    Baksh SN, Segal JB, McAdams-DeMarco M, Kalyani RR, Alexander GC, Ehrhardt S. Dipeptidyl peptidase-4 inhibitors and cardiovascular events in patients with type 2 diabetes, without cardiovascular or renal disease. PLoS One. 2020; 15(10): e0240141. https://doi.org/10.1371/journal.pone.0240141.
8.    Kawanami D, Takashi Y, Takahashi H, Motonaga R, Tanabe M. Renoprotective Effects of DPP-4 Inhibitors. Antioxidants (Basel). 2021; 10(2): 246. https://doi.org/10.3390/antiox10020246
9.    Li X, Huang X, Bai C, Qin D, Cao S, Mei Q, et al. Efficacy and Safety of Teneligliptin in Patients with Type 2 Diabetes Mellitus: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Front Pharmacol. 2018; 9: 449. https://doi.org/10.3389/fphar.2018.00449.
10.    Erande S, Sarwardekar S, Desai B. QT/QTc safety and efficacy evaluation of teneligliptin in Indian type 2 diabetes mellitus patients: the "thorough QT/QTc" study (Q-SET study). Diabetes Metab Syndr Obes. 2019; 12: 961-967. https://doi.org/10.2147/DMSO.S202458.
11.    Joshi SS, Singh T, Newby DE, Singh J. Sodium-glucose co-transporter 2 inhibitor therapy: mechanisms of action in heart failure. Heart. 2021; 107(13): 1032-1038. https://doi.org/10.1136/heartjnl-2020-318060.
12.    Scheen AJ. Pharmacokinetic Characteristics and Clinical Efficacy of an SGLT2 Inhibitor Plus DPP-4 Inhibitor Combination Therapy in Type 2 Diabetes. Clin Pharmacokinet. 2017; 56(7): 703-718. https://doi.org/10.1007/s40262-016-0498-9.
13.    Lingvay I. Sodium Glucose Cotransporter 2 And Dipeptidyl Peptidase-4 Inhibition: Promise of a Dynamic Duo. Endocr Pract. 2017; 23(7): 831-840. https://doi.org/10.4158/EP161725.
14.    Beebe KR, Pell RJ, Seasholtz MB. Chemometrics: a practical guide. New York: John Wiley andamp; Sons, Inc; 1998.
15.    Rathod SM, Patel PU. Chemometrics-assisted spectrophotometric method development and validation for simultaneous estimation of emtricitabine, tenofovir alafenamide fumarate, and dolutegravir sodium in dosage form. Journal of Reports in Pharmaceutical Sciences. 2022; 11: 41–50. https://doi.org/10.4103/jrptps.JRPTPS_105_21.
16.    Bachri M, Rizky SS. UV spectrophotometry with chemometric methods for concurrent assays of antihypertensive components in tablets. Research Journal of Pharmacy and Technology. 2023; 16(9): 4314-8. https://doi.org/10.52711/0974-360X.2023.00706.
17.    Gandhi SV, Patil D, Baravkar AA. Comparison of Chemometric assisted UV Spectrophotometric and RP-HPLC Method for the simultaneous determination of Ofloxacin and Tinidazole in their Combined dosage form. Research Journal of Pharmacy and Technology. 2021; 14(11): 5713-8. https://doi.org/10.52711/0974-60X.2021.00993.
18.    Mathew C, Varma S. Green Analytical Methods based on Chemometrics and UV spectroscopy for the simultaneous estimation of Empagliflozin and Linagliptin. Asian Journal of Pharmaceutical Analysis. 2022; 12(1): 43-8. https://doi.org/10.52711/2231-5675.2022.00008
19.    Hoang VD. Chemometrics-assisted Spectrophotometric Determination of Ciprofloxacin and Naphazoline in Eye Drops. Asian Journal of Research in Chemistry. 2014; 7(5): 461-5.
20.    Vashi D, Gamit D. Development and Validation of UV - Spectroscopic Method for simultaneous estimation of Remogliflozin etabonate and Teneligliptin in Bulk and Pharmaceutical dosage form by Simultaneous equation method. World Journal of Pharmaceutical and Life Sciences. 2022; 8: 149–53.
21.    Attimarad M, Venugopala KN, Nair AB, Sreeharsha N, Molina EIP, Kotnal RB, Tratrat C, Altaysan AI, Balgoname AA, Deb PK. Environmental sustainable mathematically processed UV spectroscopic methods for quality control analysis of remogliflozin and teneligliptin: Evaluation of greenness and whiteness. Spectrochim Acta A Mol Biomol Spectrosc. 2022; 278: 121303. https://doi.org/10.1016/j.saa.2022.121303.
22.    Prasanthi T, Rao LA, Uha G. Development and Validation of RP-HPLC Method for Simultaneous Quantification of Remogliflozin and Teneligliptin in Pure and Tablet Dosage Form. International Journal of Research in Pharmacy and Chemistry. 2023; 13: 75–9. https://dx.doi.org/10.33289/IJRPC.
23.    Lad HH, Luhar SV. Narkhede: Simultaneous Estimation of Remogliflozin Etabonate and Teneligliptin Hydrobromide Hydrate in Tablet Dosage Form by RP-HPLC Method. International Journal of Research and Development. 2023; 8(4): 82–90. https://doi.org/10.36713/epra2016. 
24.    Attimarad M, Venugopala KN, Nair AB, Sreeharsha N, Deb PK. Experimental Design Approach for Quantitative Expressions of Simultaneous Quantification of Two Binary Formulations Containing Remogliflozin and Gliptins by RP-HPLC. Separations. 2022; 9(2): 23. https://doi.org/10.3390/separations9020023.
25.    Singh VD, Singh VK, Daharwal SJ. The comparison of two Chemometric Assisted UV Spectrophotometric Techniques with High-performance Liquid Chromatography Methods for simultaneous determination of three Antiemetic drugs used in Chemotherapy Induced Nausea and Vomiting. Research Journal of Pharmacy and Technology. 2021; 14(9): 4815-24. https://doi.org/10.52711/0974-360X.2021.00837
26.    Sutar AS, Mangsule MB. Application of PLS and PCR as multivariate calibration techniques for simultaneous estimation of ofloxacin and ornidazole in binary mixtures. Asian Journal of Pharmaceutical Analysis. 2022; 12(4): 228-32. https://doi.org/10.52711/2231-5675.2022.00037
27.    Gandhi SV, Khairnar PL, Chaudhari AP. Application of Multivariate Calibration Methods for Simultaneous Determination of Drugs in Fixed Dose Combination. Asian Journal of Pharmaceutical Analysis. 2018; 8(1): 1-6. https://doi.org/10.5958/2231-5675.2018.00001.7
28.    Gandhi SV, Sonawane PS. Chemometric-Assisted UV Spectrophotometric Method for Determination of Cefixime Trihydrate and Cloxacillin Sodium in Pharmaceutical Dosage Form. Asian Journal of Research in Chemistry. 2018; 11(4): 705-9. https://doi.org/10.5958/0974-4150.2018.00124.4.
29.    Rathod S, Patel P, Patel N. Chemometrics assisted spectrophotometric method development and validation for simultaneous estimation of abacavir, lamivudine and dolutegravir in dosage form. Indian Journal of Pharmaceutical Education and Research. 2023; 57(2): 570–82. https://doi.org/10.5530/ijper.57.2.70.
30.    Rathod SM, Patel PU. Chemometrics assisted spectroscopic method development and validation for simultaneous determination of sofosbuvir and daclatasvir dihydrochloride in tablet formulation. Indian Drugs. 2020; 57(03): 37–46. https://doi.org/10.53879/id.57.03.12273.
31.    Patel NC, Patel AP, Patel JK. Development and validation of chemometrics assisted UV spectrophotometric method for epigallocatechin gallate and curcumin in tablet formulation. Indian Drugs. 2020; 57: 45–54. https://doi.org/10.53879/id.57.04.12286.
32.    Ragno G, Ioele G, Risoli A. Multivariate calibration techniques applied to the spectrophotometric analysis of one-to-four component systems. Anal Chim Acta. 2004; 512: 173–80. https://doi.org/10.1016/j.aca.2004.02.034.
33.    Haaland DM, Thomas EV. Partial least-squares methods for spectral analyses. 1. Relation to other quantitative calibration methods and the extraction of qualitative information. Anal. Chem. 1988; 60: 1193–202. https://doi.org/10.1021/ac00162a020.
34.    Gałuszka A, Migaszewski ZM, Konieczka P, Namieśnik J. Analytical Eco-Scale for assessing the greenness of analytical procedures. Trends Analyt Chem. 2012 ;37: 61-72. https://doi.org/10.1016/j.trac.2012.03.013
35.    J. Płotka-Wasylka. A new tool for the evaluation of the analytical procedure: green analytical procedure index. Talanta. 2018; 181: 204-09. https://doi.org/10.1016/j.talanta.2018.01.013.
36.    Pena-Pereira F, Wojnowski W, Tobiszewski M. AGREE-Analytical GREEnness Metric Approach and Software. Anal Chem. 2020; 92(14): 10076-10082. https://doi.org/10.1021/acs.analchem.0c01887.
37.    Jain SD, Awasthi A, Gupta AK. Green Chemistry: A Sustainable Path to Environmental Responsibility and Innovation. Asian Journal of Research in Pharmaceutical Sciences. 2024; 14(1): 51-5. https://doi.org/10.52711/2231-5659.2024.00008
38.    Youssef YM, Mahrouse MA, Mostafa EA. Assessment of environmental impact of a novel stability-indicating RP-HPLC method and reported methods for the determination of selexipag in bulk and dosage form: A comparative study using different greenness assessment tools. Microchemical Journal. 2023; 185: 108256. https://doi.org/10.1016/j.microc.2022.108256.
39.    Eltanany BM, Mouhamed AA, Lamie NT, Mostafa NM. Smart multivariate spectrophotometric assisted techniques for simultaneous determination of ephedrine hydrochloride and naphazoline nitrate in the presence of interfering parabens. Curr Pharm Anal. 2021; 17(8): 1104–12. https://doi.org/10.2174/1573412916999200525011749.
40.    International Conference on Harmonization (1996) Technical Requirements for Registration of Pharmaceuticals for Human Use, Validation of Analytical Procedures: Validation of analytical procedures: Text and Methodology, ICH Q2 (R1); 2005.
41.    Escandar GM, Damiani PC, Goicoechea HC, Olivieri AC. A review of multivariate calibration methods applied to biomedical analysis. Microchem J. 2006; 82(1): 29–42. https://doi.org/10.1016/j.microc.2005.07.001.
42.    Olivieri AC, Goicoechea HC, Iñón FA. MVC1: an integrated MatLab toolbox for first- order multivariate calibration. Chemometr Intell Lab Syst. 2004; 73–189. https://doi.org/10.1016/j.chemolab.2004.03.004.
43.    Olivieri AC, Faber NM, Ferré J, Boqué R, Kalivas JH, Mark H. Uncertainty estimation and figures of merit for multivariate calibration (IUPAC Technical Report). Pure Appl Chem. 2006; 78(3): 633–61. https://doi.org/10.1351/pac200678030633.


Recomonded Articles:

Research Journal of Pharmacy and Technology (RJPT) is an international, peer-reviewed, multidisciplinary journal.... Read more >>>

RNI: CHHENG00387/33/1/2008-TC                     
DOI: 10.5958/0974-360X 

1.3
2021CiteScore
 
56th percentile
Powered by  Scopus


SCImago Journal & Country Rank

Journal Policies & Information


Recent Articles




Tags


Not Available