Author(s): Amitkumar J. Vyas, Chirag D. Jadav, Krupali J. Patel, Rakshit Patel, Harshal M. Vadile, Ashok B. Patel, Ajay I. Patel, Ashvin Dudhrejiya

Email(s): rxchiragjadav@gmail.com

DOI: 10.52711/0974-360X.2024.00153   

Address: Amitkumar J. Vyas1, Chirag D. Jadav1*, Krupali J. Patel1, Rakshit Patel2, Harshal M. Vadile1, Ashok B. Patel3, Ajay I. Patel1, Ashvin Dudhrejiya1
1B. K. Mody Government Pharmacy College, Rajkot - 360003, Gujarat, India.
2Piramal Pharma Ltd, Ahmedabad - 382220, Gujarat, India.
3Government Pharmacy College, Gandhinagar.
*Corresponding Author

Published In:   Volume - 17,      Issue - 3,     Year - 2024


ABSTRACT:
A simple, rapid, accurate, precise, and reproducible diode array detector-based RP-UPLC method for simultaneous estimation of dapagliflozin propanediol monohydrate and metformin hydrochloride in bulk and tablet dosage form has been developed and validated. The chromatographic analysis was carried out using Acquity UPLC HSS T3 C18 (50 × 2.1mm, 1.8µm) column with a mobile phase consisting of orthophosphoric acid (pH 3.00) and acetonitrile (55:45% V/V) in the isocratic mode, at a flow rate of 0.2mL/min, and eluents were the simultaneous measurement of dapagliflozin propanediol monohydrate and metformin hydrochloride in bulk and tablet dosage form using a diode array detector-based RP-UPLC technique has been developed and validated. The chromatographic analysis was carried out using an Acquity UPLC HSS T3 C18 (50 2.1mm, 1.8 m) column and an orthophosphoric acid (pH 3.00) and acetonitrile (55:45% V/V) mobile phase in the isocratic mode.at a flow rate of 0.2mL/min. Eluents were measured at 222nm. Metformin hydrochloride and dapagliflozin propanediol monohydrate were shown to have retention times of 0.845 minutes and 1.889 minutes, respectively. The linearity was established in the range of 5-15µg/mL for dapagliflozin propanediol monohydrate and 250-750µg/mL for metformin hydrochloride, which had a regression coefficient (r2) greater than 0.999. The % Recovery was found to be 98.77% - 99.57% and 99.15% -101.2% for dapagliflozin propanediol monohydrate and metformin hydrochloride respectively. In a short period,a larger number of samplescan be analyzed due to their short retention time and, therefore, will be economical for routine analysis in the pharmaceutical industry.


Cite this article:
Amitkumar J. Vyas, Chirag D. Jadav, Krupali J. Patel, Rakshit Patel, Harshal M. Vadile, Ashok B. Patel, Ajay I. Patel, Ashvin Dudhrejiya. Diode Array Detector Based RP-UPLC Method for Simultaneous Estimation of Dapagliflozin Propanediol Monohydrate and Metformin. Research Journal of Pharmacy and Technology. 2024; 17(3):991-996 doi: 10.52711/0974-360X.2024.00153

Cite(Electronic):
Amitkumar J. Vyas, Chirag D. Jadav, Krupali J. Patel, Rakshit Patel, Harshal M. Vadile, Ashok B. Patel, Ajay I. Patel, Ashvin Dudhrejiya. Diode Array Detector Based RP-UPLC Method for Simultaneous Estimation of Dapagliflozin Propanediol Monohydrate and Metformin. Research Journal of Pharmacy and Technology. 2024; 17(3):991-996 doi: 10.52711/0974-360X.2024.00153   Available on: https://rjptonline.org/AbstractView.aspx?PID=2024-17-3-4


REFERENCES:
1.    Urooj A. Development and Validation of RP-HPLC Method FOR Simultaneous Estimation of Dapagliflozin and METFORMIN IN bulk and IN Synthetic Mixture. World Journal of Pharmacy and Pharmaceutical Sciences. 2017; 2139–2150. https://doi.org/10.20959/wjpps20177-9657
2.    Lu, Y. T., Ma, X. L., Xu, Y. H., Hu, J., Wang, F., Qin, W. Y., and Xiong, W. Y. A Fluorescent Glucose Transport Assay for Screening SGLT2 Inhibitors in Endogenous SGLT2-Expressing HK-2 Cells. Natural Products and Bioprospecting. 2019; 9(1): 13–21. https://doi.org/10.1007/s13659-018-0188-4
3.    US Pharmacopoeia, NF 34, The United State Pharmacopoeias Convention Inc, Rockville, 2016, Volume-III, pp 4764.
4.    Vogt, J. A., Wachter, U., Wagner, K., Calzia, E., Gröger, M., Weber, S., Wagner, F. Effects of glycemic control on glucose utilization and mitochondrial respiration during resuscitated murine septic shock. Intensive Care Medicine Experimental. 2014; 2(1). https://doi.org/10.1186/2197-425X-2-19
5.    Kuecker, C. M., and  Vivian, E. M. Patient considerations in type 2 diabetes – Role of combination dapagliflozin–metformin XR. Diabetes, Metabolic Syndrome and Obesity: Targets and Therapy. Dove Medical Press Ltd. 2016; 8(2) https://doi.org/10.2147/DMSO.S81565
6.    Vyas, A.J., Rathod, N., Patel, A.I., Prajapati, R., Patel, N.K., Patel, A.B. Analytical Method Development and Validation of Stability Indicating Method and Related Substance by Using RP-HPLC Of Drug Substance. Pharma Science Monitor. 2017; 8(2): 409-419.
7.    Patel, A.I., Prajapati, K.B., Vyas, A.J., Patel, A.B., Patel, N.K. Determination and validation of phthalate impurities in milk by UV-spectrophotometry method. Pharma Science Monitor. 2021; 10(4): 49-58
8.    Patel, A.B., Bundheliya, A.R., Vyas, A.J., Patel, N.K., Patel, A.I. A Review on Metal Impurities in Pharmaceutical. Asian Journal of Pharmaceutical Analysis. 2021; 11(3): 212-222. DOI:10.52711/2231- 5675.2021.00038
9.    Patel, A.B., Asnani, A.H., Vyas, A.J., Patel, N.K., Patel, A.I. A brief review on genotoxic impurities in pharmaceuticals. Asian Journal of Pharmaceutical Research. 2021; 11(3):187-193.
10.    Vyas, A.J., Godhaniya, J.P., Patel, A.I., Patel, A.B., Patel, N.K., Chudasama, A., Shah, S.R. A review on carcinogenic impurities found in marketed drugs and strategies for its determination by analytical methods. Asian Journal of Pharmaceutical Analysis. 2021; 11(2): 159 – 169.
11.    Patel, A.I., Prajapati, K.B., Vyas, A.J., Patel, A.B., Patel, N.K. Determination and validation of phthalate impurities in milk by UV-spectrophotometry method. Pharma Science Monitor. 2021; 10(4): 49-58.
12.    Patel, A.B., Asnani, A.H., Vyas, A.J., Patel, N.K., Patel, A.I. A brief review on genotoxic impurities in pharmaceuticals. Asian Journal of Pharmaceutical Research. 2021; 11(3): 187-193
13.    Vyas, A.J., Patel, S.M., Patel, A.B., Patel, A.I., Patel, N.K. Stability testing: An Essential study for Vaccine Formulation Development. Asian Journal of Pharmaceutical Analysis. 2022; 12(1): 29-6.
14.    Vyas, A.J., Visana, N.M., Patel, A.I., Patel, A.B., Patel, N.K. Analytical Quality by Design in Stress Testing or Stability - Indicating Method. Asian Journal of Pharmaceutical Analysis. 2021; 11(2): 170-178. DOI: 10.52711/2231-5675.2022.00023
15.    Vyas, A.J., Gol, D.A., Patel, A.I., Patel, A.B., Patel, N.K., Chavda, J.R., Lumbhani, A., Chudasama, A. Implementing Analytical Quality by Design (AQbD) Approach for Simultaneous Estimation of Tadalafil and Macitentan by RP-HPLC Method. Analytical Chemistry Letters. 2021; 11(4): 539-552. DOI:10.1080/22297928.2021.1938215.
16.    Patel, A.I., Prajapati, A.B., Jolapara, S.H., Vyas, A.J., Patel, A.B., Patel, N.K., Pandey, M.M. RP-HPLC method for determination of gemfibrozil using central composite design (CCD). Research Journal of Pharmacy and Technology. 2021; 14(6): 3009- 3014. DOI: 10.52711/0974-360X.2021.00527
17.    BG, R., KumarRA, SD, S., A, G., M, S., RSHT, M., and  CPB, S. A Novel Stability-Indicating Method for the Simultaneous Estimation of Saxagliptin and Dapagliflozin in Rat Serum by Using UV Spectroscopy. Pharmaceutica Analytica Acta. 2018; 9(3). https://doi.org/10.4172/2153-2435.1000579
18.    Vyas, A.J., Jha, S.A., Patel, A.B., Patel, A.I., Shah, S.R. Review on simultaneous equation method (Vierodt's method). Asian Journal of Pharmaceutical Analysis. 2022; 12(2): 149-156. DOI: 10.52711/2231-5675.2022.00026
19.    Doredla, N. R., and Mannepalli, C. Method development and validation of RP-HPLC method for simultaneous analysis of three component tablet formulation containing metformin hydrochloride, pioglitazone hydrochloride and glibenclamide. International Journal of PharmTech Research. 2012; 4(3): 948–956. https://doi.org/10.31032/ijbpas/2022/11.5.5861
20.    Gadapa, N., and  Tripathi, U. M. RP-HPLC analytical method development and validation for simultaneous estimation of two drugs Nitazoxanide, Ofloxacin and its pharmaceutical dosage forms. International Journal of ChemTech Research. 2012; 4(2): 775–783
21.    Khan, B., Abdul-Shakoor, Nawaz, S., and  Altaf, A. Development and validation of type-2 diabetes drug in combination (metformin and glibenclamide) by HPLC. Asian Journal of Chemistry. 2011; 23(8): 3347–3349.
22.    Soni, L. K., Narsinghani, T., and  Jain, M. Development and validation of rp-hplc method for simultaneous estimation of metformin hydrochloride and repaglinide in tablet dosage form. Journal of Liquid Chromatography and Related Technologies. 2012; 35(3): 385–392. https://doi.org/10.1080/10826076.2011.601492
23.    Pawar, S. P., Meshram, G. A., and Phadke, M. U. Simultaneous LC estimation of glimepiride and metformin in glimepiride immediate release and metformin sustained release tablets. Chromatographia. 2008; 68(11–12): 1063–1066. https://doi.org/10.1365/s10337-008-0802-4
24.    Deepan, T., and Dhanaraju, M. D. Stability indicating HPLC method for the simultaneous determination of dapagliflozin and saxagliptin in bulk and tablet dosage form. Current Issues in Pharmacy and Medical Sciences. 2018; 31(1): 39–43. https://doi.org/10.1515/cipms-2018-0009
25.    Konari, S. N., and  Jacob, J. T. Stability indicating validated RP-HPLC technique for the analysis of multicomponent anti-diabetic drug combos in pharmaceutical dosage forms. Karbala International Journal of Modern Science. 2015; 1(1): 39–48. https://doi.org/10.1016/j.kijoms.2015.06.002
26.    Udaykumar Rao, B., and Nikalje, A. P. Determination of gliclazide in a tablet dosage form in the presence of metformin hydrochloride by ion pair- Reversed phase liquid chromatographic technique. African Journal of Pharmacy and Pharmacology. 2011; 5(11): 1331–1337. https://doi.org/10.5897/ajpp10.106
27.    Reddy, S., Ahmed, I., Ahmad, I., Mukhopadhyay, A., and Thangam, S. Development and validation of a method for simultaneous estimation of metformin and sitagliptin in human plasma by LC-MS-MS and its application in a bioequivalence study. Journal of Chromatographic Science. 2015; 53(9): 1549–1556. https://doi.org/10.1093/chromsci/bmv055
28.    AF, A., H, G., R, M., L, M., X, X., M, T., M, A. Validated LC–MS/MS methods for the determination of dapagliflozin, a sodium-glucose co-transporter 2 inhibitor in normal and ZDF rat plasma. Bioanalysis. 2001; 2(12): 2001–2009.
29.    Patel, A.I., Ram, K., Guttikar, S., Vyas, A.J., Patel, A.B., Patel, N.K., Trivedi V. Rapid, sensitive and simple LC-MS/MS method development and validation for estimation of phenytoin in human plasma by using deuterated internal standard. Research Journal of Pharmacy and Technology. 2021; 14(6): 2937-2944. DOI: 10.52711/0974- 360X.2021.00515
30.    Vaghela, A., Patel, A.B., Patel, A.I., Vyas, A.J., Patel, N.K. Sample Preparation in Bioanalysis: A Review. International Journal of Scientific and  Technology Research. 2016; 5(5): 6-10.
31.    Patel, A. B., Vaghasiya, E. H., Dudhatra, A. R., Vyas, A. J., Patel, A. I., Patel, N. K., and  Jadav, H. M. Stability indicating photodiode array detector-based estimation of dapagliflozin propanediol monohydrate in API and tablet dosage form by RP-UPLC. Research Journal of Pharmacy and Technology. 2021; 14(9): 4635–4639. https://doi.org/10.52711/0974-360X.2021.00805
32.    Paul, D., Allakonda, L., and Satheeshkumar, N. A validated UHPLC-QTOF-MS method for quantification of metformin and teneligliptin in rat plasma: Application to pharmacokinetic interaction study. Journal of Pharmaceutical and Biomedical Analysis. 2017; 143: 1–8. https://doi.org/10.1016/j.jpba.2017.05.026
33.    BR, J., KV, S., and PP, K. Development and Validation of UV Spectroscopic First Derivative Method for Simultaneous Estimation of Dapagliflozin and Metformin Hydrochloride in Synthetic Mixture. Journal of Bioequivalence Studies. 2015; 4(5): 245-266 https://doi.org/10.15744/2575-551x.1.102
34.    Madana Gopal, N., and  Sridhar C. A validated stability indicating ultra-performance liquid chromatographic method for simultaneous determination of metformin hydrochloride and empagliflozin in bulk drug and tablet dosage form. International Journal of Applied Pharmaceutics. 2017; 9(3): 45–50. https://doi.org/10.22159/ijap.2017v9i3.17441
35.    ICH Harmonised Tripartite Guideline. Validation of Analytical Procedures: Text and Methodology Q2(R1). International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, Geneva, 2005;1-13.


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