Author(s):
Manojkumar K. Munde, Nilesh S. Kulkarni, Rahul H. Khiste, Dhanya B. Sen
Email(s):
manojpcist@gmail.com
DOI:
10.5958/0974-360X.2020.00228.0 
Address:
Manojkumar K. Munde 1,2*, Nilesh S. Kulkarni2, Rahul H. Khiste3, Dhanya B. Sen1
1Department of Pharmacy, Sumandeep Vidyapeeth Deemed to be University, Piparia, Vadodara-391760, Gujarat, India.
2PES Modern College of Pharmacy (for Ladies), Moshi, Maharashtra, Pune, India. Affiliated to Savitribai Phule Pune University, Pune.
3Marathwada Mitra Mandal’s College of Pharmacy, Thergaon, Pune-411033, Maharashtra. India. Affiliated to Savitribai Phule Pune University, Pune.
*Corresponding Author
Published In:
Volume - 13,
Issue - 3,
Year - 2020
ABSTRACT:
Four new UV spectrophotometric methods namely simultaneous equation, absorbance ratio, area under curve and first derivative (zero crossing) spectroscopic methods were developed and validated for simultaneous estimation Empagliflozin and Metformin hydrochloride in bulk and tablet formulation. In simultaneous equation method, absorbance was measured at 224 and 232 nm for both the drugs. Empagliflozin and Metformin hydrochloride was estimated using 224 and 232 nm in absorbance ratio method. In Area under curve method both drugs were estimated at 224 and 232 nm respectively. First derivative (zero crossing) method was based on the transformation of UV spectra in to first derivative spectra followed by measurement of first derivative signal at 224 and 232 nm for Empagliflozin and Metformin hydrochloride, respectively using 2 nm as wavelength interval (??) and 1 as scaling factor. Methods were found to be simple, fast, highly sensitive, cost effective and hence can be useful for simultaneous estimation of Empagliflozin and Metformin hydrochloride in commercial tablet formulation for routine quality control analysis.
Cite this article:
Manojkumar K. Munde, Nilesh S. Kulkarni, Rahul H. Khiste, Dhanya B. Sen. Development and Validation of Novel Analytical Method for Empagliflozin and Metformin Hydrochloride in Bulk and Pharmaceutical Dosage Form by Four Different Simultaneous Estimation Approaches using UV Spectroscopy. Research J. Pharm. and Tech 2020; 13(3):1236-1242. doi: 10.5958/0974-360X.2020.00228.0
Cite(Electronic):
Manojkumar K. Munde, Nilesh S. Kulkarni, Rahul H. Khiste, Dhanya B. Sen. Development and Validation of Novel Analytical Method for Empagliflozin and Metformin Hydrochloride in Bulk and Pharmaceutical Dosage Form by Four Different Simultaneous Estimation Approaches using UV Spectroscopy. Research J. Pharm. and Tech 2020; 13(3):1236-1242. doi: 10.5958/0974-360X.2020.00228.0 Available on: https://rjptonline.org/AbstractView.aspx?PID=2020-13-3-33
REFERENCES:
1. Inzucchi SE, Zinman B, Fitchett D, Wanner C,
Schumacher M. How does empagliflozin reduce cardiovascular mortality? Insights
from a mediation analysis of the Empa-reg outcome trial. Diabetes Care 2018;41(2):356-63.
2. Hinnen D. Short commentary on empagliflozin and its
potential clinical impact. Ther. Adv. Endocrinol. Metabol. 2015; 6(2):68-81.
3.
Chawla G,
Chaudhary KK. A complete review of empagliflozin: Most specific and potent
SGLT2 inhibitor used for the treatment of type 2 diabetes mellitus. Diabetes and
Metabolic Syndrome: Clinical Research and Reviews 2019; 13: 2001-8.
4.
Raheli C D, Javor
E, Lucijani C T, Skelin M. Effects of antidiabetic drugs on the incidence of
macrovascular complications and mortality in type 2 diabetes mellitus: a new
perspective on sodiumeglucose co-transporter 2 inhibitors. Ann Med 2016; 20:
1-2.
5.
Joshua JN.
Empagliflozin: a new sodium-glucose co-transporter 2 (SGLT2) inhibitor for the
treatment of type 2 diabetes. Drugs in Context 2014; 3: 3-17.
6.
Kara ML,
Elizabeth S, Allen L, Julie Y, Jonathan F. Metformin as Treatment for
Overweight and Obese Adults: A Systematic Review. Ann Fam Med 2005; 3(5):
457-61.
7. Benoit V, Bruno G, Nieves SG, Jocelyne L. Cellular and
molecular mechanisms of metformin: an overview. Clin Sci (Lond) 2012; 122(6):
253–70.
8. Ruisheng S. Mechanism of Metformin: A Tale of Two
Sites. Diabetes Care. 2016; 39(2): 187-89.
9. Beckett AH, Stenlake JB. Instrumental methods in the
development and use of medicines. In: practical pharmaceutical chemistry
(Part-2), 4th edition. New Delhi, CBS Publishers and Distributors, 2005;
275-99.
10. Sen AK, Sen DB, Maheshwari RA, Balaraman R, Seth AK.
Simultaneous estimation of Aliskiren hemifumarate and Hydrochlorothiazide in
combined Tablet Formulation by Simultaneous equation, Absorbance ratio and
First derivative Spectroscopic Methods. J App Pharm Sci 2016; 6 (07): 164-70.
11. International Conference on Harmonization (ICH).
Validation of Analytical Procedures: Text and Methodology Q2(R1). Geneva; 2005.