Assay of Empagliflozin in Empagliflozin Tablets by HPLC

Dr. Parag Das (Ph.D.) ^1*, Mr. Updesh Singh ², Mr. Animesh Maity (M.Sc.) ³, Mr. Amrit Kumar Rath ⁴, Prof. (Dr.) Sruti Ranjan Mishra ⁵, Mrs. Amrita Nayak ⁶, Mrs. Manashi Das ⁷

^1*Vice President – Technical, Oman Pharmaceutical Products Co LLC, Sultanate of Oman.

²Sr. Officer, Analytical Development Labs, Oman Pharmaceutical Products Co LLC, Sultanate of Oman.

³Sr. Manager, Analytical Development Labs, Oman Pharmaceutical Products Co LLC, Sultanate of Oman.

⁴Associate Professor, Danteswari College of Pharmacy, Borpadar, Raipur Road, Jagdalpur, Chhattisgarh, Pin: 494221, India.

⁵Professor, Danteswari College of Pharmacy, Borpadar, Raipur Road, Jagdalpur, Chhattisgarh, Pin: 494221, India.

⁶Associate Professor, Danteswari College of Pharmacy, Borpadar, Raipur Road, Jagdalpur, Chhattisgarh, Pin: 494221, India.

⁷Freelance Pharma Professional, Pune, India.

*Corresponding Author: Dr. Parag Das (Ph.D.), Vice President – Technical, Oman Pharmaceutical Products Co LLC, Sultanate of Oman.

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ABSTRACT

Background: Empagliflozin is a member of the sodium-glucose co-transporter 2 (SGLT2) inhibitor class, which helps lower blood glucose levels by promoting the excretion of glucose through urine. It is indicated for type 2 diabetes and is not suitable for managing type 1 diabetes, where insulin production is absent. Persistent high blood sugar in diabetes may lead to serious complications, including cardiovascular disease, kidney damage, neuropathy, and vision problems. The use of empagliflozin, combined with lifestyle modifications such as diet, exercise, and smoking cessation, along with regular blood glucose monitoring, can aid in glycemic control and reduce the risk of diabetes-related complications. Each 10 mg tablet contains 10 mg of empagliflozin, and each 25 mg tablet contains 25 mg of the drug. Recent dosage forms include orally disintegrating tablets (ODTs) and films to improve patient compliance.

Aim: The study aims to develop and validate a simple, rapid, and cost-effective HPLC-UV method for the simultaneous estimation of empagliflozin in tablet formulations. The method involves sample dilution with a diluent and chromatographic separation using a Waters e2695 HPLC system with a Waters Symmetry C8 column (250 mm × 4.6 mm, 5 µm). The mobile phase consists of a 50:50 v/v mixture of buffer and acetonitrile, with a column flow rate of 1.0 mL/min, column temperature set at 40°C, and autosampler temperature at 20°C. Empagliflozin eluted at approximately 8.0 minutes.

Results and Discussion: The developed method was validated according to the ICH guidelines and values of accuracy; method precision and other statistical analysis were found to be in good accordance with the specified acceptance criteria.

Conclusion: Validation of the method followed ICH guidelines. Accuracy, precision, linearity, and other statistical parameters were within the acceptable criteria, confirming the reliability of the method.

Keywords: Empagliflozin, HPLC-UV, PDA, Validation.

How to cite this article: Das P, Singh U, Maity A, Rath AK, Mishra SR, Nayak A, Das M. Assay of empagliflozin in empagliflozin tablets by HPLC. Int J Drug Deliv Technol. 2026;16(6s): 101-105; DOI: 10.25258/ijddt.16.6s.12

Source of support: Nil.

Conflict of interest: None