Abstract:
Empagliflozin, a selective sodium-glucose co-transporter 2 (SGLT2) inhibitor, is
widely used for the management of type 2 diabetes mellitus (T2DM). Ensuring
the quality and consistency of empagliflozin-containing pharmaceutical products
requires validated analytical methods that are simple, accurate, and cost-effective.
This study aimed to develop and validate a UV spectrophotometric method for
the quantitative estimation of empagliflozin in bulk drug and tablet formulations,
following ICH Q2(R1) guidelines. A UV spectrophotometric method was developed
using a 50:50 methanol-deionised water solvent system. The λmax (223 nm)
was identified from the absorption spectrum, and calibration curves were prepared
within the 2–20 μg/mL range. Validation parameters—including linearity, specificity,
accuracy, precision, limits of detection and quantification (LOD/LOQ), and
solution stability—were evaluated per ICH Q2(R1). Commercial empagliflozin 10
mg tablets were assayed using both the developed UV method (200–400 nm range)
and a validated HPLC method to confirm method accuracy. Empagliflozin exhibited
optimal solubility and spectral stability in the selected solvent system, with
a prominent λmax at 223 nm. Calibration data demonstrated excellent linearity
(R = 0.9994). Method validation confirmed excellent specificity, with no interference
from excipients. Accuracy studies demonstrated recovery values ranging
from 97.1% to 99.8%, while intra-day and inter-day precision yielded %RSD values
of 0.57% and 0.53%, respectively. The LOD and LOQ were 0.34 μg/mL
and 1.03 μg/mL, respectively. Analytical solutions remained stable for up to 24
hours at room temperature with less than 1% change in absorbance. API content
obtained using UV spectrophotometry (97.8%) closely matched that obtained
by HPLC (98.2%), supporting the reliability of the developed method. Overall,
the developed UV spectrophotometric method is simple, rapid, environmentally
friendly, and cost-effective, meeting all regulatory validation requirements. It is
suitable for routine quality control of empagliflozin formulations and provides an
accessible alternative to chromatographic techniques, particularly in laboratories
with limited resources.
