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Original Article

J App Pharm Sci. 2022; 12(10): 141-147


Spectrophotometric analysis of empagliflozin tablets as SGLT2 inhibitors in pharmaceutical samples

Wael Abu Dayyih, Mohammad Hailat, Tayel A. Al Hujran, Mousa Magharbeh, Zainab Zakaraya, Lina Al Tamimi, Aseel M. Aburumman, Hamza Abumansour, Riad Awad.




Abstract

Azo dyes account for 70% of dye chemistry, and their importance may grow in the future. Empagliflozin is a sodium-glucose co-transporter-2 (SGLT2) inhibitor. SGLT2 transporters are primarily responsible for glucose reabsorption in the kidney. In 2014, empagliflozin was approved for medical use in the United States and the European Union. With over 4 million prescriptions in 2019, it was the 146th most commonly prescribed medication in the United States in 2019. The spectrophotometric determination of empagliflozin is described using coupling agents such as 3-chloro-4- nitroaniline or sulfanilamide. These methods are straightforward and are based on the reaction of empagliflozin with diazotized products of 3-chloro-4-nitroaniline or sulfanilamide to produce colored azo dyes with absorption maxima at 470 and 480 nm. Empagliflozin was linear from 1.2 to 26.6 μgml−1 or 0.8 to 20.4 μgml−1 when combined with diazotized 3-chloro-4-nitroaniline or sulfanilamide, respectively. Empagliflozin’s molar absorptivity and Sandell’s sensitivity to 3-chloro-4-nitroaniline or sulfanilamide azo dyes were 3.179 × 104 l mol−1cm−1 or 4.367 × 104 l mol−1cm−1 and 1.149 × 10−2 μgcm−2 or 8.368 × 10−3 μgcm−2, respectively. The formed colored azo dyes are stable for more than 12 hours. The optimal reaction conditions and other analytical parameters are assessed. Foreign organic compound interference has been studied. The method has been successfully used to determine empagliflozin in pharmaceutical samples.

Key words: Spectrophotometry, Diazotization, Empagliflozin, 3-Chloro 4-nitro aniline, Sulfanilamide






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