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Novel Validated Approach for the Simultaneous Determination of Lobeglitazone Sulfate and Glimepiride in Its Pure andCombined Dosage Form Using Tandem Quantification Methods by UV-Vis Spectroscopy

Abstract

Lobeglitazone sulfate and glimepiride are type 2 antidiabetic drugs in which lobeglitazone sulfate functions as an insulin sensitizer and glimepiride lowers blood sugar by causing the pancreas to produce insulin. This research article proposes a novel, simple, accurate, reproducible, and economical tandem method that can be used in the future for small-scale project analyses. Method A (absorption correction), in which the absorption maximum for lobeglitazone sulfate was 350 nm, also showed absorbance at 226 nm, which was found to be the absorption maximum for glimepiride, which shows zero absorbance at 350 nm. The techniques developed exhibited good linearity, ranging from 4 to 10.4 µg/mL for lobeglitazone sulfate and from 8 20.8 µg/mL for glimepiride, with excellent correlation coefficients (R2 = 0.999) for the two drugs. Method B (absorption ratio) explains the absorption ratio by selecting the maximum wavelength of one drug and one isosbestic point where both drugs show the same absorbance. The method developed showed good linearity, ranging from 0.8 to 7.2 µg/mL for lobeglitazone sulfate at 250 nm and 226 nm and from 1.6 to 14.4 µg/mL for glimepiride at 250 nm and 226 nm, with excellent correlation coefficients (R2 = 0.9987 for lobeglitazone sulfate at two wavelengths and R2 = 0.9987 for glimepiride). Both methods exhibited good linearity with excellent correlation coefficients. The intraday and interday accuracy and precision, with a low percentage relative standard deviation, demonstrated better recovery and reproducibility. A sensitivity test was performed by calculating the limit of detection and the limit of quantification.

About the Authors

G. Megha
Kerala University of Health Sciences, Grace College of Pharmacy, Department of Pharmaceutical Analysis
India

Palakkad, Kerala



Sheeja Velayudhan Kutty
Kerala University of Health Sciences, Grace College of Pharmacy, Department of Pharmaceutical Analysis
India

Palakkad, Kerala



Y. Haribabu
Kerala University of Health Sciences, Grace College of Pharmacy, Department of Pharmaceutical Analysis
India

Palakkad, Kerala



Gokul J. Siddharth
Kerala University of Health Sciences, Grace College of Pharmacy, Department of Pharmaceutical Analysis
India

Palakkad, Kerala



C. P. Anupama
Kerala University of Health Sciences, Grace College of Pharmacy, Department of Pharmaceutical Analysis
India

Palakkad, Kerala



Jikhila Machado
Kerala University of Health Sciences, Grace College of Pharmacy, Department of Pharmaceutical Analysis
India

Palakkad, Kerala



V. Divya
Kerala University of Health Sciences, Grace College of Pharmacy, Department of Pharmaceutical Analysis
India

Palakkad, Kerala



References

1. https://www.medicalnewstoday.com/articles/317477#:~:text=Type%202%20diabetes%20can%20lead,can%20help%20prevent%20diabetes%20complications.

2. https://www.larenon.com/wp-content/uploads/2023/03/LOBULA-0.5-LBL.pdf.

3. M. Balamurugan, S. Sarumathy, R. Robinson, Cureus, 15, No. 12 (2023), doi: 10.7759/cureus.50085.

4. https://pubchem.ncbi.nlm.nih.gov/compound/Lobeglitazone-sulfate.

5. Ana Maria Pelin, Cristian Catalin Gavat, Gabriela Balan1, Costinela Valerica, Georgescu. Rev. Chim., 68, No. 2, 378–383 (2017).

6. A. H. Beckett, J. B. Stenlake, Practical pharmaceutical chemistry, fourth edition-part two, 286–288 (2007).

7. Y. R. Sharma, Elementary Organic Spectroscopy, Fourth Revised and Multicolor Edition, 23–26 (2007).

8. S. Murugan, T. Vetrichelvan, RJPT, 12, No. 10, 4795–4798 (2019).

9. https://www.ema.europa.eu/en/documents/scientific-guideline/ich-guideline-q2r1-validation-analyticalprocedures-text-methodology-step-5-first-version_en.pdf.

10. Ashim Kumar Sen, Tantul Sarkar, Dhanya B. Sen, Rajesh A. Maheshwari, Aarti S. Zanwar, Rajesh L. Dumpala, SSC Plus (2024), https://doi.org/10.1002/sscp.202400059.

11. Kanan J. Patel, PriyankaYadav, IJPRA J., 9, No. 2, 2168–2185 (2024).

12. Dhara Patel, Jeel Dobariya, Prasanna Pradhana, Grishma Patela, Dhananjay Meshrama, Drug Anal. Res., 8, No. 1, 62–69 (2024).


Review

For citations:


Megha G., Kutty Sh.V., Haribabu Y., Siddharth G.J., Anupama C.P., Machado J., Divya V. Novel Validated Approach for the Simultaneous Determination of Lobeglitazone Sulfate and Glimepiride in Its Pure andCombined Dosage Form Using Tandem Quantification Methods by UV-Vis Spectroscopy. Zhurnal Prikladnoii Spektroskopii. 2025;92(2):267.

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ISSN 0514-7506 (Print)