Author(s):
Tejaswi Gilakamsetti, Poojitha Nalluri, Ramya Kuber Banoth
Email(s):
ramyakuber.spmvv@gmail.com
DOI:
10.52711/0974-360X.2024.00733 
Address:
Tejaswi Gilakamsetti1, Poojitha Nalluri2, Ramya Kuber Banoth3*
1Department of Pharmaceutical Analysis, Institute of Pharmaceutical Technology, Sri Padmavati Mahila Visvavidyalayam (Women's University), Tirupati, 517502, Andhra Pradesh, India.
2Student of Institute of Pharmaceutical Technology, Sri Padmavati Mahila Visvavidyalayam (Women's University), Tirupati, 517502, Andhra Pradesh, India.
3Department of Pharmacognosy, Institute of Pharmaceutical Technology, Sri Padmavati Mahila Visvavidyalayam (Women's University), Tirupati, 517502, Andhra Pradesh, India
*Corresponding Author
Published In:
Volume - 17,
Issue - 10,
Year - 2024
ABSTRACT:
In this research, a simple yet highly accurate, rapid, precise stability-indicating RP-HPLC method has been developed to quantify the concentration of Bexagliflozin in the pharmaceutical dosage form. The chromatographic elution has been performed on a reverse phase Discovery C18 column (150mm x 4.6mm, I.D. 5µm) using a mobile phase comprised of 0.01N Na2HPO4: CH2OH (55:45 v/v), adjusted to a pH of 4.0 using 0.1% orthophosphoric acid. The flow rate was 0.9 mL min-1, and analysis was performed by a photodiode array detector at a wavelength of 220nm. The retention time of bexagliflozin was accurately measured to be 2.724 min. The drug demonstrated linearity across the 5-30µg mL-1 range of concentrations (R2 0.999). The results showed that the LOD and LOQ had been 0.004µg mL-1 and 0.011µg mL-1, respectively. Forced degradation was carried out by following the guidelines of the ICH Q1A (R2), and the developed approach underwent validation in compliance with the ICH requirements. A novel stability-indicating RP-HPLC procedure has been developed for the accurate quantification of bexagliflozin. The suggested approach was effectively utilized to routinely analyze bexagliflozin in both its pure form and pharmaceutical formulations.
Cite this article:
Tejaswi Gilakamsetti, Poojitha Nalluri, Ramya Kuber Banoth. Development and Validation of a Novel RP-HPLC Method for Estimation of Bexagliflozin in Pure and Pharmaceutical Formulation. Research Journal of Pharmacy and Technology. 2024; 17(10):4758-4. doi: 10.52711/0974-360X.2024.00733
Cite(Electronic):
Tejaswi Gilakamsetti, Poojitha Nalluri, Ramya Kuber Banoth. Development and Validation of a Novel RP-HPLC Method for Estimation of Bexagliflozin in Pure and Pharmaceutical Formulation. Research Journal of Pharmacy and Technology. 2024; 17(10):4758-4. doi: 10.52711/0974-360X.2024.00733 Available on: https://www.rjptonline.org/AbstractView.aspx?PID=2024-17-10-18
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