Validation and development of RP-HPLC method for quantification of glibenclamide in rat plasma and its application to pharmacokinetic studies in wistar rats

Khalid Bashir Mir; Vidushi Abrol; Taha U Wani; Ishrat Jan; Nasseb Singh; Nisar A Khan; Alamgir A Dar; Rania Mohammad Sabri Sultan; Showkat A Lone; Mohamed A M Iesa; Sadeq K Alhag; Laila A Al-Shuraym; Nawal Helm; Ammar Al-Farga

doi:10.1016/j.heliyon.2023.e20876

Validation and development of RP-HPLC method for quantification of glibenclamide in rat plasma and its application to pharmacokinetic studies in wistar rats

Heliyon. 2023 Oct 17;9(11):e20876. doi: 10.1016/j.heliyon.2023.e20876. eCollection 2023 Nov.

Authors

Khalid Bashir Mir^{1

2}, Vidushi Abrol³, Taha U Wani¹, Ishrat Jan⁴, Nasseb Singh⁵, Nisar A Khan¹, Alamgir A Dar⁴, Rania Mohammad Sabri Sultan⁶, Showkat A Lone⁷, Mohamed A M Iesa⁸, Sadeq K Alhag⁹, Laila A Al-Shuraym¹⁰, Nawal Helm¹¹, Ammar Al-Farga¹²

Affiliations

¹ Department of Pharmaceutical Sciences, University of Kashmir, J&K, 190001, India.
² School of Medical & Allied Sciences, KR Mangalam University, Gurgaon, Haryana, India.
³ Fermentation & Microbial Biotechnology Division, CSIR-Indian Institute of Integrative Medicine, Canal Road, Jammu Tawi, J&K, 180001, India.
⁴ Research Centre for Residue and Quality Analysis, Sher-e-Kashmir University of Agricultural Sciences & Technologyof Kashmir, Shalimar Campus, Srinagar, J&K, 190025, India.
⁵ Synthetic Organic Chemistry Laboratory, Faculty of Sciences, Shri Mata Vaishno Devi University, Katra, 182320, India.
⁶ King Abdul-Aziz University Faculty of Science, Department of Biological Sciences, Saudi Arabia.
⁷ Department of Basic Sciences, College of Science and Theoretical Studies, Saudi Electronic University, Jeddah-M, Riyadh, 11673, Saudi Arabia.
⁸ Department of Physiology, Al Qunfudah Medical College, Umm Al Qura University, Mecca, Saudi Arabia.
⁹ Biology Department, College of Science and Arts, King Khalid University, Muhayl Asser, 61913, Saudi Arabia.
¹⁰ Biology Department, Faculty of Science, Princess Nourah Bint Abdulrahman University, Riyadh, Saudi Arabia.
¹¹ Biochemistry Departments, College of Science, Unversity of Jeddah, Jeddah, 23218, Saudi Arabia.
¹² Department of Biochemistry, College of Science, University of Jeddah, Jeddah, 23218, Saudi Arabia.

Abstract

Herein, we report a novel, simple, specific, accurate and cost-friendly validated reverse phase-high performance liquid chromatographic (RP-HPLC) method for the quantification of second generation sulphonylurea based antidiabetic drug, glibenclamide (GLB) in rat plasma and its application to calculate pharmacokinetic parameters in wistar rats. The internal standard used was flufenamic acid. The chromatographic separation was conducted on C₁₈ column (250 mm × 4.6 mm x 5 μm, Agilent-Zorbax, SB) using isocratic elution with mobile phase containing Acetonitrile: Water (1:1; v/v) pH adjusted to 4.0 with 0.03 % glacial acetic acid and detected by photo-diode array as detector. Calibration curves made in the rat plasma were linear in the range of 50-1200 ng/ml with r² = 0.998. The LLOQ was 40 ng/ml. This method was effectively applied for pharmacokinetic studies of Glibenclamide following administration through oral route as solid dispersion formulation to Wistar rats. Several methods are available in the literature which can be employed for the quantification of Glibenclamide but such methods are tedious, provide lower sensitivity, less simultaneous resolution and are time-consuming. Therefore the present methods suits best for the quantification of Glibenclamide from Wistar rats.

Keywords: Glibenclamide; Method validation; Pharmacokinetics; Plasma; RP-HPLC; Wistar rats.