Mir Khalid Bashir, Abrol Vidushi, Wani Taha U, Jan Ishrat, Singh Nasseb, Khan Nisar A, Dar Alamgir A, Sabri Sultan Rania Mohammad, Lone Showkat A, Iesa Mohamed A M, Alhag Sadeq K, Al-Shuraym Laila A, Helm Nawal, Al-Farga Ammar
Department of Pharmaceutical Sciences, University of Kashmir, J&K, 190001, India.
School of Medical & Allied Sciences, KR Mangalam University, Gurgaon, Haryana, India.
Heliyon. 2023 Oct 17;9(11):e20876. doi: 10.1016/j.heliyon.2023.e20876. eCollection 2023 Nov.
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 C 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 r = 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.
在此，我们报告了一种新颖、简单、特异、准确且成本低廉的经过验证的反相高效液相色谱（RP-HPLC）方法，用于定量大鼠血浆中第二代磺酰脲类抗糖尿病药物格列本脲（GLB），并将其应用于计算Wistar大鼠的药代动力学参数。所用内标为氟芬那酸。色谱分离在C柱（250 mm×4.6 mm×5μm，安捷伦- Zorbax，SB）上进行，采用等度洗脱，流动相为乙腈：水（1:1；v/v），用0.03%冰醋酸将pH调至4.0，并用光电二极管阵列作为检测器进行检测。在大鼠血浆中绘制的校准曲线在50 - 1200 ng/ml范围内呈线性，r = 0.998。最低定量限为40 ng/ml。该方法有效地应用于Wistar大鼠口服固体分散体制剂后格列本脲的药代动力学研究。文献中有几种方法可用于格列本脲的定量，但这些方法繁琐、灵敏度较低、同时分离度较小且耗时。因此，本方法最适合用于定量Wistar大鼠体内的格列本脲。
