Vipin K. Sharma, B. Mazumdar

Characterization of gliclazide release from isabgol husk hydrogel beads by validated HPLC method
2014-02-17

Abstract: Isabgol husk, a medicinally important natural polysaccharide was applied for fabrication of hydrogel
beads by ionic gelation method to incorporate gliclazide. Different strengths of Isabgol husk and sodium alginate were utilized for assessing the process variables on formulation performance. Aqueous solution of calcium chloride in 2, 5 and 8% w/v strength was used as cross-linker for polymeric blends of Isabgol husk and sodium alginate. The formulations were characterized for various parameters such as particle size, swelling index, entrapment efficiency, in vitro release, and release kinetics. The quantification of gliclazide throughout the study was performed by HPLC method which was validated according to ICH guidelines for system suitability, linearity, accuracy, sensitivity, precession, robustness, and ruggedness. The surface morphology of beads was observed by scanning electron microscopy. The formed beads were brown, free flowing, spherical, and irregular in structure. The size in different formulations varied from 752.83 ± 0.630 to 838.62 ± 0.741 μm. The beads remained for 2ñ3 h in alkaline phosphate buffer (pH 7.4), after that they showed disintegration. The formulations released up to 95% of loaded gliclazide in phosphate buffer (pH 7.4) within 8 h. No significant
difference was observed in parameters studied such as particle size, entrapment efficiency and swelling index
for hydrogel beads during accelerated stability study (p > 0.05). The regression equation developed by HPLC
method was linear (r2 > 0.9990) over the range 2.5 to 10 μg/mL. The limit of detection (LOD) and limit of quantification (LOQ) were 0.037619 μg/mL and 0.113997 μg/mL, respectively. The observed values for number of theoretical plates (N ≥ 2000), tailing factor (T ≤ 2), asymmetry factor (AF ≤ 1), and relative standard deviation (RSD ≤ 1%) of applied method showed the reliability for gliclazide estimation in Isabgol husk hydrogel beads.

Keywords: validation, Isabgol husk, cross-linking, in vitro release