Development and Validation of Content Uniformity Analytical Procedure of Glipizide Extended Release Tablet

Glipizide is an oral anti-diabetic drug which belongs to the class of second-generation sulfonyl-ureas. The matrices of an extended release (ER) dosage form often bring some problems in the analytical work, so it needs suitable procedure for extraction and separation. In this experiment, the glipizide ERs were prepared for a quantitative analysis by solid phase extraction (SPE) using HLB sorbent and dissolved in the mobile phase. Next, the sample preparations were analyzed with a Reversed Phase High-Performance Liquid Chromatography (RP-HPLC). The good separation was achieved on an HPLC YMC Triart C18 (150 x 4.6 mm, ID S-5 µm 12nm) column. The 0.1M buffer sodium dihydrogen phosphate mono base pH 6.00 ± 0.05 - methanol in the ratio 55:45 was used as the mobile phase, with flow rate of 1.0 mL/min, and column temperature was maintained at 30ºC. The eluted compound was monitored at a wavelength of 225 nm using an UV detector, within a run time of 23 min. Analytical procedure development yielded a good linearity at a range concentration 0.01 – 0.07 mg/mL with its calibration curve: y = 58985.35x + 13.88 and the correlation coefficient of r = 0.9995. The limit of detection (LOD) was determined as 0.0025 mg/mL, meanwhile the limit of quantitation (LOQ) was 0.0075 mg/mL. The % RSD the inter-day precision was obtained 0.90%, 1.40% and 0.86%, while the % RSD the intra-day precision was obtained 1.23%. The mean recovery of glipizide placebo spike was 100.68%. It was concluded that the procedure is valid and can be applied for determination content uniformity of glipizide in the ER tablet dosage forms.