Development and Validation of a Stability-Indicating Reversed Phase Hplc Method for the Quality Control of Zolpidem in Bulk and Tablet Dosage Forms Publisher



Yaripour S¹ ; Rashid SN¹ ; Alibakhshi H¹ ; Mohammadi A^{1, 2, 3}
Source: Journal of Analytical Chemistry Published:2015

Abstract

An isocratic stability-indicating reversed phase liquid chromatography (RP-HPLC) method for quantitative determination of Zolpidem in the presence of its stressed degradation products in bulk and commercial tablets was developed and validated. Forced degradation studies were carried out on bulk samples and tablet dosage forms of Zolpidem using acid, base, H2O2, heat, and UV light as described by International Conference on Harmonization (ICH) for stress conditions to demonstrate the stability indicating power of the method. A Perfectsil® Target ODS column (3–5 μm, 125 × 4 mm) was used for chromatographic separation. The mobile phase consisted of methanol-50 mM ammonium acetate buffer (pH 3.7, 40: 60, v/v). The flow rate was 0.7 mL/min and UV detection was optimized at 254 nm. The present method linearity for Zolpidem was investigated in the range of 1–20 μg/mL (r = 0.9998). The limits of detection (LOD) and quantification (LOQ) were 400 and 1000 ng/mL respectively. The method selectivity was evaluated by peak purity test using a diode array detector. There was no interference with detection of Zolpidem and its stressed degradation products. © 2015, Pleiades Publishing, Ltd.