Development and validation of a stability-indicating reversed phase HPLC method for the quality control of Zolpidem in bulk and tablet dosage forms

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 com mercial tablets was developed and validated. Forced degradation studies were carried out on bulk samples and tablet dosage forms of Zolpidem using acid, base, H 2 O 2 , 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 separa tion. 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 Zolp idem was investigated in the range of 1-20 µg/mL (r = 0.9998). The limits of detection (LOD) and quantifi cation (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 degrada tion products.

Zolpidem-Induced Narcolepsy, Faint, Seizure or Coma? A Case Report

“…• As observed in this case and based on the clinical evidences [20], ZLP has a very rapid onset of action. It is highly suggested to administer and use ZLP just before bedtime.…”

Quantitation of zolpidem in biological fluids by electro-driven microextraction combined with HPLC-UV analysis

“…HPLC analysis was performed using a previously reported method (Yaripour et al, 2015[ 46 ]) following partial modification. The modular HPLC system consisted of a Knauer HPLC Pump K-1001, a UV Detector K-2600, a Knauer injection system and a Knauer solvent degasser (Berlin, Germany).…”

Electrooxidation of Zolpidem and its Voltammetric Quantification in Standard and Pharmaceutical Formulation using Pencil Graphite Electrode

“…These methods are mainly based on gas chromatography (GC) [5], spectrophotometry [6][7][8], potentiometry [9], radioimmunoassay [10], high-performance liquid chromatography (HPLC) [11][12][13][14]. Although all these methods display good precision and accuracy, most of them are tedious, time-consuming and have required several preparatory steps prior to testing and skilled practitioner.…”