Abstract
A rapid, specific, sensitive, and precise reverse-phase UPLC method developed for the quantitative determination of an atypical antipsychotic drug Iloperidone and its eight potential impurities in drug substances and drug products is described in this report. Chromatographic separation was achieved on a Waters Acquity UPLC® HSS C18 (2.1 mm × 100 mm, 1.8 micron) column thermostated at 35°C with a short runtime of 10 min. Quantification is achieved with photodiode array detection at 225 nm over the concentration range of 0.03 - 0.15 μg/mL. Forced degradation study was carried out under acidic, alkaline, oxidative, photolytic and thermal conditions to demonstrate the stability-indicating capability of the developed UPLC method. Comparison of system performance with conventional high-performance liquid chromatography is made with respect to analysis time, efficiency, and sensitivity. The method is validated according to the ICH guidelines and is applied successfully for the determination of Iloperidone in tablets.
Highlights
Ultra Performance Liquid Chromatography (UPLC) has become promising high speed chromatographic separation technique in the field of pharmaceutical industry
UPLC offers substantial improvements on chromatographic resolution, speed and sensitivity analysis compared to conventional HPLC separation techniques
The present study was aimed to develop a chromatographic system capable of eluting and resolving Iloperidone, its process related and degradation related impurities (Imp-1 to Imp-8) in short run time which complies with the general requirement of system suitability
Summary
Ultra Performance Liquid Chromatography (UPLC) has become promising high speed chromatographic separation technique in the field of pharmaceutical industry. UPLC offers substantial improvements on chromatographic resolution, speed and sensitivity analysis compared to conventional HPLC separation techniques. High efficiency and less run time are the two major advantages of this technology. It utilizes sub-2 mm particles for the stationary phase and saves time and reduces solvent consumption. These particles operate at elevated mobile phase linear velocities to affect dramatic increase in the efficiency [1] [2]. This technology has been applied to the method development, validation, and assay determination of Iloperidone bulk drug
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