HPLC-PDA determination of losartan potassium and hydrochlorothiazide using design of experiments

الملخص EN

A simple, rapid, precise, accurate, sensitive and stability indicating high performance liquid chromatographic method has been developed for simultaneous determination of losartan potassium and hydrochlorothiazide in pharmaceutical formulations.

Method development and optimization was carried out using ‘Design of Experiments’ (DoE).

Optimized mobile phase (v/v/v) was water (containing 0.25 ml/L triethylamine), methanol and acetonitrile (60:38:30, pH adjusted to 2.7±0.1).

Chromatographic separation was achieved on Hypersil®-Gold C18 (150 x 4.6 mm, 5 μm, Thermo Fisher Scientific, USA), column at 25 ± 2°C.

The mobile phase flow rate was 1.0 m/min.

The analysis was carried out at 271 nm using 10 μl samples.

The method was validated as per the International Conference on Harmonization (ICH) guidelines.

This method had a chromatographic run time of 10.0 min and a linear calibration curves ranged from 2.0 to 48.0 μg/mL for losartan potassium, and 0.5–12.0 μg/mL for hydrochlorothiazide.

The limits of detection for hydrochlorothiazide and losartan potassium were 0.013 and 0.138 μg/ml while the limits of quantitations were 0.039 and 0.418 μg/ml, respectively.

Stability studies indicate that the degradation of drugs was higher during oxidative stress than other stress.

No photolytic degradation was observed.