Multivariate optimization and validation of an analytical methodology by RP-HPLC for the determination of losartan potassium in capsules

Abstract

This paper describes the optimization and validation of an analytical methodology for the determination of losartan potassium in capsules by HPLC using 2(5-1) fractional factorial and Doehlert designs. This multivariate approach allows a considerable improvement in chromatographic performance using fewer experiments, without additional cost for columns or other equipment. The HPLC method utilized potassium phosphate buffer (pH 6.2; 58 mmol L(-1))-acetonitrile (65:35, v/v) as the mobile phase, pumped at a flow rate of 1.0 mL min(-1). An octylsilane column (100 mm x 4.6mm i.d., 5 microm) maintained at 35 degrees C was used as the stationary phase. UV detection was performed at 254 nm. The method was validated according to the ICH guidelines, showing accuracy, precision (intra-day relative standard deviation (R.S.D.) and inter-day R.S.D values <2.0%), selectivity, robustness and linearity (r=0.9998) over a concentration range from 30 to 70 mg L(-1) of losartan potassium. The limits of detection and quantification were 0.114 and 0.420 mg L(-1), respectively. The validated method may be used to quantify losartan potassium in capsules and to determine the stability of this drug.

Losartan potassium dissolution test for drug release evaluation in pharmaceutical capsules using HPLC and UV spectrophotometry

“…In the HPLC analysis, the chromatographic conditions were based on the previous work, 35 in which a HPLC method for the quantitation of losartan potassium in pharmaceutical capsules was developed and validated. In order to confirm if the chromatographic parameters are in accordance with literature, a system suitability test was carried out by injecting six replicates of a work standard solution of losartan potassium containing 55.5 mg L -1 .…”

Analytical chemistry in Brazil: healthy and growing

“…Recent applications and method validation carried out by Brazilian authors include determination of losartan, 185 nadolol, 186 sotalol hydrochloride 187 and pancuronin bromide 188 by HPLC. GC-MS was employed for the simultaneous determination of amphetamines and ephedrines in urine with an alternative chemical derivatization.…”

Stability-indicating RP-LC method for quantification of fusidic acid in cream

“…Chromatographic methods prioritizing shorter analyses that are economically viable, reduce the quantities of waste to the environment, and are safer for the analyst, are of great importance and have gained prominence (Bonfilio et al, 2009;Lopes, Salgado, 2009;Moreno, Salgado, 2008;Pedroso, Salgado, 2014;Rugani, Salgado, 2014;Silva, Salgado, 2012;Tótoli, Salgado, 2014;Vieira, Salgado, 2011).…”