Development and validation of an UV derivative spectrophotometric determination of Losartan potassium in tablets

Abstract

Development and validation of an analytical UV derivative spectrophotometric method to quantify Losartan potassium used as a single active principle in pharmaceutical forms were done. Pharmacopeias have not yet provided an official method for its quantification. A study was carried out of all the parameters established by USP XXIV to validate an analytical method for a solid pharmaceutical form, i.e. linearity, range, accuracy, precision and specificity. All these parameters were found in accordance with the acceptance criteria of Comité de Guı́as Oficiales de Validación de la Dirección General de Control de Insumos para la Salud de México. Based on the spectrophotometric characteristics of Losartan potassium, a signal at 234 nm of the first derivative spectrum (1D 234) was found adequate for quantification. The linearity between signal 1D 234 and concentration of Losartan potassium in the range of 4.00–6.00 mg l −1 in aqueous solutions presents a square correlation coefficient (r 2) of 0.9938. The mean recovery percentage was 100.7±1.1% and the precision expressed as relative standard deviation (R.S.D.) 0.88%. In addition, the proposed method is simple, easy to apply, low-cost, does not use polluting reagents and requires relatively inexpensive instruments. Then, it is a good alternative to existing methods for determining Losartan potassium in tablets provided that the pharmaceutical dosage form does not contain hydrochlorothiazide as second drug.