Una din cele mai uzuale si accesibile metode de analiza ramane a fi Spectrofotometria UV, care poseda un grad de sensibilitate si informativitate inalt. Metoda este universala, poate fi combinata cu alte metode, poseda eroarea minima, precum si o eficienta economica acceptabila. Scopul lucrarii. Elaborarea si validarea metodei spectrofotometrice de dozare a clorhidratului de ciprofloxacina (CIP) si nitratului de econazol (EC) in picaturi auriculare combinate. Materiale si metode. Spectrofotometru UV-VIS Agilent 8453, probe standard de CIP si EC, picaturi auriculare (serie experimentala de laborator), metanol, solutie HCl 0,1 M. Validarea metodei spectrofotometrice s-a petrecut in conformitate cu prevederile ghidului ICH. Rezultate. Linearitatea s-a cercetat pe domeniile de concentratie 5-30 ¬μg/ml pentru CIP si 10-80 ¬μg/ml pentru EC. Valorile r2 au constituit 0,9945 pentru CIP si respectiv 0,9929 pentru EC. Limita de detectie a constituit 0,384 ¬μg/ml pentru CIP si 1,263 ¬μg/ml pentru EC; limitele de cuantificare au fost 1,165 si 3,827 ¬μg/ml pentru CIP si EC corespunzator. Rezultatele obtinute au demonstrat ca metoda spectrofotometrica elaborata este exacta (in limitele 80-120% din valoarea nominala a continutului de principii active in preparat), precisa (prin evaluarea repetabilitatii si preciziei intermediare), robusta (prin variatia lungimilor de unda in maximele de absorbtie) si specifica, valorile deviatiei relative standard pentru acesti parametri nu au depasit 1,0%. Concluzii. Metoda spectrofotometrica elaborata prezinta linearitate, exactitate, precizie, robustete si specificitate, poate fi inclusa in specificatia de calitate pentru dozarea CIP si EC in picaturile auriculare combinate. Cuvinte cheie. Dozare, spectrofotometrie, picaturi auriculare combinate, ciprofloxacina, econazol, validare.

One of the most common and accesible methods of analysis remains UV Spectrophotometry, which has a high degree of sensitivity and informativeness. The method is universal, can be combined with other methods, has minimal error and acceptable economic efficiency. The purpose. Development and validation of the spectrophotometric method for the determination of ciprofloxacin hydrochloride (CIP) and econazole nitrate (EC) in combined ear drops. Materials and methods. Agilent 8453 UV-VIS spectrophotometer, standard CIP and EC samples, ear drops (experimental laboratory series), methanol, 0,1M HCl solution. The validation of the spectrophotometric method took place in accordance with the provisions of the ICH guide. Results. Linearity was investigated on concentration ranges 5-30 μg/ml for CIP and 10-80 μg/ml for EC. The values of r2 were 0,9945 for CIP and 0,9929 for EC, respectively. The limit of detection was 0,384 μg/ml for CIP and 1,263 μg/ml for EC; the quantification limits were 1,165 (CIP) and 3,827(EC) μg/ml. The obtained results showed that the developed spectrophotometric method is accurate (within the limits of 80-120% of the nominal value of the content of active principles in the preparation), accurate (by evaluating of the repeatability and intermediate accuracy), robust (by variation of the wavelengths in the absorption maxima) and specific, the values of the standard deviation for these parameters ˂1,0%. Conclusions. The developed spectrophotometric method presents linearity, accuracy, precision, robustness and specificity, it can be included in the quality specification for CIP and EC dosing in combined ear drops.