Validated HPLC and stability-indicating densitometric chromatographic methods for simultaneous determination of camylofin dihydrochloride and paracetamol in their binary mixture

摘要

Two accurate, sensitive, precise and selective HPLC and stability-indicating TLC methods were developed for the simultaneous determination of camylofin-2HCl and paracetamol. Forced acid, alkali and oxidative degradation of camylofin-2HCl were tried where complete degradation was achieved using 5 N HCl. HPLC method was developed to determine the mixture of the two drugs using Zorbax NH2 column and a mobile phase of 0.5% triethylamine and pH 3.0 adjusted with 0.1% phosphoric acid and methanol (70:30 v/v) over concentration ranges of 3-90 and 10-95 mu g/mL for camylofin-2HCl and paracetamol, respectively.TLC method was used for the separation of camylofin from its acid degradate and paracetamol using chloroform-methanol-acetone-conc. ammonia (8:2:2:0.1, by volume) as developing system and band scanning at 254 nm over concentration ranges of 5-40 mu g/band for camylofin-2HCl and 0.1-0.5 mu g/band for paracetamol. The validation of two methods was carried out according to ICH guideline. Accuracy ranged between 98.47 and 100.67% for the two methods with acceptable precision RSD% ranging between 0.66 and 1.47%.