Validated simultaneous TLC-spectrodensitometric method for determination of policresulen and cinchocain hydrochloride in combined dosage forms

TLC-spectrodensitometric method was developed and validated for the simultaneous determination of policresulen (POL) and cinchocaine hydrochloride (CIN). The method is being separated on TLC aluminum plates coated with silica gel 60 F254, using chloroform:methanol:ammonia (9.5:0.6:1.0, v/v/v) as a mobile phase and Dragendorff reagent as spot detection at 490 nm. The linearity ranges of method were 0.8-20 and 0.2-3.5 µg band-1, for POL and CIN, respectively. The mean percentage recoveries were 100.46±1.1 and 99.65±0.49for POL and CIN, respectively. The proposed method was validated according to ICH guidelines and utilized for simultaneous determination of the cited drugs in their analytical mixtures and pharmaceutical preparations. Limits of detection were 0.23 and 0.07 µg band-1 for POL and CIN, respectively. The obtained results were statistically compared with that of the official and reported methods. Comparisons were starting to show that there is no significant difference regarding both accuracy and precision. The method was found to be precise, rapid, specific, and accurate. Thus the method can be applied for the routine analysis of POL and CIN in their pharmaceutical formulations without prior separation.