Validated HPTLC method for the simultaneous determination of cinnarizine and dimenhydrinate in their combined dosage form

الملخص EN

A simple, rapid and selective high performance thin layer chromatography (HPTLC) method was developed for the simultaneous determination of cinnarizine (CNZ) and dimenhydrinate (DMH) in pure form and in their combined dosage form.

Reviewing the literature revealed that there are no reports for the use of TLC for the assay of this mixture.

Effective separation was achieved using Fluka HPTLC aluminum sheets of silica gel 60 F254 using chloroform–n-hexane– methanol (8.5:0.8:0.7, by volume) as mobile phase, followed by densitometric measurement of CNZ and DMH spots at 254 and 279 nm, respectively.

The reliability and analytical performance of the proposed HPTLC method were statistically validated with respect to linearity, ranges, precision, accuracy, selectivity, robustness and detection and quantification limits.

Calibration curves were linear in the ranges of 50–400 and 50–500 ng/spot for CNZ and DMH, respectively with correlation coefficients >0.9998.

The limits of detection were 8.1 and 8.0 ng/spot for CNZ and DMH respectively.

The validated HPTLC method was applied to the simultaneous analysis of CNZ and DMH in laboratory-prepared tablets.

Both analytes were successfully quantified with good recovery values, and no interference was encountered from the inactive ingredients.