Abstract:
Sensitive, accurate and precise methods were developed for the simultaneous estimation of
Adapalene and Azithromycin in bulk and in anti acne gel formulation. A UV solvent
extraction method has been developed, validated as per ICH guideline and was used for
estimation of Adapalene and azithromycin in gel formulation. Solvents used for solvent
extraction method were methanol and 0.2 N Sodium hydroxide. Both Adapalene and
Azithromycin were detected at wavelength maxima of 318 nm and 219 nm respectively.
The method was found to be linear in the range of 3-18 μg/ml and 15-90 μg/ml for
Adapalene and Azithromycin respectively. The RP-HPLC method has shown adequate
separation for Adapalene and Azithromycin in formulation. The separation was achieved
on Phenomenex C18, (250mm x 4.6mm), 5 μm column, using a mobile phase consisting
of Acetonitrile, Tetrahydrofuran, water and trifluoroacetic acid in ratio of
72:18:10:0.02v/v respectively at a flow rate of 0.7 ml/min, Injection volume 20μl with detection wavelength of 215 nm. The described method was linear over a range of 30-105
μg/ml for Adapalene and 600-2100 μg/ml for Azithromycin. The correlation coefficient
for Adapalene and Azithromycin were found to be 0.9987 and 0.9989 respectively.
Proposed method was validated as per ICH guidelines for linearity, accuracy, precision,
specificity and LOD and LOQ and was used for estimation of Adapalene and
Azithromycin in gel dosage form and results were found to be satisfactory. Thus the
developed and validated method can be used successfully in formulations.
