A Validated Stability Indicating HPTLC Method for Determination of Aspirin and Clopidogrel Bisulphate in Combined Dosage Form

Abstract

A sensitive, selective, precise and stability indicating (in accordance with ICH guidelines) HighPerformance Thin Layer Chromatographic method of analysis for Aspirin and Clopidogrel bisulphate
was developed, to resolve drugs response from that of their degradation products. The method
employed TLC aluminum plates precoated with silica gel 60 F254 as the stationary phase. The solvent
system consisted of carbon tetrachloride-acetone (6: 2.4 v/v). This system was found to give compact
spots for both Aspirin and Clopidogrel bisulphate (Rf value 0.13±0.02, 0.78±0.02 respectively). Both
the drugs were subjected to stress test conditions like acid/ alkali/ neutral hydrolysis, oxidation, dry
heat treatment and photo degradation. The spots for product of degradation were well resolved from
the spot of respective drugs. Densitometric analysis of drugs was carried out in the absorbance mode
at 220 nm. The linear regression data for the calibration plots showed good linear relationship with r2
0.9991 and 0.9866 in the concentration range of 200-600 ng/spot and 300-600 ng/spot for Aspirin and
Clopidogrel bisulphate, respectively. The results indicate that the drugs are susceptible to degradation,
to different extent in different conditions.