Development and Validation of HPTLC Method for Studying Stress Degradation of Aspirin in Fulvic Acid Inclusion Complex

A new, precise high performance thin layer chromatographic (HPTLC) method for the analysis aspirin (ASP) in inclusion complexes with HPβCD and fulvic acid (FA) was developed and validated as per ICH guidelines. A precoated silica gel aluminium plate 60F-254 and a mixture of solvents, toluene: ethylacetate: formic acid (5:4:1 v/v) were used as stationary and mobile phase, respectively. This developed method was found to give an excellent defined sharp peak at a retention factor (RF) value of 0.52 ± 0.001. The LOQ and LOD values were found 35.29 and 123.54 ng / spot, respectively. The spray dried inclusion complexes of ASP/HPβCD and ASP/FA in the molar ratio 1:1, were subjected for forced degradation under stress conditions, and a significant reduction of ASP degradation were noted in complexed ASP as compared to ASP alone.