Abstract
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.
Highlights
Aspirin (ASP) is chemically acetyl salicylic acid, a very old medication with high medical values, which possess various activities viz, antiinflammartory, analgesic, and anti-aggregatory activity [1,2]
The carboxyl and ester groups are present in the structure of acetyl salicylic acid, the ester group of ASP is sensitive to hydrolysis in the presence of moisture, which reduces its bioavailability and causes ulceration effects on the human stomach [3,4,5,6]
The interior of fulvic acid (FA) is hydrophobic in nature similar to Hydroxy propyl-β-cyclodextrin (HPβCD), which are capable of forming inclusion complexes with non-polar drugs with poor solubility/stability
Summary
Aspirin (ASP) is chemically acetyl salicylic acid, a very old medication with high medical values, which possess various activities viz, antiinflammartory, analgesic, and anti-aggregatory activity [1,2]. The chemical structures of HPβCD suggest that these have structures exhibiting a hydrophilic exterior and a hydrophobic interior The interior of this HPβCD is capable of forming inclusion complexes with non-polar solutes and drug molecules with low bioavailability. These drug molecules can be entrapped in the hydrophobic interior so as to increase their solubility and dissolution rate, thereby enhancing their bioavailability. The interior of FA is hydrophobic in nature similar to HPβCD, which are capable of forming inclusion complexes with non-polar drugs with poor solubility/stability. The drug molecules can be entrapped inside the hydrophobic cavity of FA extracted from shilajit, to increase their solubility, dissolution, stability and bioavailability [15,16,17,18].
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