Development and Validation of HPTLC Method for Studying Stress Degradation of Aspirin in Fulvic Acid Inclusion Complex
Md. Khalid Anwer *
Department of Pharmaceutics, College of Pharmacy, Prince Sattam Bin Abdulaziz University, Alkharj 11942, Saudi Arabia.
Mohammed Muqtader Ahmed
Department of Pharmaceutics, College of Pharmacy, Prince Sattam Bin Abdulaziz University, Alkharj 11942, Saudi Arabia.
Mohammad Javed Ansari
Department of Pharmaceutics, College of Pharmacy, Prince Sattam Bin Abdulaziz University, Alkharj 11942, Saudi Arabia.
Mohammed F. Aldawsari
Department of Pharmaceutics, College of Pharmacy, Prince Sattam Bin Abdulaziz University, Alkharj 11942, Saudi Arabia.
Mohd. Aamir Mirza
Department of Pharmaceutics, SPER, Jamia Hamdard, New Delhi, 110062, India.
*Author to whom correspondence should be addressed.
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.
Keywords: Aspirin, HPβCD, fulvic acid, inclusion complex, stability.