Author: Maged Saad Abdel-Kader, Prawez Alam and Saleh Ibrahim Alqasoumi
Publishing Date: 2016
Volume: 29 Issue: 2
Two simple, preciseand stability-indicating densitometric HPTLC method were developed and validated for qualitative and quantitative analysis of Coenzyme Q10in pharmaceutical formulations using normal-phase (Method I) and reversed phase (Method II) silica gel TLC plates. Both methods were developed and validated with 10×20cm glassbacked plates coated with 0.2mm layers of either silica gel 60 F254 (E-Merck, Germany) using hexane-ethyl acetate (8.5:1.5v/v) as developing system (Method I) or RP-18 silica gel 60 F254 (E-Merck, Germany) using methanol-acetone (4:6v/v) as mobile phase (Method II). Both analyses were scanned with a densitometer at 282 nm. Linearity was found in the ranges 50-800ng/spot (r2=0.9989) and 50-800ng/spot (r2=0.9987) for Method I and Method II respectively. Stability of Coenzyme Q10 was explored by the two methods using acid, base, hydrogen peroxide, temperature and different solvents. Due to the efficiency of the method in separating Coenzyme Q10 from other ingredients including its degradation products, it can be applied for quality control, standardization of different pharmaceutical formulations and stability study.
KEYWORDS: Coenzyme Q10; HPTLC densitometry; ICH guidelines; qualitative; quantitative; stability.