Open AccessANALYTICAL METHOD DEVELOPMENT FOR SIMULTANEOUS DETERMINATION OF UBIDECARENONE AND VITAMIN E ACETATE IN CAPSULE DOSAGE FORM BY HPLC
Author(s) -
A. Caroline Grace,
Prabha Thangavelu,
M. Jagadeeswaran,
S. Kalyanasundaram,
T Sivakumar
Publication year - 2019
Publication title -
international journal of pharmacy and pharmaceutical sciences/international journal of pharmacy and pharmaceutical sciences
Language(s) - English
Resource type - Journals
eISSN - 2656-0097
pISSN - 0975-1491
DOI - 10.22159/ijpps.2019v11i1.30054
Subject(s) - chromatography , chemistry , dosage form , high performance liquid chromatography , relative standard deviation , resolution (logic) , correlation coefficient , methanol , hexane , vitamin , detection limit , mathematics , biochemistry , statistics , organic chemistry , artificial intelligence , computer science
Objective: To develop and validate a new simple, accurate, precise and sensitive high performance liquid chromatographic method (HPLC) method for simultaneous estimation of ubidecarenone and vitamin E acetate in capsule dosage form as per international conference on harmonization (ICH) guidelines.
Methods: The chromatographic separation of drugs were achieved using hypersil C8 column (250 mm x 4.6 mm, 5µ) in isocratic elution mode with a mobile phase of methanol: ethanol: n-hexane (80:10:10 v/v/v) at a flow rate of 1 ml/min with ultra-violet (UV) detection at 210 nm.
Results: The optimized method produced sharp peaks with good resolution, minimum tailing factor and satisfactory retention time were found to be 5.745 min and 12.565 min for vitamin E acetate and ubidecarenone respectively. The method was linear in the range of 60-180 µg/ml for ubidecarenone and 20-60 µg/ml for vitamin E acetate with a correlation coefficient of 0.999 and 0.9993 respectively. Mean recoveries observed for ubidecarenone and vitamin E acetate were 99.85% and 99.73% respectively. The percentage relative standard deviation (% RSD) of peak area for system precision, method precision, and intermediate precision were found to be less than 0.37%. The lower degree of % RSD obtained has proved that the method was precise and robust.
Conclusion: A new simple HPLC method was developed and validated as per ICH guidelines for the simultaneous estimation of ubidecarenone and vitamin E acetate and the method can be effectively applied for the routine analysis of active pharmaceutical ingredient (API) and formulations.