ANALYTICAL METHOD DEVELOPMENT FOR SIMULTANEOUS DETERMINATION OF UBIDECARENONE AND VITAMIN E ACETATE IN CAPSULE DOSAGE FORM BY HPLC
DOI:
https://doi.org/10.22159/ijpps.2019v11i1.30054Keywords:
Ubidecarenone, Vitamin E acetate, HPLC, Method development, Coenzyme-Q10, alpha-tocopheryl acetateAbstract
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.
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The European Pharmacopeia. 5th ed. Strasbourg, France: EDQM, Council of Europe; 2005. p. 2157.
Astridani Rizky Putranti, Riesta Primaharinastiti, Esti Hendradi. Effectivity and physicochemical stability of nanostructured lipid carrier coenzyme Q10 in a different ratio of lipid cetyl palmitate and alpha tocopheryl acetate as a carrier. Asian J Pharm Clin Res 2017;10:146-52.
Manal Abdulkhaliq Ibrahim, Nada Naji Al-shawi. Effects of vitamin E and coenzyme Q10 supplementation against doxorubicin-induced neurotoxicity in rats. Asian J Pharm Clin Res 2018;11:402-6.
Boicelli CA, Ramponi C, Casali E, Masotti L. Ubiquinones: stereochemistry and biological implications. Membr Biochem 1981;4:105-18.
Bonakdar RA, Guarneri E. Coenzyme Q10. Am Fam Physician 2005;72:1065–70.
Mohammed Sarhan KKA, Mebin Aliasa, Sambath Kumar R. A review on novel uses of vitamin E. J Crit Rev 2017;5:10-4.
The European Pharmacopeia. 5th ed. Supplement 5.1, Strasbourg, France: EDQM, Council of Europe; 2005. p. 3024.
Sanjay Kumar Gupta, Munagala Gayatri Ramya, Rajesh Akki, Singaram Kathirvel, Vadithe Vasu Naik. Development and validation of new RP-HPLC methods for stability study of fat-soluble vitamins. Int J Pharm Pharm Sci 2013;5:71-5.
Maria Laura Colombo. An Update on Vitamin E. Tocopherol and tocotrienol—perspectives. Molecules 2010;15:2103-13.
Mailvelan R, Mounnissamy VM, Selvamani P, Rajesh J, Raviraj T. Development and validation of UV spectrophotometric methods for the simultaneous estimation of ubidecarenone (coenzyme q-10) and clomifene citrate in bulk and tablet dosage forms. Asian J Res Chem Pharm Sci 2013;1:23-30.
Karpinska J, Mikołuc B, Piotrowska Jastrzebska. J application of derivative spectrophotometry for determination of coenzyme Q10 in pharmaceuticals and plasma. J Pharm Biomed Anal 1998;17:1345–50.
The Japanese pharmacopeia. Part I. 14th ed. Ministry of health, Labour and welfare, Tokyo; 2002. p. 832.
Estevez PN, Tripodi V, Buontempo F, Lucangioli S. Coenzyme Q10 stability in pediatric liquid oral dosage formulations. Farm Hosp 2012;36:492-7.
Saravanamuthukumar M, Palanivelu M, Anandarajagopal K, Sridharan D. Simultaneous estimation and validation of atorvastatin calcium and ubidecarenone (coenzyme Q10) in combined tablet dosage form by the RP-HPLC method. Int J Pharm Pharm Sci 2010;2:36-8.
Kannappan N, Sasidharan DK, Ramkumar P, Prajapati MK, Panda PP. Analytical method development and validation of atorvastatin calcium and ubidecarenone tablet by RP-HPLC. Int J Pharm Sci Res 2011;2:1679-82.
Mailvelan R, Rajesh J, Selvamani P, Latha S. HPLC method development and validation for simultaneous estimation of ubidecarenone and clomifene citrate in bulk and tablet dosage forms. Int J Res Pharm Nano Sci 2012;1:61-9.
Claude Leray, Margaret D. Andriamampandry, monique freund, christian gachet, jean-pierre cazenave. Simultaneous determination of homologues of vitamin E and coenzyme Q and products of α-tocopherol oxidation. J Lipid Res 1998; 39:2099-105.
Debra Orozco, Jules Skamarack, Kelly Reins, Barry Titlow, Steve Lunetta, Fang Li, et al. Determination of ubidecarenone (Coenzyme Q10, Ubiquinol-10) in raw materials and dietary supplements by high-performance liquid chromatography with ultraviolet detection: single-laboratory validation. J AOAC Int 2007;90:1227-36.
Claudia Cristina Ferreiro Barros, Eduardo Kinio Sugawara, Livia Rentas Sanches. Determination of a method for extraction of coenzyme Q10 in human plasma: optimization of the use of surfactants and other variables. Einstein (São Paulo) 2012;10:203-8.
Adrian A Franke, Cynthia M Morrison, Jesse L Bakke, Laurie J Custer, Xingnan Li, Robert V Cooney. Coenzyme Q10 in human blood: native levels and determinants of oxidation during processing and storage. Free Radical Biol Med 2010;48:1610–7.
Kareti Srinivasa Rao, Nargesh K Keshar, Nikhil V Belorkar, Bhanoji Rao ME, Srinivasa K, Ajay Kumar Pattnaik. A simple and rapid HPLC method for the simultaneous determination of vitamin-a and vitamin-e in tablet dosage forms. Res J Chem Environ Sci 2013;1:2-6.
Ubaldi A, Delbono G, Fusari A, Serventi P. Quick HPLC method to determine vitamin E concentration in cowʼs milk. Ann Fac Medic Vet Di Parma 2005;25:101-10.
Anuradha SN, Arunkumar S. A validated RP–HPLC method for simultaneous estimation of vitamin a and vitamin e in multivitamin tablet dosage form. Int J Pharma Bio Sci 2012;3:322-7.
Prabakaran R, Chenthilnathan A, Vikraman S. Validation of simultaneous determination of vitamin an acetate and vitamin e acetate in multivitamin tablets by RP-HPLC. Int J Pharm Biol Chem Sci 2014;3:27-34.
Brabcova I, Kovarova L, Satinsky D, Havlikova L, Solich P. A fast HPLC method for determination of vitamin e acetate in dietary supplements using monolithic column. Food Anal Methods 2013;3:380-5.
Hong Min Lee, Byung Man Kwak, Jang Hyuk Ahn, Seung Hwan Jeong, Sung Lye Shim, Kyong Su Kim, et al. Simultaneous determination of vitamin a and e in infant formula by HPLC with photodiode array detection. Korean J Food Sci Ani Resour 2011;31:191-9.
Kumar Ashok, Rajput Gaurav Kumar. To develop a simple (UV-VIS Spectrometric) method for the estimation of multivitamin with special reference to capsules and tablets. Int J Pharm 2011;2:43-8.
Rutkowski M, Grzegorczyk K. Modifications of spectro-photometric Methods for antioxidative vitamins determination convenient in analytic practice. Acta Sci Pol Technol Aliment 2007;6:17-28.
International conference on harmonization of technical requirements for registration of pharmaceuticals for human use. Validation of analytical procedures: Text and methodology ICH Q2 (R1); 2005.
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