DETERMINATION OF ACITRETIN IN PHARMACEUTICAL FORMULATIONS BY HPLC METHOD
Keywords:Acitretin, HPLC, Validation, ICH
Acitretin is in a group of medicines called retinoids. It is used in severe skin disorders like psoriasis and it is official in USP. Psoriasis is a skin disease affecting millions of person’s worldwide. A simple, precise and rapid HPLC method was developed for the estimation of Acitretin in pharmaceutical dosage forms. The method was carried out on a Purospher BDSC18 column(250×4.6mmid, 5µm) column using a mixture of acetic acid Buffer (pH adjusted to 4): methanol: tetrahyrofuran [12:85:3]v/v/v as a mobile phase. The flow rate was 1 ml/min and Ultra-violet detection was carried out at 354 nm. Every part of determination was performed at ambient column temperature. The retention time was 4.313 min for Acitretin. The developed method was validated for parameters like specificity, accuracy, precision, robustness as per International Conference on Harmonization guidelines. Linearity for Acitretin was in the range of 30-180µg/ml and correlation coefficient was found to be 0.999. The percentage recovery was found to be in the limit of 98.9-99.8 %. Statistical analysis of the results has been carried out revealing high accuracy and good precision. Hence this method can be of use and value for the quality control department of pharmaceutical companies manufacturing these formulations without any interference due its sensitivity, simplicity and selectivity.
Katz HI, Waalen J, Leach EE. Acitretin in psoriasis: an overview of adverse effects. J Am Acad Dermatol 1999;41:S7-12.
Lydia E. Vos, Maarten H. Vermeer, and Stan Pavel. Acitretin induces capillary leak syndrome in a patient with pustular psoriasis. J Am Acad Dermatol, vol (56), 339-342.
Zouboulis CC, Korge B, Akamatsu H, Xia LQ, Schiller S, Gollnick H, Orfanos CE. Effects of 13-cis-retinoic acid, all-trans-retinoic acid, and acitretin on the proliferation, lipid synthesis and keratin expression of cultured human sebocytes in vitro. J Invest Dermatol. 1991 May;96(5):792-7.
FG Larsen, P Jakobsen, H Eriksen, J Gronhoj, K Kragballe, F Nielsen-Kudsk…, The pharmacokinetics of acitretin and its13cis-metabolite in psoriatic patients. J Clin Pharmacol May 1, 1991 vol. 31 no. 5 477-483.
A.K. Sakhia, E. Lundanesa. etal., Quantitative determination of endogenous retinoids in mouse embryos by high-performance liquid chromatography with on-line solid-phase extraction, column switching and electrochemical detection. Journal of Chromatography A, 1998.828:451–460.
De Leenheer AP, etal., a high-performance liquid chromatographic procedure for the simultaneous determination of etretinate (Tigason), all-trans-acitretin (Neotigason) and 13-cis-acitretin in human plasma.1990.J Chromatogr. 2; 500:637-42.
Suber C, Laugeir JP, Gieger JM, Bun H, Durand A, Mailbach HI. High performance liquid chromatography of acitretin in plasma and its application to pharmacokinetic study in human subject. Pharm Res 1992;9:1365-9.
Feng S, Zhang Y, Fan J. A spectrofluorimetric method for the determina-tion of acitretin in pharmaceuticals. Chem Pap. 2009;63:484-8.
Al-mallaha NR, Buna H, Duranda A. Rapid determination of acitretin or isotretinoin and their major metabolites by high-performance liquid chromatography. Anal Lett. 1988;21:1603-18.
Park HD, Kim HK, Chun MR, Kim JW, Kim DW, Lee JH. A fully validated HPLC method for the simultaneous determination of acitretin and etretinate in plasma and its application to a pharmacokinetic study in healthy Korean subjects. Int J Clin Pharmacol Ther 2009;47:476-82.
Fayer BE, Huselton CA, Garland WA, Liberato DJ…., Quantification of acitretin in human plasma by microbore liquid chromatography-negative chemical ionization mass spectrometry. J Chromatogr. 1991 Jul 17;568(1):135-44.
Kumar A, Monif T, Khuroo A, Sasmal D, Goswami D, Lahkar VK…., Stability-indicating validation of acitretin and isoacitretin in human plasma by LC-ESI-MS/MS bioanalytical method and its application to pharmacokinetic analysis. Biomed Chromatogr. 2011 Jun;25(6):680-8.
The International Conference on Harmonization, Q2 (R1), Validation of Analytical Procedures, Text and Methodology, 2005.
How to Cite
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
Copyright © Author(s) retain the copyright of this article.