Abstract
A simple, rapid and sensitive isocratic high performance liquid chromatographic (HPLC) method has been developed for the estimation of purity and quantitative determination of Amiodarone HCl active pharmaceutical ingredient (API).The method describes a quantitative estimation of five process related impurities of Amiodarone HCl with a resolution of more than or near to 3.0 between each impurity. These five known related substances are estimated by a simple, rapid and accurate reverse phase isocratic HPLC method. The method has been validated for the determination of assay and related substances in Amiodarone HCl API, using a C8 column. The elution is carried out using a mobile phase consisting of water-methanol-acetic acid with a pH 5.8. For the quantitative determination of these relative substances, a relative response factors have been determined for all five related substances with respect to Amiodarone HCl. The precision (system precision, method precision and intermediated precision) is demonstrated for both the assay as well as related substances on six independent sample preparations. Accuracy of the method (recovery) is demonstrated for both Amiodarone and each of the five related substances. Specificity of the method is demonstrated by forced degradation study of Amiodarone HCl API under various stress conditions. The method is found to be stability indicating and useful for the analysis of assay and related substances of Amiodarone HCl API in a routine quality control laboratory and for the stability studies of drug substance.
This is a preview of subscription content, log in via an institution to check access.
Similar content being viewed by others
References
Juenke JM, Brown PI, McMillin GA, Urry FM (2004) J Anal Toxico 28(1):63–66
Wang F, Li HD, Zhang BK, Yuan HY (2002) Yaowu Fenxi Zazhi 22(6):450–452
Hanioka N, Saito Y, Soyama A, Ando M, Ozawa S, Sawada J (2002) Journal of Chromatogr. B: Analytical Technologies in the biomedical and Life Sciences 774(1):105–113
Al-Dhawailie AA (1995) Anal Lett 28(13):2391–2400
Pham Huy C, Costa S, Nany S, Claude JR, Hamon M (1991) Anal Lett 24(4):603–623
Christopherson MJ, Yoder KJ, Miller RB (2004) J Liq Chromatogr & Rel Technol 27(1):95–111
Thyagarajapuram N, Alexander KS (2003) J Liq Chromatogr & Rel Technol 26(8):1315–1326
United States Pharmacopeial Forum (2002) United States Pharmacopeial Convention: Rockville, MD, Vol. 28, No.3; pp. 923–926
European Pharmacopeia (2005) Council of Europe: Strasbourg Cedex. 5th ed., Vol. 2; pp. 977–978
Plomp TA (1991) Analytical profile of Amiodarone. In: Analytical Profile of Drug Substances. Academic Press Inc., New York, pp. 1–120
United States Pharmacopeia (2003) United States Pharmacopeial Convention: Rockville, MD, pp. 2442
ICH Steering Committee (1996) Validation of Analytical Procedures : Methodology Q2B, November, 6, 1996
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Khan, M.A., Kumar, S., Jayachandran, J. et al. Validation of a Stability Indicating LC Method for Amiodarone HCL and Related Substances. Chroma 61, 599–607 (2005). https://doi.org/10.1365/s10337-005-0554-3
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1365/s10337-005-0554-3