Rapid, sensitive, cost effective and reproducible stability-indicating derivative spectrophotometric methods have been developed for the estimation of dronedarone HCl employing peak–zero (P–0) and peak–peak (P–P) techniques, and their stability-indicating potential assessed in forced degraded solutions of the drug. The methods were validated with respect to linearity, accuracy, precision and robustness. Excellent linearity was observed in concentrations 2–40 μg/ml (r 2 = 0.9986). LOD and LOQ values for the proposed methods ranged from 0.42–0.46 μg/ml and 1.21–1.27 μg/ml, respectively, and excellent recovery of the drug was obtained in the tablet samples (99.70 ± 0.84%).
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References
K. M. Dale and C. M. White, Ann. Pharmacother., 41, 599–605 (2007).
S. J. Connolly, A. J. Camm, and J. L. Halperin, N. Engl. J. Med., 365, 2268–2276 (2011).
W. Tsang and R. L. Houlden, Can. J. Cardiol., 25, 421–424 (2009).
N. Penugonda, A. Mohmand-Borkowski, and J. F. Burke, Clev. Clin. J. Med., 78, 179–185 (2011).
A. Patel and J. Akhtar, J. Chem. Pharm. Res., 4, 2173–2179 (2012).
C. Xie, S. L. Yang, D. F. Zhong, X. J. Dai, and X. Y. Chen, J. Chromatogr. B, 879(28):3071–3075 (2011).
R. W. Bolderman, J. J. R. Hermans, and J. G. Maessen, J. Chromatogr. B, 877, 1727–1731 (2009).
B. Dabhi, Y. Jadeja, M. Patel, H. Jebaliya, D. Karia, A. Shah, Sci. Pharm., 81, 115–122 (2013).
K. Pravalika, M. Sudhakar, and A. Fathima, World J. Pharm. Sci., 1, 15–18 (2013).
A. Patel, J. Akhtar, and C. Sharma, Asian J. Biochem. Pharm. Res., 1, 261–277 (2012).
ICH, Stability testing of new drug substances and products, Q1A(R2), in: International Conference on Harmonisation, IFPMA, Geneva, 2003.
P. Sun, K. Pan, and Y. Wu, Dronedarone Solid Dispersion and Preparation Method Thereof, U.S. Patent US20130123353 A1 (2013).
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Published in Zhurnal Prikladnoi Spektroskopii, Vol. 83, No. 2, pp. 310–314, March–April, 2016.
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Chadha, R., Bali, A. Development and Validation of Stability-Indicating Derivative Spectrophotometric Methods for Determination of Dronedarone Hydrochloride. J Appl Spectrosc 83, 288–293 (2016). https://doi.org/10.1007/s10812-016-0283-4
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DOI: https://doi.org/10.1007/s10812-016-0283-4