Spectrophotometric methods have been developed for the determination of dothiepin hydrochloride (DOTH) in both pure and tablet dosage form and their limits of detection and quantification have been evaluated. The methods are based on the measurement of the absorbance of a DOTH solution either in 0.1 N HCl at 229 nm (method A) or in methanol at 231 nm (method B). Beer’s law is obeyed over a concentration range of 1–16 μg/ml DOTH for both methods. Molar absorptivity values are calculated to be 2.48 × 104 and 2.42 × 104 l/(mol × cm) with Sandell sensitivity values of 0.0134 and 0.0137 μg/cm2 for methods A and B, respectively. The degradation behavior of DOTH was investigated under different stress conditions such as acid hydrolysis, alkaline hydrolysis, water hydrolysis, oxidation, dry heat treatment, and UV-degradation. The drug undergoes significant degradation under oxidative conditions only.
This is a preview of subscription content, log in via an institution to check access.
Similar content being viewed by others
References
J. O. Maryadele, In: "An Encyclopedia of Chemicals, Drugs, and Biologicals. The Merck Index," 14th ed., Merck & Co., Inc., Whitehouse Station, NJ, USA (2006).
P. J. Taylor, B. G. Charles, R. Norris, P. Salm, and P. J. Ravenscroft, J. Chromatogr., 581, 152–l55 (1992).
The British Pharmacopoeia, Vol. I, HM Stationery office, London (2003).
R. T. Sane, R. V. Tendolkar, D. P. Gangal, K. D. Ladage, and R. M. Kothurkar, Indian J. Pharm. Sci., 51, 61–62 (1989).
K. Šlais and J. Šubert, J. Chromatogr. A, 191, 137–143 (1980).
W. P. A. Li and W. J. Irwin, J. Pharm. Pharmacol., 31, 512–516 (1979).
Z. Pawlak, D. Kay, and B. J. Clark, Anal. Proc. (London), 27, 16–18 (1990).
Z. Pawlak and B. J. Clark, J. Pharm. Biomed. Anal., 7, 1903–1907 (1989).
B. J. Clark, P. Barker, and T. Large, J. Pharm. Biomed. Anal., 10, 723–726 (1992).
E. Bishop and W. Hussein, Analyst, 109, 73–80 (1984).
M. M. Hosny, Taiwan Pharm. J., 59, 25–30 (2007).
N. T. Abdel-Ghani, R. M. El-Nashar, and A. A. Bioumy, Anal. Lett., 37, 3237–3254 (2004).
A. F. A. Youssef, Sci. Pharm., 73, 1–15 (2005).
N. T. Abdel-Ghani, R. M. El-Nashar, and A. A. Bioumy, FABAD J. Pharm. Sci., 29, 195–201 (2004).
H. E. Abdellatef, M. M. El-Henawee, H. M. El-Sayed, and M. M. Ayad, Spectrochim. Acta, A, 65, 1087–1092 (2006).
M. I. Walash, F. Belal, N. El-Enany, and H. Elmansi, Int. J. Biomed. Sci., 6, 327–334 (2010).
E. A. Taha, Anal. Bioanal. Chem., 376, 1131–1136 (2003).
R. T. Sane, R. M. Kothurkar, K. D. Ladage, R. V. Tendolkar, and D. P. Gangal, Indian J. Pharm. Sci., 50, 345–346 (1988).
E. A. Taha, S. M. Soliman, H. E. Abdellatef, and M. M. Ayad, Microchim. Acta, 140, 175–182 (2002).
W. E. Hassan, Chem. Pharm. Bull., 56, 1092–1096 (2008).
M. M. Hosny, Mansoura J. Pharm. Sci., 20, 64–77 (2004).
ICH Q1A, Stability Testing of New Drug Substances and Products, Int. Conf. Harmonization of Technical Requirements for the Registration of Drugs For Human Use, Geneva, Switzerland, February (2003).
S. K. Motwani, R. K. Khar, F. J. Ahmed, S. Chopra, K. Kohli, and S. Talegaonkar, Anal. Chim. Acta, 582, 75–82 (2007).
Int. Conf. Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonised Tripartite Guideline, Validation of Analytical Procedures: Text and Methodology Q2(R 1), Complementary Guideline on Methodology 06 November 1996, London; incorporated in November 2005.
Author information
Authors and Affiliations
Corresponding author
Additional information
Published in Zhurnal Prikladnoi Spektroskopii, Vol. 79, No. 5, pp. 788–794, September–October, 2012.
Rights and permissions
About this article
Cite this article
Abdulrahman, S.A.M., Basavaiah, K., Cijo, M.X. et al. Validation of UV spectrophotometric methods for the determination of dothiepin hydrochloride in pharmaceutical dosage form and stress degradation studies. J Appl Spectrosc 79, 780–787 (2012). https://doi.org/10.1007/s10812-012-9670-7
Received:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s10812-012-9670-7