Applied Sciences
| Open Access |
DOI: DEVELOPMENT OF STABILITY-INDICATING SPECTROPHOTOMETRIC METHODS FOR THE QUANTITATIVE ANALYSIS OF TIEMONIUM METHYLSULPHATE IN THE PRESENCE OF DEGRADATION PRODUCTS
Samah E. Zaazaa , Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Kasr ElـAini Street, Cairo, EgyptAbstract
The development of stability-indicating analytical methods is pivotal for ensuring the quality and safety of pharmaceutical formulations. This study focuses on the quantitative analysis of Tiemonium Methylsulphate in the presence of its degradation products using spectrophotometric techniques. Tiemonium Methylsulphate, a quaternary ammonium derivative with therapeutic applications, is prone to degradation under various conditions. Degradation products can compromise the efficacy and safety of pharmaceutical products. The present research aims to establish stability-indicating methods capable of accurately quantifying Tiemonium Methylsulphate even in complex matrices with co-existing degradation products. Forced degradation studies were conducted to generate degradation products under different stress conditions. The developed spectrophotometric methods were applied to analyze these degraded samples. The methods were validated in terms of linearity, precision, accuracy, and specificity. Additionally, the limits of detection and quantification were determined. The results highlight the robustness and effectiveness of the developed stability-indicating methods in accurately quantifying Tiemonium Methylsulphate in the presence of its degradation products. These methods hold significant potential for ensuring the quality and efficacy of pharmaceutical formulations
Keywords
degradation products, stability-indicating methods, spectrophotometric analysis
References
Abdel-Kawy M, Amer SM, Lotfy HM, Zaazaa H. Simple spectrophotometric analysis of Benazepril hydrochloride or valsartan in combined dosages with Hydrochlorothiazide. Bull Fac Pharm Cairo Univ, 2006; 44: 25-32.
De Schutter, JA, De Moerloose, P. Reversed-phase ion-pair liquid chromatography of some quaternary ammonium drugs. J Pharm Biomed Anal, 1988; 6: 879-885.
Eckers C, Haskins N, Langridge J. The use of liquid chromatography combined with a quadrupole time-of-flight analyser forthe identification of trace impurities in drug substance. Rapid Commun. Mass Spectrom., 1997; 11: 1916-1922.
El- Bardicy MG, Lotfy HM, El-Sayed MA, El-Tarras MF. Smart stability-indicating spectrophotometric methods for determination of binary mixtures without prior separation. J.AOAC Int, 2008; 291-299
International Conference on Harmonization (ICH) for Registration of Pharmaceuticals for Human Use. 2003. Stability Testing of New Drug Substances and Products, ICH- Q1A(R2).
International Conference on Harmonization (ICH) of Technical Requirements for the Registration of Pharmaceuticals for Human Use. 2005. Validation of Analytical Procedures: Methodology, ICH- Q2(R1).
Lim, CK, Lord G. Current Developments in LC-MS for Pharmaceutical Analysis. J. Bio.Pharm.Bull., 2002; 25: 547-557.
Scoular IT, Monks A, Burgess C, Turner P. Human studies on the bioavailability of a quaternary ammonium compounds, tiemonium iodide and tiemonium methosulphate. Curr Med Res Opin, 1977; 4: 732-738.
Sweetman SC. 2011. Martindale, The Complete Drug Reference: The Extra Pharmacopoeia, 37 th Ed. London: The Pharmaceutical Press.
Article Statistics
Downloads
Copyright License
Copyright (c) 2023 The American Journal of Applied Sciences
This work is licensed under a Creative Commons Attribution 4.0 International License.
Authors retain the copyright of their manuscripts, and all Open Access articles are disseminated under the terms of the Creative Commons Attribution License 4.0 (CC-BY), which licenses unrestricted use, distribution, and reproduction in any medium, provided that the original work is appropriately cited. The use of general descriptive names, trade names, trademarks, and so forth in this publication, even if not specifically identified, does not imply that these names are not protected by the relevant laws and regulations.