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Stability-indicating chromatographic methods for determination of flecainide acetate in the presence of its degradation products; isolation and identification of two of its impurities.
Biomed Chromatogr 2016; 30(10):1541-8BC

Abstract

In this work, two stability-indicating chromatographic methods have been developed and validated for determination of flecainide acetate (an antiarrhythmic drug) in the presence of its degradation products (flecainide impurities; B and D). Flecainide acetate was subjected to a stress stability study including acid, alkali, oxidative, photolytic and thermal degradation. The suggested chromatographic methods included the use of thin layer chromatography (TLC-densitometry) and high-performance liquid chromatography (HPLC). The TLC method employed aluminum TLC plates precoated with silica gel G.F254 as the stationary phase and methanol-ethyl acetate-33% ammonia (3:7:0.3, by volume) as the mobile phase. The chromatograms were scanned at 290 nm and visualized in daylight by the aid of iodine vapor. The developed HPLC method used a RP-C18 column with isocratic elution. Separation was achieved using a mobile phase composed of phosphate buffer pH 3.3-acetonitrile-triethylamine (53:47:0.03, by volume) at a flow rate of 1.0 mL/min and UV detection at 292 nm. Factors affecting the efficiency of HPLC method have been studied carefully to reach the optimum conditions for separation. The developed methods were validated according to the International Conference on Harmonization guidelines and were applied for bulk powder and dosage form. Copyright © 2016 John Wiley & Sons, Ltd.

Authors+Show Affiliations

Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Kasr el Aini Street, 11562, Cairo, Egypt.Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Kasr el Aini Street, 11562, Cairo, Egypt.Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Kasr el Aini Street, 11562, Cairo, Egypt.Analytical Chemistry Department, Faculty of Pharmacy, Future University, end of 90th St., Fifth Settlement, New Cairo, Egypt.

Pub Type(s)

Journal Article
Validation Studies

Language

eng

PubMed ID

26992079

Citation

El-Ragehy, Nariman A., et al. "Stability-indicating Chromatographic Methods for Determination of Flecainide Acetate in the Presence of Its Degradation Products; Isolation and Identification of Two of Its Impurities." Biomedical Chromatography : BMC, vol. 30, no. 10, 2016, pp. 1541-8.
El-Ragehy NA, Hassan NY, Tantawy MA, et al. Stability-indicating chromatographic methods for determination of flecainide acetate in the presence of its degradation products; isolation and identification of two of its impurities. Biomed Chromatogr. 2016;30(10):1541-8.
El-Ragehy, N. A., Hassan, N. Y., Tantawy, M. A., & Abdelkawy, M. (2016). Stability-indicating chromatographic methods for determination of flecainide acetate in the presence of its degradation products; isolation and identification of two of its impurities. Biomedical Chromatography : BMC, 30(10), pp. 1541-8. doi:10.1002/bmc.3719.
El-Ragehy NA, et al. Stability-indicating Chromatographic Methods for Determination of Flecainide Acetate in the Presence of Its Degradation Products; Isolation and Identification of Two of Its Impurities. Biomed Chromatogr. 2016;30(10):1541-8. PubMed PMID: 26992079.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Stability-indicating chromatographic methods for determination of flecainide acetate in the presence of its degradation products; isolation and identification of two of its impurities. AU - El-Ragehy,Nariman A, AU - Hassan,Nagiba Y, AU - Tantawy,Mahmoud A, AU - Abdelkawy,Mohamed, Y1 - 2016/04/06/ PY - 2015/11/19/received PY - 2016/01/26/revised PY - 2016/03/08/accepted PY - 2016/3/19/entrez PY - 2016/3/19/pubmed PY - 2017/1/31/medline KW - HPLC KW - TLC-densitometry KW - flecainide acetate KW - flecainide impurity B KW - flecainide impurity D SP - 1541 EP - 8 JF - Biomedical chromatography : BMC JO - Biomed. Chromatogr. VL - 30 IS - 10 N2 - In this work, two stability-indicating chromatographic methods have been developed and validated for determination of flecainide acetate (an antiarrhythmic drug) in the presence of its degradation products (flecainide impurities; B and D). Flecainide acetate was subjected to a stress stability study including acid, alkali, oxidative, photolytic and thermal degradation. The suggested chromatographic methods included the use of thin layer chromatography (TLC-densitometry) and high-performance liquid chromatography (HPLC). The TLC method employed aluminum TLC plates precoated with silica gel G.F254 as the stationary phase and methanol-ethyl acetate-33% ammonia (3:7:0.3, by volume) as the mobile phase. The chromatograms were scanned at 290 nm and visualized in daylight by the aid of iodine vapor. The developed HPLC method used a RP-C18 column with isocratic elution. Separation was achieved using a mobile phase composed of phosphate buffer pH 3.3-acetonitrile-triethylamine (53:47:0.03, by volume) at a flow rate of 1.0 mL/min and UV detection at 292 nm. Factors affecting the efficiency of HPLC method have been studied carefully to reach the optimum conditions for separation. The developed methods were validated according to the International Conference on Harmonization guidelines and were applied for bulk powder and dosage form. Copyright © 2016 John Wiley & Sons, Ltd. SN - 1099-0801 UR - https://www.unboundmedicine.com/medline/citation/26992079/Stability_indicating_chromatographic_methods_for_determination_of_flecainide_acetate_in_the_presence_of_its_degradation_products L2 - https://doi.org/10.1002/bmc.3719 DB - PRIME DP - Unbound Medicine ER -