Stability indicating spectrophotometric methods for quantitative determination of bromazepam and its degradation product.

Autor: Darwish HW; Department of Pharmaceutical Chemistry, College of Pharmacy, King Saud University, P.O. Box 2457, Riyadh 11451, Saudi Arabia; Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Kasr El-Aini St., Cairo 11562, Egypt., A Ali N; Toxicology Laboratory, Forensic Medicine Authority, Justice Ministry,114 Bairam El Tounsy St., El Sayeda Zeinab, 11647 Cairo, Egypt., Naguib IA; Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Beni-Suef University, Alshaheed Shehata Ahmad Hegazy St., 62514 Beni-Suef, Egypt; Department of Pharmaceutical Chemistry, College of Pharmacy, Taif University, Al-Hawiah 21974, Taif, Saudi Arabia. Electronic address: i.abdelaal@tu.edu.sa., El Ghobashy MR; Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Kasr El-Aini St., Cairo 11562, Egypt; Faculty of Pharmacy, October 6 University, October 6 City, Giza, Egypt., Al-Hossaini AM; Department of Pharmaceutical Chemistry, College of Pharmacy, King Saud University, P.O. Box 2457, Riyadh 11451, Saudi Arabia., Abdelrahman MM; Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Beni-Suef University, Alshaheed Shehata Ahmad Hegazy St., 62514 Beni-Suef, Egypt.
Jazyk: angličtina
Zdroj: Spectrochimica acta. Part A, Molecular and biomolecular spectroscopy [Spectrochim Acta A Mol Biomol Spectrosc] 2020 Sep 05; Vol. 238, pp. 118433. Date of Electronic Publication: 2020 May 05.
DOI: 10.1016/j.saa.2020.118433
Abstrakt: Four simple, sensitive and selective stability indicating spectrophotometric methods are presented for quantitative determination of the benzodiazepine drug; bromazepam (BMZ) and one of its reported potential impurities and degradation product; 2-(2-amino-5-bromobenzoyl) pyridine (ABP) in methanol. Method A, is isoabsorptive point coupled with D 0 method, where good linearity was obtained by measuring the absorbance of BMZ at 264 nm (A iso ) in the concentration range of 2-25 μg mL -1 , and the absorbance of ABP at its λ max 396 nm in concentration range of 0.5-24 μg mL -1 . Method B, is ratio subtraction; the absorbance was measured at 233 nm for BMZ using 20 μg mL -1 of ABP, while ABP was determined directly at its λ max 396 nm using methanol as a solvent. Method C, was based on measuring the total peak amplitude of the first derivative of the ratio spectra (DD 1 ) of BMZ from 301 to 326 nm using 10 μg mL -1 of ABP as a divisor and determination of ABP at peak amplitude of 293 nm using 5 μg mL -1 of BMZ as a divisor. In method D, ratio difference method, good linearity was achieved for determination of BMZ and ABP by measuring the differences between the amplitudes of ratio spectra at 312 nm and 274 nm and differences between the amplitudes of ratio spectra at 274 nm and 312 nm, respectively. The stability of BMZ was investigated under different ICH recommended forced degradation conditions. The suggested methods were then successfully applied for determination of BMZ in its pharmaceutical formulations.
Competing Interests: Declaration of competing interest Authors would like to declare absence of any conflicts of interest regarding this work. The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
(Copyright © 2020 Elsevier B.V. All rights reserved.)
Databáze: MEDLINE
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