Tags

Type your tag names separated by a space and hit enter

Chromatographic Study of Azintamide in Bulk Powder and in Pharmaceutical Formulation in the Presence of Its Degradation Form.
J AOAC Int 2017; 100(2):422-428JA

Abstract

Two specific, sensitive, and precise stability-indicating chromatographic methods were developed, optimized, and validated for the determination of Azintamide (AZ) in the presence of its degradation product. The first method was TLC combined with the densitometric determination of the separated bands. Separation was achieved using silica gel 60 F254 TLC plates and chloroform-acetone-glacial acetic acid (7.5 + 2.1 + 0.4, v/v/v) as the developing system. Good correlations were obtained between the integrated peak area of the studied drug and its corresponding concentrations in the linearity range. The second method used HPLC with UV diode-array detection, in which the proposed method was applied for the quantitative determination of AZ in the presence of its acidic degradation product and the quantitative determination of the acid-induced degradation product of AZ (AZ Deg) using pentoxifylline as the internal standard. The proposed components were separated on a reversed-phase C18 analytical column using acetonitrile-water (50 + 50, v/v). The flow rate was maintained at 0.55 mL/min and the detection wavelength was 260 nm. Linear regressions were obtained in the range of 1-30 and 0.3-16 μg/mL for AZ and AZ Deg, respectively. Different parameters affecting the suggested methods were optimized for maximum separation of the cited components. The suggested methods were validated in compliance with the International Conference on Harmonization guidelines and successfully applied for the determination of AZ in its pure powder form and in its pharmaceutical formulation. Both methods were also statistically compared with the reported method with no significant difference in performance observed.

Authors+Show Affiliations

Cairo University, Faculty of Pharmacy, Analytical Chemistry Department, Kasr El-Aini St, 11562 Cairo, Egypt.Misr University for Science and Technology, Faculty of Pharmacy, Analytical Chemistry Department, Al-Motamayez District, PO Box 77, 6th of October City, Egypt.Misr University for Science and Technology, Faculty of Pharmacy, Analytical Chemistry Department, Al-Motamayez District, PO Box 77, 6th of October City, Egypt.Tanta University, Faculty of Pharmacy, Analytical Chemistry Department, El-Guish St, 31111 Tanta, Egypt.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

28118567

Citation

Hegazy, Maha A., et al. "Chromatographic Study of Azintamide in Bulk Powder and in Pharmaceutical Formulation in the Presence of Its Degradation Form." Journal of AOAC International, vol. 100, no. 2, 2017, pp. 422-428.
Hegazy MA, Hassanain WA, Abdel Fattah LE, et al. Chromatographic Study of Azintamide in Bulk Powder and in Pharmaceutical Formulation in the Presence of Its Degradation Form. J AOAC Int. 2017;100(2):422-428.
Hegazy, M. A., Hassanain, W. A., Abdel Fattah, L. E., & El-Fatatry, H. M. (2017). Chromatographic Study of Azintamide in Bulk Powder and in Pharmaceutical Formulation in the Presence of Its Degradation Form. Journal of AOAC International, 100(2), pp. 422-428. doi:10.5740/jaoacint.16-0049.
Hegazy MA, et al. Chromatographic Study of Azintamide in Bulk Powder and in Pharmaceutical Formulation in the Presence of Its Degradation Form. J AOAC Int. 2017 Mar 1;100(2):422-428. PubMed PMID: 28118567.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Chromatographic Study of Azintamide in Bulk Powder and in Pharmaceutical Formulation in the Presence of Its Degradation Form. AU - Hegazy,Maha A, AU - Hassanain,Waleed A, AU - Abdel Fattah,Laila E, AU - El-Fatatry,Hamed M, Y1 - 2016/11/15/ PY - 2017/1/25/pubmed PY - 2017/6/7/medline PY - 2017/1/25/entrez SP - 422 EP - 428 JF - Journal of AOAC International JO - J AOAC Int VL - 100 IS - 2 N2 - Two specific, sensitive, and precise stability-indicating chromatographic methods were developed, optimized, and validated for the determination of Azintamide (AZ) in the presence of its degradation product. The first method was TLC combined with the densitometric determination of the separated bands. Separation was achieved using silica gel 60 F254 TLC plates and chloroform-acetone-glacial acetic acid (7.5 + 2.1 + 0.4, v/v/v) as the developing system. Good correlations were obtained between the integrated peak area of the studied drug and its corresponding concentrations in the linearity range. The second method used HPLC with UV diode-array detection, in which the proposed method was applied for the quantitative determination of AZ in the presence of its acidic degradation product and the quantitative determination of the acid-induced degradation product of AZ (AZ Deg) using pentoxifylline as the internal standard. The proposed components were separated on a reversed-phase C18 analytical column using acetonitrile-water (50 + 50, v/v). The flow rate was maintained at 0.55 mL/min and the detection wavelength was 260 nm. Linear regressions were obtained in the range of 1-30 and 0.3-16 μg/mL for AZ and AZ Deg, respectively. Different parameters affecting the suggested methods were optimized for maximum separation of the cited components. The suggested methods were validated in compliance with the International Conference on Harmonization guidelines and successfully applied for the determination of AZ in its pure powder form and in its pharmaceutical formulation. Both methods were also statistically compared with the reported method with no significant difference in performance observed. SN - 1944-7922 UR - https://www.unboundmedicine.com/medline/citation/28118567/Chromatographic_Study_of_Azintamide_in_Bulk_Powder_and_in_Pharmaceutical_Formulation_in_the_Presence_of_Its_Degradation_Form_ L2 - https://www.ingentaconnect.com/openurl?genre=article&issn=1060-3271&volume=100&issue=2&spage=422&aulast=Hegazy DB - PRIME DP - Unbound Medicine ER -