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Resolution and Quantitation of Triamcinolone Acetonide and Its Coformulated Drug in the Presence of Its Impurities and Degradation Products by HPTLC and HPLC.
J AOAC Int 2018; 101(4):981-991JA

Abstract

Two specific, sensitive, and precise stability-indicating chromatographic methods have been developed for the determination of triamcinolone acetonide (TMC) and its coformulated drug, econazole nitrate (ECZ), in the presence of TMC impurities and degradation products. The first method was based on HPTLC-spectrodensitometry in which resolution and quantitation was achieved by using silica gel 60 F254 HPTLC plates and an ethyl acetate-tetrahydrofuran-ammonia mobile phase (10.0 + 7.0 + 0.1, v/v/v). The second method was a reversed-phase HPLC method in which separation was achieved using an acetonitrile-methanol-0.05 M potassium dihydrogen phosphate mobile phase, pH 3.0 (25.0 + 15.0 + 60.0, v/v/v). In both methods, the separated components were detected at 225 nm. Validation of both methods was conducted in compliance with International Conference on Harmonization (ICH) guidelines, and system suitability was confirmed. The linearity ranges were 0.20-28.00 and 0.50-55.00 µg/band for TMC and ECZ by HPTLC, whereas for HPLC, the range was 0.05-30.00 and 1.00-40.00 µg/mL for both drugs, respectively. The methods were successfully applied for the analysis of a pharmaceutical formulation and were compared with the reported method with no significant difference.

Authors+Show Affiliations

Cairo University, Faculty of Pharmacy, Analytical Chemistry Department, 11562 Kasr El-Aini St, Cairo, Egypt.Cairo University, Faculty of Pharmacy, Analytical Chemistry Department, 11562 Kasr El-Aini St, Cairo, Egypt.National Organization for Drug Control and Research, 6 Abu Hazem St, El-Haram St, Giza, Egypt.Cairo University, Faculty of Pharmacy, Analytical Chemistry Department, 11562 Kasr El-Aini St, Cairo, Egypt.National Organization for Drug Control and Research, 6 Abu Hazem St, El-Haram St, Giza, Egypt.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

28903833

Citation

Abbas, Samah S., et al. "Resolution and Quantitation of Triamcinolone Acetonide and Its Coformulated Drug in the Presence of Its Impurities and Degradation Products By HPTLC and HPLC." Journal of AOAC International, vol. 101, no. 4, 2018, pp. 981-991.
Abbas SS, Hegazy MA, Hendawy HAM, et al. Resolution and Quantitation of Triamcinolone Acetonide and Its Coformulated Drug in the Presence of Its Impurities and Degradation Products by HPTLC and HPLC. J AOAC Int. 2018;101(4):981-991.
Abbas, S. S., Hegazy, M. A., Hendawy, H. A. M., Weshahy, S. A., & Abdelwahab, M. H. (2018). Resolution and Quantitation of Triamcinolone Acetonide and Its Coformulated Drug in the Presence of Its Impurities and Degradation Products by HPTLC and HPLC. Journal of AOAC International, 101(4), pp. 981-991. doi:10.5740/jaoacint.16-0422.
Abbas SS, et al. Resolution and Quantitation of Triamcinolone Acetonide and Its Coformulated Drug in the Presence of Its Impurities and Degradation Products By HPTLC and HPLC. J AOAC Int. 2018 Jul 1;101(4):981-991. PubMed PMID: 28903833.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Resolution and Quantitation of Triamcinolone Acetonide and Its Coformulated Drug in the Presence of Its Impurities and Degradation Products by HPTLC and HPLC. AU - Abbas,Samah S, AU - Hegazy,Maha A, AU - Hendawy,Hassan A M, AU - Weshahy,Soheir A, AU - Abdelwahab,May H, Y1 - 2017/09/14/ PY - 2017/9/15/pubmed PY - 2018/11/2/medline PY - 2017/9/15/entrez SP - 981 EP - 991 JF - Journal of AOAC International JO - J AOAC Int VL - 101 IS - 4 N2 - Two specific, sensitive, and precise stability-indicating chromatographic methods have been developed for the determination of triamcinolone acetonide (TMC) and its coformulated drug, econazole nitrate (ECZ), in the presence of TMC impurities and degradation products. The first method was based on HPTLC-spectrodensitometry in which resolution and quantitation was achieved by using silica gel 60 F254 HPTLC plates and an ethyl acetate-tetrahydrofuran-ammonia mobile phase (10.0 + 7.0 + 0.1, v/v/v). The second method was a reversed-phase HPLC method in which separation was achieved using an acetonitrile-methanol-0.05 M potassium dihydrogen phosphate mobile phase, pH 3.0 (25.0 + 15.0 + 60.0, v/v/v). In both methods, the separated components were detected at 225 nm. Validation of both methods was conducted in compliance with International Conference on Harmonization (ICH) guidelines, and system suitability was confirmed. The linearity ranges were 0.20-28.00 and 0.50-55.00 µg/band for TMC and ECZ by HPTLC, whereas for HPLC, the range was 0.05-30.00 and 1.00-40.00 µg/mL for both drugs, respectively. The methods were successfully applied for the analysis of a pharmaceutical formulation and were compared with the reported method with no significant difference. SN - 1944-7922 UR - https://www.unboundmedicine.com/medline/citation/28903833/Resolution_and_Quantitation_of_Triamcinolone_Acetonide_and_Its_Coformulated_Drug_in_the_Presence_of_Its_Impurities_and_Degradation_Products_by_HPTLC_and_HPLC_ L2 - https://www.ingentaconnect.com/openurl?genre=article&issn=1060-3271&volume=101&issue=4&spage=981&aulast=Abbas DB - PRIME DP - Unbound Medicine ER -