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Stability-Indicating HPLC and HPTLC Methods for Determination of Agomelatine and its Degradation Products.
J Chromatogr Sci 2018; 56(4):317-326JC

Abstract

Two accurate, sensitive and highly selective stability-indicating methods are developed and validated for simultaneous determination of Agomelatine (AGM) and its forced degradation products (Deg I and II). The first method is High-Performance Liquid Chromatography for separation and quantitation of AGM, Deg I and II on a C18 column (250 mm × 4.6 mm, 5 μm p.s) in isocratic mode by using a binary mixture of Potassium dihydrogen phosphate (0.05 M, pH adjusted to 2.9 with orthophosphoric acid): acetonitrile (60:40, v/v) at a flow rate of 2 mL/min. The components were detected at 230 nm over a concentration range of 0.5-10 μg/mL for AGM and 0.5-5 μg/mL for both Deg I and II. The second method is High-Performance Thin-Layer Chromatography, where AGM, Deg I and II were separated on silica gel HPTLC F254 plates using chloroform:methanol:ammonia solution (9:1:0.1, by volume) as a developing system. The separated bands were scanned at 230 nm over the concentration range of 0.2-1.2 μg/band for AGM in pure form and human plasma and 0.1-1 μg/band for both Deg I and II. The proposed methods were successfully applied for analysis of AGM in pharmaceutical formulations. The results obtained by the proposed methods were statistically compared to the reported HPLC method revealing high accuracy and good precision.

Authors+Show Affiliations

Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Beni-Suef University, Alshaheed Shehata Ahmad Hegazy St., 62514 Beni-Suef, Egypt.Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Beni-Suef University, Alshaheed Shehata Ahmad Hegazy St., 62514 Beni-Suef, Egypt.Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Kasr El-Aini St., 11562 Cairo, Egypt.Medicolegal Authority, Justice Ministry, 114 Bairam El Tounsy St., El Sayeda Zeinab, 11647 Cairo, Egypt.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

29342234

Citation

Abdelrahman, Maha M., et al. "Stability-Indicating HPLC and HPTLC Methods for Determination of Agomelatine and Its Degradation Products." Journal of Chromatographic Science, vol. 56, no. 4, 2018, pp. 317-326.
Abdelrahman MM, Naguib IA, El Ghobashy MR, et al. Stability-Indicating HPLC and HPTLC Methods for Determination of Agomelatine and its Degradation Products. J Chromatogr Sci. 2018;56(4):317-326.
Abdelrahman, M. M., Naguib, I. A., El Ghobashy, M. R., & Ali, N. A. (2018). Stability-Indicating HPLC and HPTLC Methods for Determination of Agomelatine and its Degradation Products. Journal of Chromatographic Science, 56(4), pp. 317-326. doi:10.1093/chromsci/bmx114.
Abdelrahman MM, et al. Stability-Indicating HPLC and HPTLC Methods for Determination of Agomelatine and Its Degradation Products. J Chromatogr Sci. 2018 Apr 1;56(4):317-326. PubMed PMID: 29342234.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Stability-Indicating HPLC and HPTLC Methods for Determination of Agomelatine and its Degradation Products. AU - Abdelrahman,Maha M, AU - Naguib,Ibrahim A, AU - El Ghobashy,Mohamed R, AU - Ali,Nesma A, PY - 2015/12/21/received PY - 2018/1/18/pubmed PY - 2018/4/24/medline PY - 2018/1/18/entrez SP - 317 EP - 326 JF - Journal of chromatographic science JO - J Chromatogr Sci VL - 56 IS - 4 N2 - Two accurate, sensitive and highly selective stability-indicating methods are developed and validated for simultaneous determination of Agomelatine (AGM) and its forced degradation products (Deg I and II). The first method is High-Performance Liquid Chromatography for separation and quantitation of AGM, Deg I and II on a C18 column (250 mm × 4.6 mm, 5 μm p.s) in isocratic mode by using a binary mixture of Potassium dihydrogen phosphate (0.05 M, pH adjusted to 2.9 with orthophosphoric acid): acetonitrile (60:40, v/v) at a flow rate of 2 mL/min. The components were detected at 230 nm over a concentration range of 0.5-10 μg/mL for AGM and 0.5-5 μg/mL for both Deg I and II. The second method is High-Performance Thin-Layer Chromatography, where AGM, Deg I and II were separated on silica gel HPTLC F254 plates using chloroform:methanol:ammonia solution (9:1:0.1, by volume) as a developing system. The separated bands were scanned at 230 nm over the concentration range of 0.2-1.2 μg/band for AGM in pure form and human plasma and 0.1-1 μg/band for both Deg I and II. The proposed methods were successfully applied for analysis of AGM in pharmaceutical formulations. The results obtained by the proposed methods were statistically compared to the reported HPLC method revealing high accuracy and good precision. SN - 1945-239X UR - https://www.unboundmedicine.com/medline/citation/29342234/Stability_Indicating_HPLC_and_HPTLC_Methods_for_Determination_of_Agomelatine_and_its_Degradation_Products_ L2 - https://academic.oup.com/chromsci/article-lookup/doi/10.1093/chromsci/bmx114 DB - PRIME DP - Unbound Medicine ER -