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Validated HPLC and HPTLC stability‐indicating methods for determination of alfuzosin hydrochloride in bulk powder and pharmaceutical formulations
Author(s) -
Salah Fayed Ahmed,
AbdelAaty Shehata Mostafa,
Hassan Nagiba Yehia,
ElWeshahy Soheir Ahmed
Publication year - 2006
Publication title -
journal of separation science
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.72
H-Index - 102
eISSN - 1615-9314
pISSN - 1615-9306
DOI - 10.1002/jssc.200600220
Subject(s) - chromatography , chemistry , high performance liquid chromatography , silica gel , forced degradation , acetonitrile , dosage form , high performance thin layer chromatography , thin layer chromatography , reversed phase chromatography
Two sensitive, selective, and precise stability‐indicating, high‐performance liquid chromatography and high‐performance thin‐layer chromatography methods have been developed for the determination of alfuzosin hydrochloride in the presence of its degradation products. Alfuzosin.HCl was subjected to stress alkaline, acidic, oxidative, thermal, and photo‐degradation. The drug could be well separated from the degradation products upon applying the two methods. Separation by HPLC was achieved using an Xterra RP 18 column and acetonitrile/0.02 M KH 2 PO 4 (pH = 3) in a ratio of 20:80 as mobile phase. The flow rate was 1 mL/min. The linearity range was 0.25 to 11 μg/mL with mean percentage recovery of 100.26 ± 1.54. The HPTLC method used ALUGRAM Nano‐SIL silica gel 60 F 254 plates; the optimized mobile phase was methanol/ammonia (100:1.2). Quantitatively the spots were scanned densitometrically at 245 nm. A second order polynomial equation was used for the regression. The range was 0.5–7 μg/spot. The mean percentage recovery was 100.13 ± 1.67. Two main degradation products were obtained in most stress conditions, separated, and identified by FT‐IR and NMR spectral analysis, from which the degradation pathway was proposed. The two methods were validated according to the International Conference on Harmonization. In addition, the HPLC method was used to study the kinetics of alkaline and acid degradation of the drug.