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Stability-Indicating High Performance Thin Layer Chromatography Determination of Alfuzosin Hydrochloride in Bulk Drug and Pharmaceutical Formulations.
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| Author:
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UPLOADED BY-ADMIN, M P PATEL, A S MEHTA, P V PATEL, V K MANDOWARA, M B PATEL
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| Abstract:
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A simple, selective, precise and stability-indicating high performance thin layer chromatographic
method of analysis of Alfuzosin hydrochloride both as a bulk drug and in formulations
is developed and validated. The method employed TLC aluminum plates precoated with silica
gel 60F-254 as the stationary phase. The solvent system consists of toluene
/methanol/Triethylamine (3: 1: 0.2 v/v/v). Densitometry analysis of Alfuzosin hydrochloride has
been carried out in the absorbance mode at 245 nm. This system gives compact spots for alfuzosin
HCl (Rf value of 0.63 ± 0.02, for seven replicates). Alfuzosin hydrochloride was subjected to
acid and alkali hydrolysis, oxidation, dry and wet heat treatment and photo degradation. The
drug undergoes degradation via oxidation, also gets affected in alkaline conditions and shows
extra peaks at 0.1 and 0.33 Rf respectively. As the method can effectively separate the drug from
its degradation products, it can be employed as a stability-indicating one. The linear regression
analysis data for the calibration spots shows good relationship with r2 = 0.9967±0.51 in the range
of 50 – 400 ng per spot. The mean values of co-relation coefficient, slope and intercept are
0.996±0.001, 14.46±0.058 and 445.99±2.16 respectively. Experimentally, the LOD and LOQ
were 20 and 50 ng/spot, respectively. Statistical analysis proves that the method is repeatable and
specific for the estimation of Alfuzosin hydrochloride. Moreover, the proposed HPTLC method
was utilized to investigate the kinetics of alkali degradation process. Arrheniu0s plot was constructed
and activation energy was calculated.
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| Keyword:
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HPTLC, Alfuzosin HCl, Stability study, Degradation
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| DOI:
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