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INTERNATIONAL JOURNAL OF PHARMACEUTICAL RESEARCH

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IJPR included in UGC-Approved List of Journals - Ref. No. is SL. No. 4812 & J. No. 63703

Published by : Advanced Scientific Research
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0975-2366
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IJPR 9[3] July - September 2017 Special Issue

July - September 9[3] 2017

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Stability-Indicating High Performance Thin Layer Chromatography Determination of Alfuzosin Hydrochloride in Bulk Drug and Pharmaceutical Formulations.

Author: UPLOADED BY-ADMIN, M P PATEL, A S MEHTA, P V PATEL, V K MANDOWARA, M B PATEL
Abstract: 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.
Keyword: HPTLC, Alfuzosin HCl, Stability study, Degradation
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