Abstract
A simple, economic, selective, precise, and stability-indicating high-performance thin-layer chromatographic method for analysis of tamsulosin hydrochloride, both as a bulk drug and in formulations, was developed and validated according to ICH guidelines. The method employed HPTLC aluminium plates precoated with silica gel 60F-254 as the stationary phase while the solvent system consisted of toluene : methanol : triethylamine (3.5 : 1.2 : 0.2 v/v). The system was found to give compact spot for drug ( value of ). Densitometric analysis of tamsulosin was carried out in the absorbance mode at 280 nm. The linear regression analysis data for the calibration plots showed good linear relationship, with respect to peak area in the concentration range 400–2400 ng per spot. The mean value ± SD of slope and intercept were and with respect to peak area. The method was validated for precision, recovery, and robustness. The limits of detection and quantitation were 20.49 and 62.10 ng per spot, respectively. Tamsulosin was subjected to hydrolysis, oxidation, and thermal degradation which indicate the drug is susceptible to hydrolysis, oxidation, and heat. Statistical analysis proves that the method is repeatable, selective, and accurate for the estimation of tamsulosin.
Highlights
Benign prostate hyperplasia (BPH) is a common condition in ageing men
Literature survey reveals the chiral separation by electrophoresis [3, 4], UV [5], and HPLC methods [6,7,8], coupled with ESI-MS-MS are reported for the estimation of tamsulosin hydrochloride with its impurities in bulk and pharmaceutical formulations [9] as well as in biological fluids [10,11,12,13,14,15,16,17]
The present work deals with HPTLC stability for tamsulosin hydrochloride in bulk and pharmaceutical formulation which is economical and intended for better reproducibility of degraded products, and this work is genuine as it is not used by any other author
Summary
Benign prostate hyperplasia (BPH) is a common condition in ageing men. Chemically, tamsulosin hydrochloride is [(−)(R)-5-[2-[[2-(O-ethoxyphenoxy)ethyl]amino]propyl]-2-methoxybenzenesulfonamide] and is official in Martindale— The Extra Pharmacopoeia and Merck Index [1, 2]. Tamsulosin hydrochloride exists in two enantiomeric forms, but only R-isomer is the pharmaceutically active component. It is a new type of highly selective α-1-adrenergic receptor antagonist for treatment of BPH. Compared to other α-antagonists, tamsulosin hydrochloride has greater specificity for α-1 receptors in the human prostate and does not affect receptors on blood vessels. It is the most frequently prescribed medication for the treatment of lower urinary tract symptoms. The present work deals with HPTLC stability for tamsulosin hydrochloride in bulk and pharmaceutical formulation which is economical and intended for better reproducibility of degraded products, and this work is genuine as it is not used by any other author
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