Sensitive bromatometric assay methods for finasteride in pharmaceuticals

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Main Author: B. C. Somashekar
Format: Artículo científico
Language:en
Published: Universidade Estadual Paulista Júlio de Mesquita Filho 2006
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author B. C. Somashekar
author_facet B. C. Somashekar
contents Sensitive bromatometric assay methods for finasteride in pharmaceuticals B. C. Somashekar K. Basavaiah U. R. Anilkumar V. Ramakrishna Química dyes bromate bromide tablets finasteride Three sensitive spectrophotometric methods are presented for the determination of finasteridein bulk and in tablets. The methods rely on the use of bromate-bromide reagent and three dyesnamely, methyl orange, indigocarmine and thymol blue as reagents. They involve the addition of ameasured excess of bromate-bromide reagent to finasteride in acid medium, and after the brominationreaction is judged to be complete, the unreacted bromine is determined by reacting with a fixed amountof either methylorange and measuring the absorbance at 520 nm (method A) or indigocarmine andmeasuring the absorbance at 610 nm (method B) or thymol blue and measuring the absorbance at 550nm (method C). In all the methods, the amount of insitu generated bromine reacted corresponds to theamount of finasteride. The absorbance measured at the respective wavelength is found increase linearlywith the concentration of finasteride. Beer’s law is obeyed in the ranges 0.25- 2.0, 0.5-6.0 and 1-12µg mL-1 for method A, method B and method C, respectively. The calculated molar absorptivity valuesare 5.7x104, 3.12x104 and 1.77x104 Lmol-1 cm-1 respectively, for method A, method B and methodC, and the corresponding Sandell sensitivity values are 0.0065, 0.012 and 0.021 µg cm-2. The limits ofdetection (LOD) and quantification (LOQ) are also reported for all the methods. Accuracy and, intradayand inter-day precisions of the methods were established according to the current ICH guidelines.The methods were successfully applied to the determination of finasteride in commercially availabletablets and the results were found to closely agree with the label claim. The results of the methods werestatistically compared with those of a reference method by applying Student’s t-test and F-test. Theaccuracy and reliability of the methods were further confirmed by performing recovery tests via standardaddition procedure. 2006 artículo científico 0100-4670 https://www.redalyc.org/articulo.oa?id=42931304 en http://www.redalyc.org/revista.oa?id=429 Eclética Química application/pdf Universidade Estadual Paulista Júlio de Mesquita Filho Eclética Química (Brasil) Num.3 Vol.31
format Artículo científico
id redalyc_42931304
institution Redalyc
language en
publishDate 2006
publisher Universidade Estadual Paulista Júlio de Mesquita Filho
spellingShingle Sensitive bromatometric assay methods for finasteride in pharmaceuticals
B. C. Somashekar
Química
dyes
bromate
bromide
tablets
finasteride
Sensitive bromatometric assay methods for finasteride in pharmaceuticals B. C. Somashekar K. Basavaiah U. R. Anilkumar V. Ramakrishna Química dyes bromate bromide tablets finasteride Three sensitive spectrophotometric methods are presented for the determination of finasteridein bulk and in tablets. The methods rely on the use of bromate-bromide reagent and three dyesnamely, methyl orange, indigocarmine and thymol blue as reagents. They involve the addition of ameasured excess of bromate-bromide reagent to finasteride in acid medium, and after the brominationreaction is judged to be complete, the unreacted bromine is determined by reacting with a fixed amountof either methylorange and measuring the absorbance at 520 nm (method A) or indigocarmine andmeasuring the absorbance at 610 nm (method B) or thymol blue and measuring the absorbance at 550nm (method C). In all the methods, the amount of insitu generated bromine reacted corresponds to theamount of finasteride. The absorbance measured at the respective wavelength is found increase linearlywith the concentration of finasteride. Beer’s law is obeyed in the ranges 0.25- 2.0, 0.5-6.0 and 1-12µg mL-1 for method A, method B and method C, respectively. The calculated molar absorptivity valuesare 5.7x104, 3.12x104 and 1.77x104 Lmol-1 cm-1 respectively, for method A, method B and methodC, and the corresponding Sandell sensitivity values are 0.0065, 0.012 and 0.021 µg cm-2. The limits ofdetection (LOD) and quantification (LOQ) are also reported for all the methods. Accuracy and, intradayand inter-day precisions of the methods were established according to the current ICH guidelines.The methods were successfully applied to the determination of finasteride in commercially availabletablets and the results were found to closely agree with the label claim. The results of the methods werestatistically compared with those of a reference method by applying Student’s t-test and F-test. Theaccuracy and reliability of the methods were further confirmed by performing recovery tests via standardaddition procedure. 2006 artículo científico 0100-4670 https://www.redalyc.org/articulo.oa?id=42931304 en http://www.redalyc.org/revista.oa?id=429 Eclética Química application/pdf Universidade Estadual Paulista Júlio de Mesquita Filho Eclética Química (Brasil) Num.3 Vol.31
title Sensitive bromatometric assay methods for finasteride in pharmaceuticals
topic Química
dyes
bromate
bromide
tablets
finasteride
url https://www.redalyc.org/articulo.oa?id=42931304