Development and Validation of TLC-Densitometry Method for Simultaneous Estimation of Bisoprolol Fumarate and Hydrochlorothiazide in Bulk and Tablets

Pradip N Bhoya

doi:10.4172/2157-7064.1000163

Abstract

A new simple, precise, accurate and selective TLC-densitometry method has been developed for simultaneous determination of bisoprolol fumarate and hydrochlorothiazide in tablet dosage form. Chromatographic separation was performed on aluminum plate precoated with silica gel 60F254, using chloroform: ethanol: glacial acetic acid 5:1.5:0.2 (v/v) as mobile phase. Detection was carried out densitometrically at 225 nm. The R value of bisoprolol fumarate and hydrochlorothiazide were 0.62 and 0.40, respectively. The reliability of the method was assessed by evaluation of linearity which was found to be 200–1200 ng/spot for bisoprolol fumarate and 100-800 ng/spot for hydrochlorothiazide. Accuracy of the method was accessed by % recovery and found to be 100.02 ± 1.14% for bisoprolol fumarate and 99.91 ± 0.96% for hydrochlorothiazide. The method can be used for routine analysis of bisoprolol fumarate and hydrochlorothiazide in tablet dosage form.

Highlights

Bisoprolol fumarate (BF), (+/-) -1-(4-((2-(-methyl ethoxy) ethoxy) methyl) phenoxy)-3-((1-methylethyl) amino)-2- propanol (e)-2butendioate is a competitive beta (1) - selective adrenergic antagonist [1]
An accurately weighed quantity 10 mg each of BF and HCTZ were transferred to two different 10 ml volumetric flasks, dissolved in methanol and volume was made up to mark with the same solvent to obtain concentration 1000 ng/μl each
Aliquots of standard solution 0.2, 0.4, 0.6, 0.8, 1.0 and 1.2 μl of BF and 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7 and 0.8 μl of HCTZ were applied on TLC plate with the help of microlitre syringe, using Linomat 5 sample applicator

Summary

Introduction

Bisoprolol fumarate (BF), (+/-) -1-(4-((2-(-methyl ethoxy) ethoxy) methyl) phenoxy)-3-((1-methylethyl) amino)-2- propanol (e)-2butendioate is a competitive beta (1) - selective adrenergic antagonist [1]. An accurately weighed quantity 10 mg each of BF and HCTZ were transferred to two different 10 ml volumetric flasks, dissolved in methanol and volume was made up to mark with the same solvent to obtain concentration 1000 ng/μl each. Aliquots of standard solution 0.2, 0.4, 0.6, 0.8, 1.0 and 1.2 μl of BF and 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7 and 0.8 μl of HCTZ were applied on TLC plate with the help of microlitre syringe, using Linomat 5 sample applicator.

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Results

Conclusion