Simultaneous Estimation of Ambroxol Hydrochloride and Cetirizine Hydrochloride in Pharmaceutical Tablet Dosage Form by Simultaneous Equation Spectrophotometric Method: A Quality Control Tool for Dissolution Studies

Deepak Sharma,Dinesh Kumar,Gurmeet Singh,Mankaran Singh

doi:10.1155/2014/236570

Deepak Sharma, Dinesh Kumar + Show 2 more

Open Access

https://doi.org/10.1155/2014/236570

Copy DOI

Abstract

Ambroxol Hydrochloride and Cetirizine Hydrochloride are used for the treatment of bronchitis, cough, and allergy. A simple, economical, accurate, and precise method for simultaneous estimation of Ambroxol Hydrochloride and Cetirizine Hydrochloride in tablet dosage form has been developed. Simultaneous equation method based on measurement of absorbance at two wavelengths, that is, 244 nm and 230 nm, λmax of Ambroxol Hydrochloride and Cetirizine Hydrochloride in pH 6.8 phosphate buffer. Both of these drugs obeyed Beer-Lambert’s law in the concentration range of 2–18 µg/mL for Ambroxol Hydrochloride and 2–20 µg/mL for Cetirizine Hydrochloride. The high values of correlation coefficient (R) indicated good linearity of calibration curve for both the drugs. The accuracy and precision of method were determined and the method was validated statistically. Result of percentage recovery study confirms the accuracy of proposed method. As per the ICH guidelines, the method validation parameters checked were linearity, accuracy, precision, and assay of drug formulation. Based on the results obtained, it can be concluded that the proposed simultaneous equation spectrophotometric method for simultaneous estimation of Ambroxol Hydrochloride and Cetirizine Hydrochloride is rapid, economical, accurate, precise, and reproducible. Hence, the proposed method can be employed for quantitative estimation of Ambroxol Hydrochloride and Cetirizine Hydrochloride from their tablet dosage form.

Highlights

Ambroxol Hydrochloride [AMB HCl] (Figure 1) officially in Indian Pharmacopoeia (IP) is chemically trans-4-[(2-amino3, 5-dibromobenzyl) amino]-cyclohexanol Hydrochloride
AMB HCl showed absorption maximas one at 244 nm and another one at 308 nm, respectively. 244 nm was selected as λmax of Ambroxol Hydrochloride
From the overlain spectra of Ambroxol Hydrochlorideand Cetirizine Hydrochloride (Figure 3), two wavelengths 244 nm and 230 nm and λmax of Ambroxol Hydrochlorideand Cetirizine Hydrochloride were selected for further spectroscopic studies

Summary

Introduction

Ambroxol Hydrochloride [AMB HCl] (Figure 1) officially in Indian Pharmacopoeia (IP) is chemically trans-4-[(2-amino3, 5-dibromobenzyl) amino]-cyclohexanol Hydrochloride. It is a white or yellowish crystalline powder. Ambroxol Hydrochloride is a potent mucolytic and mucokinetic, capable of inducing bronchial secretion It depolymerises mucopolysaccharides directly and by liberating lysosomal enzymes network of fibres in tenacious sputum is broken. Ambroxol Hydrochloride (AMB) is semisynthetic derivative of vasicine obtained from Indian shrub Adhatoda vasica. It is a metabolic product of bromhexine, used in a variety of respiratory disorders including chronic bronchitis and used in the treatment of cough [3]

Methods

Results

Conclusion