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

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, 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 ( ) 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. 1. Introduction Ambroxol Hydrochloride [AMB HCl] (Figure 1) officially in Indian Pharmacopoeia (IP) is chemically trans-4-[(2-amino-3, 5-dibromobenzyl) amino]-cyclohexanol Hydrochloride. It is a white or yellowish crystalline powder. It is sparingly soluble in water, soluble in methanol, and practically insoluble in methylene chloride [1, 2]. 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. It is particularly useful if mucus plugs are present. 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 also used in the treatment of cough [3]. Figure 1: Chemical structure of ambroxol hydrochloride. Cetirizine Hydrochloride [CET HCl] (Figure 2) is chemically [2-[4-[(4-chlorophenyl) phenylmethyl]-1-piperazinyl]ethoxy]acetic acid and the active