Physical Chemistry 2016, 6(3): 67-74 DOI: 10.5923/j.pc.20160603.02 Development and Validation of an Innovative Method for the Determination of Cefadroxil Monohydrate in Capsules Bianca Aparecida de Marco * , Hérida Regina Nunes Salgado Department of Pharmaceutics, School of Pharmaceutical Sciences, Universidade Estadual Paulista, Araraquara, SP, Brazil Abstract This paper describes the development and validation of an innovative method using Fourier Transform Infrared (FT-IR) transmission spectroscopy for the determination and quantification of cefadroxil monohydrate in capsules. The method was validated with no use of organic solvents and it is in accordance to the International Conference on Harmonisation guidelines, presenting great advantage over other analytical methods, because of the great contribution to the environment, green chemical and pharmaceutical industries. The method can be quantified by measuring the absorbance of the band corresponding to the carbonyl present in the drug molecule, in the region between 1800 and 1700 cm -1 , where it shows accuracy, linearity, precision, robustness and selectivity, being linear over a range of concentrations from 1.5 to 2.5 mg with correlation coefficients of 0.9990 and limit of detection and quantitation of 0.37 and 1.11 mg, respectively. This FT-IR method presents simple execution, low cost analysis and it is environmentally friendly, therefore it is very useful for routine quality control analysis of this drug. Keywords Cefadroxil, Infrared, Green Chemistry, Spectroscopy, Quantitative 1. Introduction The cefadroxil (Figure 1) is a semi-synthetic antibiotic belonging to the class of first-generation cephalosporins (DEVALIYA & JAIN, 2009; DEY et al., 2010). Its mechanism of action is due to inhibition of the synthesis of the cell wall of mainly Gram-positive bacteria being widely used for treatment of infections such as pharyngitis, tonsillitis, gonorrhea, skin infections and soft tissue, ear and urinary tract (TANRISEVER & SANTELLA, 1986). Figure 1. Chemical structure of anhydrous cefadroxil (CAS 50370-12-2) There are two known forms of cefadroxil beyond the anhydrous substance: the monohydrate form (CAS 66592-87-8) and the hemihydrate form (CAS 119922-85-9) * Corresponding author: byademarco@yahoo.com.br (Bianca Aparecida de Marco) Published online at http://journal.sapub.org/pc Copyright © 2016 Scientific & Academic Publishing. All Rights Reserved (ARGENTINA PHARMACOPOEIA, 2003; BP, 2012; BRAZILIAN PHARMACOPOEIA, 2010; EF, 2013; IP, 2007; JP, 2011; PORTUGUESE PHARMACOPOEIA, 2005; USP 37, 2014). The cefadroxil is marketed in Brazil in the form of capsules with concentration of 500 mg, tablet with concentration of 1 g and powder for suspension with concentration of 50 and 100 mg/mL (BRAZIL, 2016a, BRAZIL, 2016b). Various analytical methods are described in the literature to determine and quantify the cefadroxil (MARCO & SALGADO, 2016). Among them, there are the high performance liquid chromatography (DHOKA & CHOPADE, 2012; EL-GINDY et al., 2000; HENDRIX et al., 1993; LINDGREN, 1987; MCATEER el al., 1987; NAGARAJAN et al., 2013; RAO et al., 2014; SAMANIDOU et al., 2003; SAMANIDOU et al., 2004; SHARIF et al., 2010); ultra performance liquid chromatography (SCHMIDT & STEINER, 2012); UV absorption spectroscopy (JAIN et al., 2014; PRADIP et al., 2015); capillary electrophoresis (ANDRASI et al., 2007; AUDA et al., 2009; GÁSPÁR et al., 2002; HANCU et al., 2013; HANCU et al., 2015; HERNÁNDEZ et al., 2003; LI et al., 1998; LIU et al., 2006; MRESTANI et al., 1997; MRESTANIA et al., 1998; SHALAEVA et al., 2008; SOLANGI et al., 2007) and chemiluminescence (ALY et al., 1998; SUN et al., 2004; THONGPOON et al., 2006). However, the majority of these methods use toxic organic solvents which are harmful to the environment and operators, contributing and involving directly in the formation of toxic