Abstract
A reversed-phase high performance liquid chromatography method was validated for the determination of cefazolin sodium in lyophilized powder for solution for injection to be applied for quality control in pharmaceutical industry. The liquid chromatography method was conducted on a Zorbax Eclipse Plus C18 column (250 x 4.6 mm, 5 μm), maintained at room temperature. The mobile phase consisted of purified water: acetonitrile (60: 40 v/v), adjusted to pH 8 with triethylamine. The flow rate was of 0.5 mL min-1 and effluents were monitored at 270 nm. The retention time for cefazolin sodium was 3.6 min. The method proved to be linear (r2=0.9999) over the concentration range of 30-80 µg mL-1. The selectivity of the method was proven through degradation studies. The method demonstrated satisfactory results for precision, accuracy, limits of detection and quantitation. The robustness of this method was evaluated using the Plackett–Burman fractional factorial experimental design with a matrix of 15 experiments and the statistical treatment proposed by Youden and Steiner. Finally, the proposed method could be also an advantageous option for the analysis of cefazolin sodium, contributing to improve the quality control and to assure the therapeutic efficacy.
Highlights
Since their discovery by Brotzu in 1948, cephalosporins maintain themselves as a class of antimicrobials that stands out for their high therapeutic importance and frequency of use, because of their safety and very effective use against a large variety of microbial agents (Brunton et al, 2012)
Many methods described for Cefazolin sodium (CFZ) up to the moment are directed to its quantification in biological matrices (Wold, 1977; Bayoumi et al, 1986; Nahata, 1990; Liang et al, 1994; Bompadre et al, 1998; Al-Rawithi et al, 2000; Samer, et al, 2000; Tsai, Chen, 2000; Arayne et al, 2007; Farthing et al, 2008), requiring pretreatment of the sample, among other slow procedures, requiring sophisticated equipment and high costs and using large amounts of organic solvents which are toxic for the operators and for the environment
Many mobile phase systems were tested in different chromatographic columns
Summary
Since their discovery by Brotzu in 1948, cephalosporins maintain themselves as a class of antimicrobials that stands out for their high therapeutic importance and frequency of use, because of their safety and very effective use against a large variety of microbial agents (Brunton et al, 2012). Cefazolin sodium (CFZ) is a β-lactam semi synthetic antibiotic classified as a first-generation cephalosporin; it has been commercially available since 1970, only in the form of pharmaceutical powder for injectable solution, not having oral absorption (Bolós et al, 1987). Its use in clinical practice is distinguished for being used worldwide and keeping more than 40 years as a drug of choice for preoperative prophylaxis of various surgical procedures (Kusaba, 2009). Considering that it can be administered less frequently because of its longer half-life, a single dose of cefazolin immediately before surgery is the most widely used prophylaxis (Brunton et al, 2012), and reduces the incidence of infections that may pose serious complications in patients undergoing surgery (Wang et al, 2004). Few studies were validated for quantification of CFZ in pharmaceutical form (Moore et al, 1991; Pinto et al, 1995; Farag, 1998; Shinde et al, 1998; Lalith et al, 2010), for the control of drug quality post-production, to be performed by the industry providing security for the user
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