AN OVERVIEW OF CEFIXIME TRIHYDRATE & POTASSIUM CLAVULANATE FIXED-DOSE COMBINATION AND ITS DIFFERENT ANALYTICAL METHOD

Boomiga M.*, Vetrichelvan T., Murugan S.

ABSTRACT

Cefixime trihydrate and potassium clavulanate combination dosage form are widely used for the treatment of bacterial infections caused by susceptible and β-lactamase-producing microorganisms. Cefixime, a third-generation cephalosporin antibiotic, was first approved by the CDSCO in 1993, while clavulanic acid, administered as potassium clavulanate, was approved in combination with β-lactam antibiotics in the early 1980s. The fixed-dose combination of cefixime and potassium clavulanate was subsequently developed to enhance antibacterial efficacy and overcome resistance mediated by β-lactamase enzymes, receiving formal CDSCO approval in 2006. Owing to the extensive clinical use of this combination, reliable analytical methods are required for quality control and routine analysis. A review of the literature indicates that very limited analytical methods have been reported for the simultaneous estimation of cefixime trihydrate and potassium clavulanate in tablet dosage forms. To date, no validated UV spectrophotometric method has been published for this combination, whereas only a few RP-HPLC methods employing phosphate buffer and methanol in different ratios as mobile phases have been reported. Therefore, there is a critical need for the development of simple, economical, accurate, and validated analytical methods for the routine Pharmaceutical analysis of this combination dosage form.

Keywords: Cefixime trihydrate, Potassium clavulanate, Fixed-dose combination, Tablets, RP-HPLC, UV spectrophotometry, Method development, Validation.