Int J Chromatogr Sep Tech, an open access journal ISSN: 2577-218X 1 Volume 2018; Issue 01 International Journal of Chromatography and Separation Techniques Research Article Rao AL, et al. Int J Chromatogr Sep Tech: IJCST-117. Validated Stability Indicating RP-HPLC Method for Simultaneous Deter- mination of Cefxime and Acetylcysteine in Pharmaceutical Dosage Form A. Lakshmana Rao * , T. Prasanthi, V. Aswini Department of Pharmaceutical Analysis, VV Institute of Pharmaceutical Sciences, Gudlavalleru, Andhra Pradesh, India * Corresponding author: A. Lakshmana Rao, Department of Pharmaceutical Analysis, VV Institute of Pharmaceutical Sciences, Gudlavalleru, Andhra Pradesh 521356, India. Tel: +919848779133; +918674274649; Email: dralrao@gmail.com Citation: Rao AL, Prasanthi T, Aswini V (2018) Validated Stability Indicating RP-HPLC Method for Simultaneous Determination of Cefxime and Acetylcysteine in Pharmaceutical Dosage Form. Int J Chromatogr Sep Tech: IJCST-117. DOI: 10.29011/2577-218X. 000017 Received Date: 01 July, 2018; Accepted Date: 30 July, 2018; Published Date: 03 August, 2018 DOI: 10.29011/2577-218X. 000017 Abstract A simple stability indicating RP-HPLC method has been developed for the simultaneous determination of Cefxime in combination with Acetylcysteine using ODS C18 column (250 × 4.6 mm, 5 μm) with UV detection at 274 nm. The mobile phase consisting of 0.1% Ortho Phosphoric Acid (OPA) and acetonitrile in a ratio of 58:42, v/v and at a fow rate of 1.0 mL/min. The method was linear over the concentration range for Cefxime 50-375 μg/mL and for Acetylcysteine 75-400 μg/mL. The retention times for Cefxime and Acetylcysteine were found to be 2.018 and 5.141 min respectively. The average percentage recoveries of Active Pharmaceutical Ingredient (API) Cefxime and Acetylcysteine were found to be in the range of 99.23% and 100.13% respectively. %RSD of the Cefxime and Acetylcysteine were found to be 0.9 and 0.8 respectively. %Assay obtained as 99.23% and 100.13% for Cefxime and Acetylcysteine respectively. The method was validated and was successfully employed for the routine quantitative analysis of pharmaceutical formulations containing Cefxime and Acetylcysteine in combined tablet dosage form. Keywords: Acetylcysteine; Cefxime; HPLC; Validation Introduction Cefxime (Figure 1), an antibiotic, is a third-generation oral bactericidal cephalosporin. Cefxime is chemically known as (6R,7R)-7-[(2Z)-2-(2-amino-1,3-thiazol-4-yl)-2- [(carboxymethoxy) imino]acetamido]-3-ethenyl-8-oxo-5-thia-1- azabicyclooct-2-ene-2-carboxylic acid [1]. The antibacterial effect of Cefxime results from inhibition of mucopeptide synthesis in the bacterial cell wall. Cefxime is extremely stable in presence of β-lactamase enzymes. Cefxime is used in the treatment of uncomplicated urinary tract infections caused by Escherichia coli and Proteus mirabilis, otitis media caused by Haemophilus infuenzae, pharyngitis and tonsillitis caused by S. pyogenes and uncomplicated gonorrhea (cervical/urethral) caused by Neisseria gonorrhoeae etc. Figure 1: Structure of Cefxime. Acetylcysteine (Figure 2), is primarily used as a mucolytic agent and in the management of acetaminophen poisoning. It is chemically known as (2R)-2-acetamido-3-sulfanylpropanoic acid [2]. It is a derivative of cysteine with an acetyl group attached to the amino group of cysteine. NAC is essentially a prodrug that is converted to cysteine (in the intestine by the enzyme aminoacylase 1) and absorbed in the intestine into the blood stream. Acetylcysteine