Eurasian J. Anal. Chem. 5(3): 227-238, 2010 Application of HPLC and HPTLC for the Simultaneous Determination of Cefixime Trihydrate and Ambroxol Hydrochloride in Pharmaceutical Dosage Form Mahesh M. Deshpande a , Veena S. Kasture b* , Seema A.Gosavi b a Department of Pharmaceutical chemistry, MGV’S College of Pharmacy, Panchvati, Nashik-03, b Sanjivani College of Pharmaceutical Education and Research, Kopargaon, Dist: Ahmednagar, (M. S.), India, 423603. Received: 13 August 2009; Accepted: 17 Februray 2010 Abstract Two sensitive and reproducible methods are described for the quantitative determination for the simultaneous estimation of cefixime trihydrate and ambroxol hydrochloride. The first method was based on HPTLC followed by densitometric measurements of their spots at 254 nm. The separation was on HPTLC aluminium sheets of silica gel 60 F254 using acetonitrile: methanol: triethylamine (8.2:1:0.8, v/v/v) as mobile phase. The linear regression analysis was used for the regression line in the range of 200 - 1000 ng spot -1 for cefixime and ambroxol, respectively. This system was found to give compact spots for cefixime and ambroxol, after development. The second method was based on HPLC separation of the two drugs on the column [C18 (5 μ, 25 cm×4.6 mm, i.d.)] at ambient temperature using a mobile phase consisting of acetonitrile: methanol (50:50, v/v). Quantitation was achieved with UV detection at 254 nm based on peak area with linear calibration curves at concentration ranges 4 - 18 and 4 - 28 μg mL -1 for cefixime and ambroxol, respectively. Both methods have been successively applied to pharmaceutical formulation. No chromatographic interference from the tablet excipients was found. Both methods were validated in terms of precision, robustness, recovery and limits of detection and quantitation. Keywords: Cefixime; ambroxol; HPTLC; HPLC; method validation 1. Introduction Cefixime (CFX) ((6R, 7R)-7-[(Z)-2-(2-amino-4-thiazolyl)-2-(carboxy-methoxyimino) acetamido]-8-oxo-3-vinyl-5-thia-1-azabicyclo-[4,2,0]-oct-2-ene-2-carboxylic acid), is an orally absorbed third generation cephalosporin antibiotic. It has a broad antibacterial spectrum against various gram-positive bacteria and gram-negative bacteria, including Haemophilus influenzae, Neisseria gonorrhoeae, Escherichia coli, and Klebsiella pneumoniae resistant to ampicillin, cephalexin, cefaclor, and trimethoprim- sulfamethoxazole. Ambroxol, (AMB) trans-4-(2-amino-3, 5-dibromobenzylamino) cyclohexanol hydrochloride is a compound with potent mucolytic activity, for which it is used as an expectorant and bronchosecretolytic in therapeutics [1-5]. The structures of drugs are shown in (Fig.1). Literature survey revealed many chromatographic methods for determination of Cefixime alone or in combinations with other drugs from pharmaceutical formulations and biological fluids [6-10]. Several chromatographic methods have also been reported for determination of Ambroxol from * Corresponding Author E-mail: veenakasture@hotmail.com ISSN: 1306-3057, Moment Publication ©2010