SIMULTANEOUS ESTIMATION OF AZITHROMYCIN DIHYDRATE AND CEFIXIME TRIHYDRATE IN PHARMACEUTICAL FORMULATION BY HPTLC METHOD

• Published in: Journal of liquid chromatography & related technologies 2014-08, Vol.37 (13), p.1805-1818
• Main Authors: Raval, Priyanka L., Mehta, Falgun A., Ahir, Keyur B., Bhatt, Kashyap K.
• Format: Article
• Language: English
• Subjects: azithromycin dihydrate; cefixime trihydrate; Chromatography; densitometry; HPTLC; Methods; Pharmaceuticals; tablets; validation
• ISSN: 1082-6076; 1520-572X
• DOI: 10.1080/10826076.2012.706859

□ New, simple, accurate, and precise high-performance thin-layer chromatographic (HPTLC) methods are described for simultaneous analysis of azithromycin dihydrate and cefixime trihydrate in pharmaceutical formulations by three methods: (1) UV method, (2) stannic chloride, and (3) ethanolic sulfuric acid. The separations were achieved on prepared HPTLC plates precoated silica gel G 60 F 254 and the plates were developed with methanol-ethyl acetate-toluene-ammonia (30%) 4.5:3.5:2:0.4%v/v/v/v as mobile phase. Detection and evaluation of chromatograms was performed densitometrically at 215nm for UV detection and 450nm for derivatized methods. The R f of azithromycin dihydrate and cefixime trihydrate was 0.8 and 0.27, respectively, in Method 1 and 2, and 0.67 and 0.3, respectively, for Method 3. The linear range was 1000-5000, 1500-5000, and 1000-6000ng/spot per spot for azithromycin dihydrate for Method 1, 2, and 3, respectively, and 400-2000, 1600-4000, and 400-2400ng/spot for cefixime trihydrate Method 1, 2, and 3, respectively; the correlation coefficients r were 0.9971, 0.9944, and 0.9969 for azithromycin and 0.9882, 0.9993, and 0.9991 for three methods, respectively. The methods were validated for linearity and range, specificity, precision, accuracy, and robustness. The methods were applied to the analysis of drugs in its tablet dosage form.