Cefixime

Cefixime, cefpodoxime and cefepime are cephalosphrin antibiotics used widely in the different infectious diseases. Newer HPTLC methods were developed for their estimation from individual dosage forms due to versatile applications and advantages. The HPTLC chromatogram of cefixime was developed by using a mobile phase ethylene acetate: methanol: water (4.5:5:0.5%v/v) and scanning wavelength was 292nm. The Rf value was 0.58±0.02. The mobile phase optimized for cepodoxime was methanol: ethyl acetate: toluene (1.5:3:5.5% v/v), with the Rf value 0.53±0.02. The cefixime was retained using methanol :water : chloroform (6:3:1%v/v), on a  silica gel G60 F254 aluminium sheet and  scanning wavelength kept at 285nm. The Rf value was 0.44. The methods were optimized validated as per guidelines and successfully applied for individual dosage form containing  of each of cephalosporin.

The Developed RP- HPLC method allows rapid and precise determinations of Cefixime  and Paracetamol. The scope of the present work is to expand and optimization of the chromatographic conditions and to develop RP-HPLC method. A series of mobile phases and columns were tried, among the various mobile phases, Buffer: Acetonitrile (65:35A) (PH-3.5) as an ideal mobile phase, since it gave a good resolution and peak shapes with perfect optimization. The flow rate was optimized at 1 ml/min. The Linearity and correlation coefficient of Cefixime and Paracetamol was found to be 0.999, and 0.999 respectively. Precision was performed and % RSD for Cefixime and Paracetamol were found to be 1.17% and 1.32% respectively. Three concentrations 50%, 100%, 150%, were injected in a triplicate manner and amount recovered and % Recovery was found to be 100%. Limit of detection was calculated by standard deviation method Cefixime and Paracetamol and LOD for Cefixime and Paracetamol were found to be 0.03and 0.02 respectively. Limit of Quantification was calculated by standard deviation method Cefixime and Paracetamol and LOQ for Cefixime and Paracetamol were found to be 0.08 and 0.06 respectively. Small deliberate changes in method like flow rate, mobile phase ratio, and temperature are made but there were no recognized change in the result and are within range as per ICH Guide lines. The average % Assay was calculated and found to be 100.46% and 99.84% for Cefixime and Paracetamol respectively. Hence, the chromatographic method developed for Cefixime and paracetamol is said to be rapid, simple, specific, sensitive, precise, accurate and reliable that can be effectively applied for routine analysis in research institutions, quality control department in Industries, approved testing laboratories, Bio-pharmaceutics and Bio-equivalence studies and in clinical pharmacokinetic studies.

Cefixime has bioavailability of 40-50%, which could be attributed to its low solubility in GI tract. The objective of this pilot study was to compare the efficacy and safety of improved formulation of cefixime 200 mg tablet (CEFOLAC) versus conventional marketed cefixime 200 mg tablet in patients with typhoid fever (TF). Patients with clinical diagnosis of TF were randomized to receive either treatment twice daily for 10 days. Primary efficacy end point was reduction of clinical symptoms score on day 5 and number of patients with absence of clinical symptoms. Secondary endpoints include microbiological cure and clinical relapse on day 10 and 21. Total 22 patients completed study successfully and were subjected to analysis. Percentage improvement in total clinical symptoms score from baseline to day 5 was greater in improved formulation of cefixime (70 %) than conventional cefixime 200 mg tablet (58 %). On day 5, numbers of patients with complete cure of clinical symptoms were greater in group A as compared to group B. All patients in both the groups were cured based on clinical symptoms and microbiological evaluation on day 10 and day 21. No case of clinical relapse was observed. Both the formulations of cefixime were well tolerated by patients. Improved formulation of cefixime offers faster and greater improvement in clinical symptoms than conventional cefixime tablet in patients with TF. Improved formulation of cefixime is a better option for the treatment of patients with TF than conventional cefixime tablet.

Simple area under curve spectrophotometric method for determination of Cefixime and Linezolid in bulk and tablet formulation was developed and validated as per ICH guidelines. The lmax of Cefixime and Linezolid were found to be 289nm and 257nm respectively. The linearity range was found 2-12μg/ mL for Cefixime and 5-30μg/mL for Linezolid. In the tablets dosage form Cefixime and Linezolid were estimated as 99.92% and 99.94% respectively. The lower limit of detection (LOD) for Cefixime and Linezolid was found to be 0.039μg/ml and 1.11μg/ml respectively.and the limit of quantization (LOQ) was determined as the lowest concentration for Cefixime and Linezolid was found to be 0.118μg/mL and 3.37μg/ml respectively. The validated spectrophotometric method employed proved to be simple, economical, precise and accurate.

Accurate, precise, rapid and economical first order derivative spectroscopic method was developed and validated for the estimation of Cefixime and levofloxacin in tablet. The wavelengths selected for quantitation were 289.45 nm for levofloxacin (zero cross for cefixime) and 317.0 nm for cefixime (zero cross for levofloxacin). Linearity for detector response was observed in the concentration range of 2-12 μg/ml for both Cefixime and Levofloxacin using methanol as a solvent with correlation coefficient 0.991 and 0.993 respectively. The proposed method was successfully applied for the simultaneous estimation of both drugs in tablet.

A simple and economical Q-Absorbance spectrophotometric method has been developed for the simultaneous estimation of cefixime and moxifloxacin in their synthetic mixture. The method is based on Q‐absorption Ratio method using two wavelengths, 293.6 nm (λmax of Moxifloxacin) and 276 nm (Isoabsorptive point). Methanol was used as a solvent in the method. Both drugs showed linearity in the range of 4‐14 μg/mL in the methods. The method was validated statistically and recovery studies were carried out. The proposed method was found to be simple, economical, accurate, and reproducible. It can be applied for routine analysis and quality control of both drugs in their combination drug products.