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Cefuroxime axetil (CFA) is the oral prodrug formulation of the injectable antibiotic cefuroxime sodium. It is the second generation cephalosporin with both an intravenous and oral formulation. CFA is the 1-acetoxyethyl ester of cefuroxime. A rapid and reproducible High Performance Liquid Chromatographic method has been developed for the estimation...
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... proteins, termed the penicillin-binding proteins, which are located in the bacterial cell wall. Inhibition of these proteins leads to bacterial cell wall elongation and leakage, thus the bacteria are unable to divide and mature [3]. Cefuroxime is excreted by glomerular filtration and tubular secretion [4]. Chemical structure of CFA is shown in Fig. 1. In the present study the techniques were used for the determination of CFA are reported to include thin layer chromatography [5], High performance liquid chromatography (HPLC) [6, 7 and 8] infra-red spectrum and UV Spectrophotometry [9]. To develop a rapid, sensitive and validated HPLC method for the estimation of cefuroxime axetil. ...
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... axetil (CFA), (1 RS )-1-[(acetyl)oxy]ethyl (6 R ,7 R )-3-[(amino carbonyloxy) methyl]- 7-[[( Z )-2-(furan-2-yl)-2-(methoxyimino)acetyl]amino]-8-oxo-5-thia-1-azabicyclo [4.2.0] oct-2-en-2-carboxylate, is an orally absorbed pro-drug of cefuroxime that is used in the treatment of common community acquired infections because of its in vitro antibacterial activity against several Gram-positive and Gram-negative organisms [1]. It is highly effective against many of the common respiratory pathogens including Streptococcus pneumoniae, Haemophilus influenzae, and Moraxdla catarrhalis . It is one of the few oral cephalosporins with some activity against isolates of S. pneumoniae that are intermediately resistant to penicillin [2]. Cefuroxime axetil is a second- generation cephalosporin that contains the classic β -1actam ring structure. Bactericidal activity in vivo is resultant of its binding to essential target proteins, termed the penicillin-binding proteins, which are located in the bacterial cell wall. Inhibition of these proteins leads to bacterial cell wall elongation and leakage, thus the bacteria are unable to divide and mature [3]. Cefuroxime is excreted by glomerular filtration and tubular secretion [4]. Chemical structure of CFA is shown in Fig. 1. In the present study the techniques were used for the determination of CFA are reported to include thin layer chromatography [5], High performance liquid chromatography (HPLC) [6, 7 and 8] infra-red spectrum and UV Spectrophotometry [9]. To develop a rapid, sensitive and validated HPLC method for the estimation of cefuroxime axetil. The method was validated and selectivity, limits of detection and quantification, linearity, precision and assay were determined. Validation process was mainly based on the ICH guideline [12]. To shorten the period of development, the chemical stability of Ceroxim® tablets was evaluated in accelerated storage conditions at high temperature and high relative humidity (RH) by high- performance liquid chromatographic method. The applicability of this method in determining the drug in commercial dosage forms was also studied. A HPLC system with (LCIDAT VP pumps with gradient mixer assembly, spd – 10A VP UV visible Spectrophotometric detector, SIL10ADVP auto injector and SCL-10A vp system controller [SHIMADZU – VP series]. Data handling system [Class vp software of Shimadzu, version 6.12 or equivalent], Analytical Column : A stainless steel column-18 150mm long , 4.6mm internal diameter filled with octyl silane chemically bonded to porous silica particles of 5 m diameter. Isocratic single pump was employed in the study. HPLC grade methanol and potassium dihydrogen phosphate A.R grade, water for HPLC was prepared from MINI-Q grade were used for preparing the mobile phase. Cefuroxime axetil from Aurobindo labs Hyderabad, India. Dissolve 4.0g of potassium dihydrogen orthophosphate in 100ml of water. Adjust to pH of the buffer to 2.0 0.05 with orthophosphate acid. Filter through 0.45 or fine porosity filter membrane filter. Weigh about 5gm of Cefuroxime axetil reference samples into a 2.5ml of clean dry volumetric flask, add 5ml of acetonitrile and sonicate to dissolve. Make up to volume with water. Filter through 0.45 or finer porosity membrane filter, to the given reaction sample [ 0.5ml add 10ml of acetonitrile and sonicate. filtration 0.45 or finer porosity membrane filter] Inject 20 l of system suitability solution before and after deanalysis into the chromatograph and record the chromatograms. The column efficiency as determined from Cefuroxime axetil peak is not less than 4000 theoretical plates and asymmetry for the same peak is not more than 2.0. Separately inject 20 l of diluent sample solution into the chromatograph and record the chromatograms. Examine the diluent chromatograms for any extraneous peaks and disregard. Corresponding peaks observed in the chromatograms of the sample solution, disregard any peak less than 0.05% area in the chromatogram of the sample solution. The commercially available Cefuroxime axetil lyophilized injection of 4mg in 5ml strength of AUROBINDO DRUGS was chosen for this purpose. Take all the 5 vials containing Cefuroxime axetil parenteral preparations in each vial 4 mg in 5 ml was reconstituted with water for injection. Transfer them into a 25 ml volumetric flask mix thoroughly. It is diluted with mobile phase to get the concentration of 10μg/mL. High performance liquid chromatography (HPLC), infra red spectrum and UV Spectrophotometry. To develop a rapid, sensitive and validated HPLC method for the estimation of cefuroxime axetil. The present study was carried out to develop a sensitive, precise and accurate HPLC method for the analysis of Cefuroxime axetil in pharmaceutical dosage forms. In order to affect analysis of the component peaks under isocratic conditions, mixtures of methanol and 0.01M potassium dihydrogen orthophosphate buffer in different combinations were tested as mobile phase on a C-18 stationary phase. A binary mixture of Methanol and 0.01M potassium dihydrogen orthophosphate buffer in 60:40v/v proportion was proved to be the most suitable of all combinations since the chromatographic peaks were better defined and resolved and almost free from tailing. The retention times obtained for Cefuroxime axetil acid was 3.693. A model chromatogram is shown in Figure 2. The system suitability parameters including retention time, area, height, area (%) are shown in Table 1. The method was validated with respect to linearity, accuracy and precision for the Cefuroxime axetil, as summarized here. The linearity was evaluated and established by triplicate injection of the working standard solutions of Cefuroxime axetil. The peak areas were measured and the ratios the peak areas of cefuroxime axetil to that of the internal standard were calculated for each injection. The linear regression was computed by the least square method using Microsoft Excel program to determine the slopes and correlation coefficients for the calibration graphs between the peak area ratios of compounds to internal standard were plotted against the compound concentration to generate calibration curves. Reported statistical data showed that calibration curves generated linear results over the investigated concentration range: for Cefuroxime axetil from 0.100 to 1.000 mg ml−1 (y = 28.49x + 0.509; R 2 = 0.986), where y is peak area ratio, x is concentration of the compound and R is the correlation coefficient. When Cefuroxime axetil solutions containing 4 to 10 μg /mL was analyzed by the Cefuroxime axetil for finding out intra and inter-day variations as low coefficient of variation was observed as shown in Table 2. This shows that the present HPLC method is highly precise. The amounts of Cefuroxime axetil obtained from the pre-analyzed samples containing known amounts of added drug are shown in Table 3. About 99.66% of Cefuroxime axetil could be recovered from the pre-analyzed samples indicating the high accuracy of the Cefuroxime axetil. Limits of detection (LOD) were estimated by analyzing serial dilution of working standards of the compounds, corresponding to the concentration at the lower end of each of the calibration curves (assayed in triplicate). Limits of quantification (LOQ) were determined experimentally, by injecting the decreasing concentrations of investigated calibration solutions to obtain the lowest reproducible measurement of peak areas. Reported values are shown in Table 4 . The HPLC method developed for quantitative determination of Cefuroxime axetil is precise, accurate, and selective. The method was completely validated and satisfactory results were obtained for all the method validation data tested. I would like express my gratitude to all those who gave me the possibility to complete this project work. I want to thank the Department of QC of the Aurobindo Pharma pvt Limited Hyderabad for giving me permission to commence and to do necessary research ...
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Objective Cefuroxime axetil is a second generation cephalosporin antibiotic active against wide range of organisms, which is a prodrug of Cefuroxime. Cefuroxime axetil is extremely bitter in taste, which reduces the patient compliance when taken as oral suspension especially in pediatric population. The objective of this study was to mask the bitte...
Cefuroxime axetil is a prodrug of Cefuroxime, which is a second generation cephalosporin antibiotic with activity against wide range of organisms. Cefuroxime axetil is extremely bitter in taste, which reduces the patient compliance when taken as oral suspension especially in pediatric population. Also the bioavailability of oral suspension is only...
Cefuroxime axetil is a second generation cephalosporin antibiotic with activity against wide range of organisms. It is a prodrug that gets converted into Cefuroxime after oral absorption. Cefuroxime axetil is a poorly water soluble drug, thus it has got only limited solubility and dissolution rate in gastric fluids. Also the bioavailability of Cefu...
Citations
... Various spectrophotometric [5][6][7][8][9][10][11][12][13][14][15][16][17][18][19][20][21][22], High Performance Liquid Chromatographic (HPLC), Reversed-phase high performance liquid chromatography (RP-HPLC), high performance thin layer chromatographic (HPTLC), micellar liquid chromatographic (MLC) [23][24][25][26][27][28][29][30][31][32][33][34][35][36][37] and voltammetric [38,39] methods have been reported for the determination of cefuroxime. ...
... The method produced linear responses in the concentration range of 0.45 to 80 µg.mL -1 of CRXA. The method was successfully validated in accordance to The International Conference on Harmonization (ICH) guidelines and was found to be reproducible for analysis of the drug in parental preparations [27]. ...
... μg.mL -1 ) , with relative standard deviation (RSD) not more than 4.2%. The results obtained from the developed method have been compared with the official HPLC method [27] and good agreement was observed between them. Table 2: Spectrophotometric determination of CRXA through complex formation with BTB within optimal conditions using calibration curve in chloroform (n=5, t=2.776). ...
A simple, direct and cost-effective spectrophotometric method for determination of cefuroxime axetil (CRXA) in pure and tablet dosage forms was applied. This method is based on formation of ion-pair complex ([CRXA]:[BTB]) between CRXA and bromothymol blue (BTB) in chloroform. Beer’s law in the optimum experimental conditions using [CRXA]:[BTB] complex is valid within a concentration range of 2.00-50.00 ?M (1.021–25.524 ?g.mL-1). The developed method is applied for the determination of CRXA in pure and its commercial tablets without any interference from excipients with average assay of 96.8 to 101.6% and the results are in good agreement with those obtained by the HPLC reference method. Associated drugs (sulbactam and linesolid) with cefuroxime axetil are considered to be interfere, while metronidazole can be considered as non-interfere.
... -2-oxo-1,3-oxozolidin-5yl] methyl] acetamide}( Figure 2) 7 . The deep literature survey reveals that various spectrophotometric and chromatographic methods [8][9][10][11][12][13][14][15][16][17][18][19][20][21][22] available for the estimation of CEF and LZD alone and in combination with other drugs and in biological fluids. Combination of cefuroxime axetil and linezolid is not official in any pharmacopoeias and hence no official method available for analysis of both drugs in combination. ...
Three simple, accurate, sensitive, precise and economical UV spectrophotometric methods (A, B & C) have been developed for simultaneous estimation of cefuroxime axetil and linezolid in pharmaceutical dosage form and their comparision using ANOVA. Method A employs solving of simultaneous equations based on the measurement of absorbance at two wavelengths, 277 nm and 257 nm which are the λmax values of cefuroxime axetil and linezolid, respectively in methanol. Method B is based on the principle of Q- absorbance ratio where in the absorbance was measured at 272 nm (iso-absorptive point) and 257 nm (λmax of linezolid) in methanol. The linearity was obtained in the concentration ranges of 3-11 and 3.6 – 13.2 µg/ml, respectively. Method C is based on the first derivative spectrophotometric method at zero crossing wavelengths. In this method the zero crossing point of cefuroxime axetil was selected at 256 nm and for linezolid it was 275 nm. The linearity was obtained in the concentration range of 10-30 μg/ml for cefuroxime axetil and 12-36 μg/ml for linezolid. The accuracy and precision of the methods were determined and validated statistically. All the methods showed good reproducibility and recovery with % RSD less than 2. The three methods were compared using one -way ANOVA and the fcal value was found to be less than ftab value indicating that there is no significant difference in the assay results by the three methods. All methods were found to be rapid, specific, precise and accurate and these methods require no preliminary separation and found no interferences from the tablet excipients so it can be used for routine analysis of both drugs in quality control laboratories. © 2016, International Journal of Pharmaceutical Quality Assurance. All rights reserved.
Background:
Textile materials are susceptible to microbial attack as they provide suitable conditions for their growth. The microbes grow with normal body secretions on garments. These microbes are responsible for the weakening, brittleness, and discoloration of the substrate. Furthermore, they cause many health issues to the wearer, including dermal infection, bad odour etc. They threaten the human health as well as create tenderness in fabric.
Objectives:
Usually, antimicrobial textiles are prepared by applying antimicrobial finishes after dyeing, which is an expensive approach. Concerning these adversities, in the present study, a series of antimicrobial acid-azo dyes have been synthesized by incorporating antimicrobial sulphonamide moiety into the dye molecules during its synthesis.
Methods:
A commercially available sulphonamide-based compound, sulfadimidine Na-salt was used as a diazonium component and coupled with different aromatic amines to get desired dye molecules. Since dyeing and finishing are two separate energy-intensive processes, in the current research work, an approach to combine both processes in one step has been adopted that would be economical, time-saving, and environment friendly. Structures of the resultant dye molecules have been confirmed using different spectral techniques such as Mass spectrometry, 1H-NMR spectroscopy, FT-IR, and UV-Visible spectroscopy.
Results:
Thermal stability of the synthesized dyes was also determined. These dyes have been applied to wool and nylon-6 fabrics. Their various fastness properties were examined using ISO standard methods.
Conclusion:
All the compounds exhibited good to excellent fastness properties. The synthesized dyes and the dyed fabrics were screened biologically against Staphylococcus aureus ATCC 6538 and Escherichia coli ATCC 10536, resulting in significant antibacterial activities.
Two novel, economic, rapid, simple, sensitive and selective square wave voltammetric (SWV) methods have been developed for the determination of cefuroxime axetil (CEFA) in pharmaceutical preparations. Electrochemical reduction and oxidation of the substance on hanging mercury drop electrode and graphene oxide modified glassy carbon electrode were investigated by square wave voltammetric methods which employ scan rates up to 1000 mV/s or faster, allowing much faster determinations. For hanging mercury drop electrode, well-defined peak was obtained at –1.06 V vs. Ag/AgCl/4.6 M KCl in 0.1 M phosphateborate buffer pH 7.0, limit of detection (LOD), limit of quantification (LOQ) and linearity range were found 0.09, 0.26, and 0.26–15 μg mL–1, respectively. For modified glassy carbon electrode, well-defined peak was obtained at 1.30 V vs. Ag/AgCl/4.6 M KCl in Britton–Robinson buffer pH 2.0, LOD, LOQ and linearity range were found 2.70, 8.20, and 8.20–45 μg mL–1, respectively. According to validation studies, the developed SWV methods were found as accurate, precise, specific, sensitive, repeatable, rugged and robust. The developed and validated SWV methods were applied to the determination of CEFA in pharmaceutical formulations. The results were compared with those obtained by a published ultraviolet spectroscopic method and no difference was found statistically.
A simple, rapid and sensitive spectrophotometric method has been developed for simultaneous estimation of cefuroxime axetil and potassium clavulanate in combined dosage form. Maximum absorbance of cefuroxime axetil and potassium clavulanate was measured in methanol at 284 nm and 271nm. The calibration curve of both the drug bey's the Beer's Law in the concentration range 5-50μg/ml for cefuroxime axetil and 1-30μg/ml for potassium clavulanate with correlation coefficient value 0.999 and 0.998 at 284nm and 271nm respectively. The present method was validated as per ICH guidelines. The result obtained of this method were in good agreement recommended for routine analysis where time, cost effectiveness and high specificity of analytical techniques are of great importance.
Objective: To develop a new validated simple, precise, specific and accurate reverse phase High Pressure Liquid Chromatographic method for the simultaneous determination of Cefuroxime axetil (CA) and Potassium clavulanate (PC) in tablet dosage form. Method: Chromatographic separation was achieved on reverse phase Microsorb-MV 100-5 C-18 (250x4.6mm, 5 μm) column with a mobile phase consisting of HPLC grade methanol:water in the ratio of 90:10 (v/v) at a flow rate of 1.0 mL/min with UV detection at 230 nm. Result: The retention time for Cefuroxime axetil and Potassium clavulanate were 2.46 & 3.33 min. respectively. The method was validated according to the ICH guidelines with respect to specificity, linearity, accuracy, precision and robustness. The regression value for both the drugs was found to be 0.996 and 0.992, the S.D. & R.S.D. values were found to be well within the acceptable limit of 2.0%. Conclusion: Proposed HPLC method is specific, accurate and precise for the simultaneous determination of Cefuroxime axetil and Potassium clavulanate from pharmaceutical dosage form. The described method is suitable for routine analysis and quality control of pharmaceutical preparations containing these drugs either as such or in combination.
