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DEVELOPMENT AND VALIDATION OF SPECTROPHOTOMETRIC METHOD FOR SIMULTANEOUS DETERMINATION OF CEFPODOXIME PROXETIL AND OFLOXACIN IN TABLETS
M. N. Shah et al.
International Journal of Pharmaceutical Sciences and Research , 2012,
Abstract: The present manuscript describes simple, sensitive, rapid, accurate, precise and economical spectrophotometric method for the simultaneous determination of cefpodoxime proxetil and ofloxacin in combined tablet dosage form. The method is based on the simultaneous equations for analysis of both the drugs using methanol as solvent. Cefpodoxime proxetil has absorabance maxima at 236 nm and ofloxacin has absorbance maxima at 299 nm in methanol. The linearity was obtained in the concentration range of 5-29 μg/ ml and 1-13 μg/ml for cefpodoxime proxetil and ofloxacin respectively. The concentrations of the drugs were determined by using simultaneous equations at both the wavelengths. The method was successfully applied to pharmaceutical dosage form because no interference from the tablet excipients was found. The suitability of this method for the quantitative determination of cefpodoxime proxetil and ofloxacin was proved by validation. The proposed method was found to be simple and sensitive for the routine quality control application of cefpodoxime proxetil and ofloxacin in pharmaceutical dosage form. The result of analysis has been validated statistically and by recovery studies.
DEVELOPMENT AND VALIDATION OF DUAL WAVELENGTH UV SPECTROPHOTOMETRIC METHOD FOR SIMULTANEOUS ESTIMATION OF AMBROXOL HYDROCHLORIDE AND CEFPODOXIME PROXETILE IN THEIR COMBINED TABLET DOSAGE FORM  [PDF]
Goswami Jigar,Kakadiya Jagdish,Shah Nehal
International Research Journal of Pharmacy , 2012,
Abstract: The present manuscript describes simple, sensitive, rapid, accurate, precise and economical dual wavelength spectrophotometric method for the simultaneous determination of Ambroxol Hydrochloride and Cefpodoxime Proxetile in combined tablet dosage form. The principle for dual wavelength method is “the absorbance difference between two points on the mixture spectra is directly proportional to the concentration of the component of interest”. The method was based on determination of Cefpodoxime proxetile at the absorbance difference between 230 nm and 251.8 nm and Ambroxol Hydrochloride at the absorbance difference between 250.7 nm and 279 nm. The linearity was obtained in the concentration range of 6-42 μg/ml and 10-70 μg/ml for Ambroxol Hydrochloride and Cefpodoxime Proxetile respectively. The method was successfully applied to pharmaceutical dosage form because no interference from the tablet excipients was found. The suitability of these methods for the quantitative determination of Ambroxol Hydrochloride and Cefpodoxime Proxetile was proved by validation and recovery study. The proposed methods were found to be simple and sensitive for the routine quality control application of Ambroxol Hydrochloride and Cefpodoxime Proxetile in pharmaceutical tablet dosage form.
Formulation and in vitro characterization of cefpodoxime proxetil gastroretentive microballoons
AK Sharma,RK Keservani,SC Dadarwal,Y Choudhary
DARU : Journal of Pharmaceutical Sciences , 2011,
Abstract: Background and the purpose of the study: The objective of the present work was to improve bioavailability of cepodoxime proxetil through gastroretentive microballoon formulation. Methods: Microballoons of cefpodoxime proxetil were formulated by solvent evaporation and diffusion method employing hydroxypropylmethyl cellulose (HPMC) and ethyl cellulose (EC) polymers and characterized for particle size, surface morphology, incorporation efficiency, floating behavior, in vitro drug release study and differential scanning calorimetry (DSC). Results: The average particle size of formulated microballoons was in the range of 54.23±2.78-95.66±2.19μm. Incorporation efficiencies of over 83.77±0.85 % were achieved for the optimized formulations. Most of formulations remained buoyant (having buoyancy percentage maximum of 81.36±1.96%) for more than 12 hrs indicating good floating behavior of microballoons. Higher values of correlation coefficients were obtained with Higuchi's square root of time kinetic treatment heralding diffusion as predominant mechanism of drug release. Conclusion: Inferences drawn from in vitro studies suggest that microballoons may be potential delivery system for cefpodoxime proxetil with improvement in bioavailability in comparison to conventional dosage forms.
COMPARISON OF IN VITRO DISSOLUTION PROFILES OF CEFPODOXIME PROXETIL - PEG SOLID DISPERSIONS WITH CEPODOXIME PROXETIL  [PDF]
Madgulkar Ashwini R,Nimbalkar Umesh A,Dhoka Madhura V,Mirajkar Reshma N
International Journal of Research in Ayurveda and Pharmacy , 2011,
Abstract: The aims of this study were (1) to compare the in vitro dissolution profiles of Solid dispersion of Cefpodoxime Proxetil with PEG 6000, with those of pure drug and physical mixture of Cefpodoxime proxetil and PEG 6000. (2) to apply statistical models to evaluate each ratio of Cefpodoxime proxetil and PEG 6000 in solid dispersion in terms of easy application and usefulness, and (3) to identify the most suitable ratio of Cefpodoxime Proxetil and PEG 6000 as solid dispersion.Solid dispersions of Cefpodoxime Proxetil were prepared with PEG 6000 in different ratios by using kneading method. Dissolution profile of all these solid dispersions were compared with dissolution profile of Cefpodoxime proxetil and physical mixture of Cefpodoxime proxetil and PEG 6000. The results showed that the Solid dispersions containing PEG in different proportions exhibit faster release (about 2.2 – 3 fold faster) than Cefpodoxime proxetil and physical mixture of Cefpodoxime proxetil and PEG. Among the solid dispersions containing different ratios batch A containing Cefpodoxime proxetil and PEG 6000 in 1:1 ratio exhibited about 3 fold improvement in release profile. The release kinetics of Solid dispersions was investigated using several mathematical equations. In Model-independent method similarity factor, f2, was used for the comparison of in vitro dissolution profiles. The results showed that model-dependent methods were more discriminative than model-independent methods. Model independent methods seemed to be easier to apply and interpret; only one value is obtained to describe the closeness of the two dissolution profiles. The application and evaluation of model-dependent methods were more complicated; these methods present an acceptable model approach to the true relationship between percent dissolved and time variables, including statistical assumptions that could be checked.
Development and validation of a HPTLC method for the estimation of cefpodoxime proxetil  [cached]
Darji B,Shah N,Patel A,Patel N
Indian Journal of Pharmaceutical Sciences , 2007,
Abstract: A simple, precise, accurate and rapid high performance thin layer chromatographic method has been developed and validated for the determination of cefpodoxime proxetil in dosage form. The stationary phase used was precoated silica gel 60F254. The mobile phase used was a mixture of chloroform: methanol: toluene (4:2:4 v/v/v). The detection of spot was carried out at 289.0 nm. The method was validated in terms of linearity, accuracy, precision and specificity. The calibration curve was found to be linear between 100 to 700 ng/spot for cefpodoxime proxetil. The limit of detection and the limit of quantification for the cefpodoxime proxetil were found to be 30 ng/spot and 90 ng/spot, respectively. The proposed method can be successfully used to determine the drug content in marketed formulation.
ENHANCEMENT OF SOLUBILITY AND DISSOLUTION RATE OF DRUG CEFPODOXIME PROXETIL
C. Senthilkumar,G. Rameshkumar,S. Subathra,T. Suresh Kumar
International Research Journal of Pharmacy , 2012,
Abstract: The enhancement of oral bioavailability of poorly water-soluble drugs remains one of the most challenging aspects of drug development. Aqueous solubility of any therapeutically active substance is a key property, as it governs dissolution, absorption and thus the in vivo efficacy. The solubility behavior of drug remains one of the most challenging aspects in formulation development. Once if we are able to increase the aqueous solubility of a drug, the disintegration and dissolution properties can be easily altered, as a result, an increase in bioavailability can be easily achieved. This study deals with enhancing the dissolution of poorly soluble Class IV drug Cefpodoxime Proxetil, using different excipients. In order to achieve maximum dissolution, eight different formulations were developed. Optimization has proven as an effective tool in product development. The formulation ARL 8 was found to be optimized product. The different physical properties and in vitro release profile showed better and stable results when compared with marketed product.
DEVELOPMENT AND CHARACTERIZATION OF SOLID DISPERSIONS OF CEFPODOXIME PROXETIL WITH PEG 6000
Nimbalkar Umesh A,Sonawane Prajakta A,Mane Rohit B,Dhoka Madhura V.
International Research Journal of Pharmacy , 2011,
Abstract: Solid dispersion is one of the most successful techniques to improve dissolution rate of poorly aqueous soluble drugs. Cefpodoxime Proxetil, a class IV drug as per BCS is having poor solubility and poor dissolution rate. But when prepared as solid dispersion with hydrophilic carrier showed improved solubility and dissolution rate. So the main purpose of this investigation was to increase the solubility and dissolution rate of Cefpodoxime Proxetil by the preparing its solid dispersion with PEG 6000 using kneading method (KM) method. Physical mixtures and solid dispersions of Cefpodoxime Proxetil were prepared in various proportions (0.5:1, 0.75:1, 1:1, 1:0.5 and 0.75), by employing kneading method. Prepared SDs were optimized from solubility studies and dissolution rate studies. Optimized SD was further characterized for DSC and FTIR studies. From the results it was found that the dissolution rate and the dissolution parameters of the drug from the physical mixture as well as solid dispersion were higher than those of the pure drug. FTIR spectra and DSC data revealed no chemical incompatibility between drug and PEG. Hence, Solid dispersion technology can be used to improve the solubility and dissolution rate of Cefpodoxime proxetil.
Simultaneous RP-HPLC estimation of cefpodoxime proxetil and clavulanic acid in tablets  [cached]
Malathi S,Dubey R,Venkatnarayanan R
Indian Journal of Pharmaceutical Sciences , 2009,
Abstract: A new, simple, precise, rapid and accurate RP-HPLC method has been developed for the simultaneous estimation of cefpodoxime proxetil and clavulanic acid from pharmaceutical dosage forms. The method was carried out on a Zorbax Eclipse XDB 5 μ C 18 (150x4.6 mm) column with a mobile phase consisting of acetonitrile:50 mM potassium dihydrogen phosphate buffer (pH 3.0, 70:30 v/v) at a flow rate of 1.0 ml/min. Detection was carried out at 228 nm. Aspirin was used as an internal standard. The retention time of clavulanic acid, cefpodoxime proxetil and aspirin was 4.43, 6.44 and 5.6 min, respectively. The developed method was validated in terms of accuracy, precision, linearity, limit of detection, limit of quantification and solution stability. The proposed method can be used for the estimation of these drugs in combined dosage forms.
Formulation and Evaluation of Fast Dissolving Tablets (FDTs) of Cefpodoxime Proxetil  [cached]
Atul K. Gupta, Sunny Sharma
Current Trends in Biotechnology and Chemical Research , 2012,
Abstract: The present study was done to formulate fast dissolving tablets of cefpodoxime proxetil for enhanced solubility and dissolution profile. In our study various batches (Cp1-9) were formulated with different ratios of superdisintegrants viz, sodium starch glycolate and microcrystalline cellulose in combination with croscarmellose sodium (1.6%, 3.2%, 4.8%). Aspartame as sweetening agent and flavour was added to increase the patient compliance. Pre-compression parameters including angle of repose, densities, compressibility were evaluated. The prepared tablets were evaluated for hardness, friability, weight variation, disintegration time, in vitro dispersion time and in vitro drug release studies. In our study on the basis of evaluation parameters, batch Cp8 was best formulation. In vitro dissolution studies shows more than 60% of the drug released within 5 minutes.
Cefpodoxime Proxetil: A New Stability Indicating RP-HPLC Method  [PDF]
Ceema Mathew,M. Ajitha,P. R. Sathesh Babu
ISRN Chromatography , 2013, DOI: 10.1155/2013/328157
Abstract: The present work describes the development of a sensitive and economic stability indicating high performance liquid chromatographic (HPLC) method for the determination of cefpodoxime proxetil (CP) as bulk drug and as pharmaceutical formulation. Both R and S isomers of the drug were separated using Phenomenex ( ?mm, 5?μm particle size) ODS column with a flow rate of 1?mL?min?1 and an SPD 20?A UV detector to monitor the eluate at 252?nm. The isocratic method used a mobile phase consisting of methanol and phosphate buffer of pH 4.0 in the ratio 65?:?35. The linear regression analysis data for the calibration plots showed good linear relationship with in the working concentration range of 5–100?μg?mL?1. The LOD and LOQ were 53 and 160?ng?mL?1, respectively. CP was subjected to stress degradation using acid, alkali, hydrogen peroxide, dry heat, wet heat, and UV light. The standard drug peaks were well resolved from the degradation products’ peaks with significantly different retention time (Rt), and the resolution factor for the R and S isomers of CP was found to be greater than 2. 1. Introduction Stability indicating methods are the quantitative analytical methods that are based on the characteristic structural, chemical, or biological properties of each active ingredient of a drug product and that will distinguish each active ingredient from its degradation products so that the active ingredient content can be accurately measured [1]. The International Conference on Harmonization (ICH) guideline entitled “Stability Testing of New Drug Substances and Products” requires that stress testing be carried out to elucidate the inherent stability characteristics of the active substance [2]. Acidic, alkaline, oxidative, and photolytic stabilities are required. An ideal stability indicating method is the one that quantifies the standard drug alone and also resolves it from its degradation products [3]. Stability indicating method is an analytical procedure that is capable of discriminating between the major active pharmaceutical ingredient (API) and any degradation (decomposition) product(s) formed under defined storage conditions during the stability evaluation period [4]. Cefpodoxime proxetil (CP) is a prodrug that is deesterified in vivo to its active metabolite, cefpodoxime, to exhibit antibiotic activity [5–9]. The structure of CP is given in Figure 1. It is active against most Gram positive and Gram negative organisms. It is commonly used in the treatment of a variety of infections of skin, respiratory tract, urinary tract, and systemic infections and also to
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