DEVELOPMENT AND VALIDATION OF SPECTROPHOTOMETRIC DETERMINATION OF CEFPODOXIME PROXETIL IN PURE AND TABLET DOSAGE FORMS THROUGH ION-PAIR COMPLEX FORMATION USING BROMOTHYMOL BLUE Original Article (original) (raw)
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DRUG ANALYTICAL RESEARCH, 2019
In the present work, analytical methods, UV Spectrophotometry and Liquid Chromatography (HPLC), were developed and validated for quantification of cefpirome, a broad-spectrum fourth-generation cephalosporin, in raw material and powder for injectable preparation. The UV spectrophotometric method was performed at 271 nm, using 0.1 M hydrochloric acid as solvent. The HPLC was carried out using Techsphere ODS column and mobile phase consisted of methanol-water (30:70, v/v) with flow rate 0.8 mL/min and UV detection at 265 nm. The validation method yielded good results demonstrated statistically that the methods were linear, precise, accurate, specific and robust. A preliminary stability study of cefpirome showed that the UV Spectrophotometry and Liquid Chromatography methods were specific for the determination cefpirome in the presence of its degradation products. No statistically difference was observed between the proposed methods. The UV Spectrophotometry and Liquid Chromatography methods allow the quantitation of cefpirome in pharmaceutical dosage form and raw material and can be used for the drug analysis in routine quality control.
Pakistan journal of pharmaceutical sciences, 2017
A new, simple, accurate, precise and specific method has been developed for the analysis of Cefpodoxime Proxetil in human plasma. The proposed method was developed and validated with the aim to be used in Bioavailability/Bioequivalence studies for quantification of drug in human plasma. The mobile phase components were acetonitrile, methanol, and water in the ratio of 20:50:30. Ortho phosphoric acid was used to adjust at pH5.0. Flow rate and wavelength were kept 1ml/min and 247nm respectively. The column was C-18 HPLC column 5um particle size, L x 1.d. 25cm x4.6mm. (Supelcosil). Retention time of Cefpodoxime Proxetil was found to be 10.967min. The developed method was validated for selectivity, recovery, accuracy, precision, repeatability, reproducibility, stability and linearity in the range of 0.195mcg/ml to 50mcg/ml. The accuracy and Precision of the proposed method were well within the predefined limits i.e. ±15% for all the calibration standards other than LLOQ (Lower Limit of ...
Cefpodoxime Proxetil: A New Stability Indicating RP-HPLC Method
ISRN Chromatography, 2013
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 tim...
Pharmaceutical Sciences
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An UVspectrophotometric area under curve method is developed for the estimation of Cefpodoxime Proxetil in its single component tablets. The new method is area under curve method for the analysis of Cefpodoxime Proxetil using methanol as solvent for the drug. Cefpodoxime Proxetil has absorbance maxima at 235nm at area under curve wavelength range of 230nm-240nm. Cefpodoxime Proxetil obeys Beer's law in concentration range 10-50µg/ml. The recovery studies ascertained accuracy of the proposed method; results validated according to ICH guideline. Results were found satisfactory and reproducible. The method was successfully for evaluation of Cefpodoxime Proxetil in tablet dosage form without interference of common excipients.
E-Journal of Chemistry, 2012
A simple, rapid and sensitive spectrophotometric method for the determination of micro amounts of cefepime hydrochloride and cefuroxime sodium is described. The method is based on reduction of 2,3,5-triphenyltetrazolium chloride (TTC) by the cited drugs in slightly alkaline medium leading to formation of a highly colored formazan derivative. Different variables affecting the color development were investigated and optimized. Absorbance measurements were made at 483 nm. Under the proposed conditions, this method is applicable over concentration range of 4–50 µg ml-1with molar absorpitivities ranging from 5.208 x 103–1.217 x 104 L.mol-1.cm-1and Sandell's sensitivities ranging from 1.007 x 10-3–2.727 x10-3µg cm-2. The proposed method was successfully applied for analysis of the cited drugs in formulations and the recovery percentages ranged from 99.47 to 99.8%. The results obtained demonstrated that the proposed method is equally accurate, precise and reproducible as the reported m...
2014
A simple, precise and accurate isocratic stability–indicating RP–HPLC method was developed and validated for the simultaneous determination of Cefpodoxime Proxetil and Dicloxacillin Sodium in commercial tablets. The method has shown adequate separation for Cefpodoxime Proxetil and Dicloxacillin Sodium from their degradation products. Separation was achieved on a Waters C18 (250 mm × 4.6 mm i.d., 5 µm particle size) column using a mobile phase consisting of Acetonitrile – 20 mM Ammonium Acetate Buffer (42:58 v/v) at flow rate of 1 mL/min and UV detection at 235 nm. This drugs were subjected to hydrolysis, oxidation, photolysis and heat to apply stress conditions. The linearity was investigated in the range of 5–25 µg/mL (r 2 = 0.9993) for Cefpodoxime Proxetil and 12.5–62.5 µg/mL (r 2 = 0.9991) for Dicloxacillin Sodium. The LOD were 0.10 µg/mL and 0.68 µg/mL for Cefpodoxime Proxetil and Dicloxacillin Sodium, respectively. The LOQ were 0.33 µg/mL and 2.06 µg/mL for Cefpodoxime Proxetil...
2013
Four different, accurate, sensitive and reproducible stability-indicating methods for the determination of cefpodoxime proxetil (CPD) in the presence of its acid and alkaline degradation products are presented. The first method is based on derivative spectrophotometry. Second derivative spectrophotometry was applied where CPD was determined at 261 nm in the presence of its acid degradation product and also third derivative spectrophotometry was applied where CPD was determined at 282 nm in the presence of its alkaline degradation product. The second method is based on the first derivative of ratio spectrophotometry (1 DD) of CPD at 215 nm and 255 nm in the presence of its acid degradation product and at 243 nm in the presence of its alkaline degradation product. The third method is ratio subtraction spectrophotometry where the drug is determined at 232 nm in laboratory prepared mixtures of CPD and its acid or alkaline degradation product. Calibration graphs were established for 4.0-40.0 μg/ml for CPD determination by the three spectrophotometric methods. The fourth method is an isocratic reversed-phase HPLC procedure, a Zorbax C 8 column was used to separate CPD from its acid and alkaline degradation product using acetonitrile: water: triethylamine (60:40:1, v/v/v) as a mobile phase and detection at 232 nm. The suggested procedures were successfully applied for the analysis of CPD in bulk powder and in pharmaceutical preparations. The results obtained by applying the proposed methods were statistically analyzed and compared with those obtained by the official method.