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Development and Validation of the Quantitative Analysis of Ceftazidime in Powder for Injection by Infrared Spectroscopy#
Physical Chemistry , 2012, DOI: 10.5923/j.pc.20120201.02
Abstract: Ceftazidime quantification by the infrared spectroscopy was developed and validated for pharmaceutical preparations in powder for injection. This method involved absorbance measurements of the band corresponding to aromatic ring centered by 1475-1600 cm-1. Selectivity, linearity, precision and accuracy were determined in order to validate the proposed method. It was also found that the excipient did not interfere with the assay. Calibration curve was obtained for ceftazidime at 0.5 to 7.0 mg, and mean recovery percentage was 98.98 ± 0.70. The proposed method was successfully applied to the assay of ceftazidime in powder for injection.
METHOD DEVELOPMENT AND VALIDATION FOR THIRD GENERATION CEPHALOSPORIN BY UV-VIS SPECROPHOTOMETER
Devkhile A. B,Shaikh K. A
International Research Journal of Pharmacy , 2011,
Abstract: The present study describes a simple, accurate, precise and cost effective UV-Vis Spectrophotometric method for the estimation of ceftazidime, a third generation cephalosporin anti‐biotic in dry powder injection and drug substances. The solvent used throughout the experiment was distilled water. The λmax or the absorption maxima of the drug was found at 275 nm. Beer’s law was obeyed in the range of 2.0-16.0 μg/ml. The developed method was successfully validated with respect to linearity, accuracy and precision. The sample concentrations are measured on weight basis throughout the experiment. The method was validated and shown linear in the mentioned concentrations. The correlation coefficient for ceftazidime was 0.9999. The recovery values for ceftazidime ranged from 99.9-100.3. The relative standard deviation of six replicates of assay was less than 2 %. The percent relative standard deviation of inter-day precision ranged 1.1-1.4 % and intra-day precision 1.2-1.6 % of ceftazidime. The limit of detection and limit of quantification of ceftazidime was 0.12 μg/ml and 0.46 μg/ml. The developed method was cross checked with high performance liquid chromatography for six replicate assays, the mean assay was 100.1% and %RSD was 0.35%.Hence proposed method was precise, accurate and cost effective. This method can be applicable for quantitative determination of the titled drug with respect to assay from their new commercial formulation of injection in quality control laboratories.
Stability Study and Degradation Kinetics of Ceftazidime in Pharmaceutical Preparations
Advances in Analytical Chemistry , 2012, DOI: 10.5923/j.aac.20120201.01
Abstract: Stability study of ceftazidime was realized in order to investigate kinetics of degradation of this drug both in powder for injection and reconstituted sample. Ceftazidime was submitted to conditions of accelerated thermal degradation and photodegradation. Analyses of the degraded samples were performed by microbiological assay and decomposition reactions could be described by zero-order and second-order kinetics. Results obtained confirm the reliability of the microbiological assay for determination of ceftazidime by the presence of its degradation products. The present study revealed thermal and photo lability of the drug, especially as reconstituted sample, and protection is recommended during storage and handling.
Validated Spectrophotometric Estimation of Famcoclovir in Tablet Dosage Form.  [PDF]
Dr.B.Anil Reddy,A.Srikar.
Journal of Pharmaceutical Science and Technology , 2009,
Abstract: A simple and sensitive spectrophotometric method has been developed for the estimation of Famciclovir in bulk and tablet dosage form. This was based on the condensation reaction of Famciclovir with carbonyl reagent such as p-dimethylaminocinnamaldehyde (PDCA) in acidic condition to form orange red colored chromogen with absorption maxima at 510 nm. Beer’s law is obeyed in the concentration range of 2-10 mcg/ml. The developed method was validated for precision, accuracy, ruggedness and robustness. Statistical analysis proves that the method is reproducible and selective for the routine analysis of said drug.
Spectrophotometric estimation of Betaxolol Hydrochloride in bulk powder and its dosage forms  [cached]
Suhagia B,Shah S,Rathod I,Patel H
Indian Journal of Pharmaceutical Sciences , 2006,
Abstract: A simple and sensitive spectrophotometric method has been developed for determination of betaxolol hydrochloride in bulk powder, and its pharmaceutical dosage forms. In the proposed method, betaxolol is oxidized with sodium periodate, to liberate formaldehyde, which is determined in situ, using acetyl acetone in the presence of ammonium acetate. A yellow coloured chromogen was obtained having absorption maxima at 405 nm. The method is found to be linear in the concentration range of 5-30 μg/ml, with a regression co-efficient of 0.9997. No significant difference was found between the proposed method and official method, when one tailed and two tailed t-test are applied. Various reaction parameters such as concentration of sodium hydroxide and sodium periodate, time required for oxidation, reagent concentration, and time for maximum colour intensity were optimized. The method was validated, and can be used successfully to assay betaxolol in bulk powder, and its pharmaceutical dosage forms viz. ophthalmic solutions.
Determination of tacrolimus in pharmaceutical formulations by validated spectrophotometric methods
T. M. B?ER,M. R. MARQUES,S. G. CARDOSO
Revista de Ciências Farmacêuticas Básica e Aplicada , 2009,
Abstract: Two simple, rapid and sensitive spectrophotometric methods were developed for the determination of tacrolimus in pharmaceutical dosage forms. The methods, based on the sulphuric acid reaction and on the iodine charge-transfer reaction, gave absorption peaks at 295 nm and 365 nm, respectively. The calibration curves were linear in the concentration range of 30-55 μg mL-1for the sulphuric acid method (r2=0.9999) and 5-10 μg mL-1 (r2=0.9999) for the charge-transfer method. The specificity was assessed, showing that there was no interference from the excipients. The accuracy of both of the methods was higher than 99.44%, with a bias lower than 2%, and high precision was also demonstrated. The limits of quantitation for the two methods were 30 μg mL-1 and 5 μg mL-1. The proposed methods were applied to the determination of tacrolimus in capsule dosage forms, and the results compared statistically with the validated reversed-phase liquid chromatography (RP-LC) method, showing significant correlation (p<0.05) and demonstrating either method to be an excellent alternative to LC. The application of these simple methods to routine quality control analysis of pharmaceuticals could contribute to their safety and therapeutic efficacy. Keywords: tacrolimus; sulphuric acid reaction; iodine charge-transfer; spectrophotometry; pharmaceutical formulations.
Dry Powder Inhalers - An Overview
M. Alagusundaram,N. Deepthi,S. Ramkanth,S. Angalaparameswari
International Journal of Research in Pharmaceutical Sciences , 2010,
Abstract: The drug product encompasses the pharmacologic activity with the pharmaceutical properties. The ideal characte-ristics are physical and chemical stability, ease of processing, accurate and reproducible delivery to the target or-gans and availability at the site of action. A Dry powder inhaler (DPI) is a device that delivers medication to the lungs in the form of a dry powder. For the DPI, these goals can be met with a suitable powder formulation, an efficient metering system and a perfectly selected device. This review focuses on the dry powder inhaler formulation, evaluation, material methods and development processes. Most of the dry powder inhaler formulation en-compasses micronized drug particles blended with larger carrier particles that promote the flow properties, re-duce aggregation and help in dispersion. A combination of the physicochemical properties, particle size, shape, surface area and morphology affects the forces of interaction and aerodynamic properties, which in turn deter-mine the fluidization, dispersion, delivery to the lungs and deposition in the peripheral airways. However the properties of free micronized powders often interfere with the drug handling and with drug delivery, reducing the dose consistency. Dry powder inhalers are evaluated by the drug product characterization studies such as the in vitro dose proportionality, effect of patient dose, priming etc. The development of the new designs of the DPI is governed by the driving forces such as the regulatory and pharmacopoeial requirements, delivery systems for the NCE, clinical factors and commercial factors.
VALIDATED SPECTROPHOTOMETRIC METHODS FOR THE DETERMINATION OF CARVEDILOL IN TABLETS  [PDF]
Patel Satish A,Patel Natavarlal J.
International Research Journal of Pharmacy , 2011,
Abstract: Three simple, sensitive, precise and economical UV- spectrophotometric methods have been developed for the determination of Carvedilol in tablet formulation. Method A is simple UV spectrophotometric method and is based on determination of carvedilol in 0.1 N HCl at 241.2 nm. Linearity was obtained in the concentration range of 1 – 12 μg/ml. Method B is first order derivative spectrophotometric method and involved estimation of carvedilol in 0.1 N HCl usingt the first- order derivative technique at 251 nm as maxima and 290.8 nm as minima. Calibration curve was prepared by plotting the absorbance difference between maxima and minima versus concentration. Linearity was obtained in the concentration range of 2- 20 μg/ml. Method C is area under curve (AUC) method. The method involved calculation of integrated value of absorbance with respect to the wavelength between two selected wavelength 246 nm and 228.6 nm, respectively. Linearity was obtained in the concentration range of 2- 20 μg/ml. These methods were successfully applied to pharmaceutical formulations because no interferences from tablet excipients were found. The suitability of these methods for the quantitative determination of cavedilol was proved by validation. The proposed methods were found to be simple, sensitive, accurate, precise, rapid and economical for the routine quality control application in pharmaceutical formulations.
VALIDATED SPECTROPHOTOMETRIC METHODS FOR THE DETERMINATION OF RALOXIFENE HYDROCHLORIDE IN PHARMACEUTICALS
BASAVAIAH,K; ANIL KUMAR,U R; THARPA,KALSANG; VINAY,K B;
Journal of the Chilean Chemical Society , 2008, DOI: 10.4067/S0717-97072008000300020
Abstract: two new simple, precise, rapid and extraction-free spectrophotometric methods are proposed for the determination of raloxifene hydrochloride (rlx) using bromate-bromide mixture and two dyes, methylene blue and rhodamine b, as reagents. the methods entail the addition of a known excess of bromate-bromide mixture to rlx in hydrochloric acid medium followed by determination of residual bromine by reacting with a fixed amount of either methylene blue and measuring the absorbance at 665 nm (method a) or rhodamine b and measuring the absorbance at 555 nm (method b). the amount of bromate reacted corresponds to the amount of rlx. in both the methods, the absorbance is found to increase linearly with the concentration of rlx. under the optimum conditions, rlx could be assayed in the concentration ranges 0.5-5.0 and 0.1-2.0 μg ml-1 from method a and method b, respectively. the apparent molar absorptivities are calculated to be 7.0x104 and l.1x105 l mol-1cm-1 for method a and method b, respectively, and the corresponding sandell sensitivity valúes are 0.0073 and 0.0048 μg cm-2. the limits of detection and quantification have also been reported for both the spectrophotometric methods. the overall reproducibility of the methods was excellent and recoveries were 98.3-102.5% and 98.2-103.2% for method a and method b, respectively. the proposed methods can be readily utilized for bulk drug and in pharmaceutical formulations
VALIDATED SPECTROPHOTOMETRIC METHODS FOR THE DETERMINATION OF RALOXIFENE HYDROCHLORIDE IN PHARMACEUTICALS  [cached]
K BASAVAIAH,U R ANIL KUMAR,KALSANG THARPA,K B VINAY
Journal of the Chilean Chemical Society , 2008,
Abstract: Two new simple, precise, rapid and extraction-free spectrophotometric methods are proposed for the determination of raloxifene hydrochloride (RLX) using bromate-bromide mixture and two dyes, methylene blue and rhodamine B, as reagents. The methods entail the addition of a known excess of bromate-bromide mixture to RLX in hydrochloric acid medium followed by determination of residual bromine by reacting with a fixed amount of either methylene blue and measuring the absorbance at 665 nm (Method A) or rhodamine B and measuring the absorbance at 555 nm (Method B). The amount of bromate reacted corresponds to the amount of RLX. In both the methods, the absorbance is found to increase linearly with the concentration of RLX. Under the optimum conditions, RLX could be assayed in the concentration ranges 0.5-5.0 and 0.1-2.0 μg mL-1 from method A and method B, respectively. The apparent molar absorptivities are calculated to be 7.0x10(4) and l.1x10(5) L mol-1cm-1 for method A and method B, respectively, and the corresponding Sandell sensitivity valúes are 0.0073 and 0.0048 μg cm-2. The limits of detection and quantification have also been reported for both the spectrophotometric methods. The overall reproducibility of the methods was excellent and recoveries were 98.3-102.5% and 98.2-103.2% for method A and method B, respectively. The proposed methods can be readily utilized for bulk drug and in pharmaceutical formulations
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