Padmarajaiah Nagaraja, Shailendra Naik, Ashwinee Shrestha and Anantharaman Shivakumar
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Basavaraj Hiremath and Bennikallu Mruthyunjayaswamy
Development and validation of spectrophotometric methods for determination of ceftazidime in pharmaceutical dosage forms
Two spectrophotometric methods for the determination of ceftazidime (CFZM) in either pure form or in its pharmaceutical formulations are described. The first method is based on the reaction of 3-methylbenzothiazolin-2-one hydrazone (MBTH) with ceftazidime in the presence of ferric chloride in acidic medium. The resulting blue complex absorbs at λmax 628 nm. The second method describes the reaction between the diazotized drug and N-(1-naphthyl)ethylenediamine dihydrochloride (NEDA) to yield a purple colored product with λmax at 567 nm. The reaction conditions were optimized to obtain maximum color intensity. The absorbance was found to increase linearly with increasing the concentration of CFZM; the systems obeyed the Beer's law in the range 2-10 and 10-50 μg mL-1 for MBTH and NEDA methods, resp. LOD, LOQ and correlation coefficient values were 0.15, 0.79 and 0.50, 2.61. No interference was observed from common excipients present in pharmaceutical formulations. The proposed methods are simple, sensitive, accurate and suitable for quality control applications.
Mohammed Abonassif, Mohammed Hefnawy, Mohamed Kassem and Gamal Mostafa
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B. S. Sultry
Bahia Abbas Moussa, Marianne Alphonse Mahrouse, Mahmoud Ali Hassan and Michael Gamal Fawzy
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Haitham Alrabiah, Abdulrahman Al-Majed, Mohammed Abounassif and Gamal A.E. Mostafa
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Two reversed-phase high performance liquid chromatography analytical methods (Method I and Method II) for determination of assay of recombinant human thrombin in pharmaceutical formulations were developed and validated. Analysis was performed on chromatographic system Agilent 1200 series SL with diode array detection and mass selective detection.
Method I was intended for faster determination of thrombin assay. Gradient programme was optimised to achieve sufficient separation and acceptable runtime. Chromatographic analysis was performed on analytical column Grace Vydac, C4 250 × 4.6 mm, 5 mm. Method II is Method I adapted to use the mass selective detector. Chromatographic separation was performed on analytical column Zorbax 300SB-C8 SolvSaver Plus, 150 × 3 mm, 3.5 mm. Both analytical methods were validated with respect to specificity, linearity, precision and accuracy. The response of thrombin was a linear function of concentration over the range 0.1-1.0 mg/ml. Precision and accuracy of thrombin was evaluated at three concentration levels low (0.2 mg/ml), medium (0.4 mg/ml) and high (0.8 mg/ml).
Both validated methods have been successfully applied for determination of assay and thrombin degradation products in pharmaceutical formulations.
Marcin Gackowski, Marcin Koba, Katarzyna Mądra-Gackowska and Stefan Kruszewski
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Aura Rusu, Maria-Alexandra Sbanca, Nicoleta Todoran and Camil-Eugen Vari
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Esam Bakir, Mohamed Gouda, Ahmed Alnajjar and Waleed E. Boraie
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