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标题:Validated chromatographic methods for the simultaneous determination of Mometasone furoate and Formoterol fumarate dihydrate in a combined dosage form
时间:2019-12-03 09:39:12
DOI:10.1016/j.bfopcu.2016.02.001
作者:Merey, Hanan A.; El-Mosallamy, Sally S.; Hassan, Nagiba Y.
关键词:Mometasone furoate;Formoterol fumarate dihydrate;TLC-densitometry;High performance liquid chromatography;Isocratic elution
出版源: 《Bulletin of Faculty of Pharmacy Cairo University》 ,54 (1) :99-106
摘要:Two chromatographic methods were developed and validated for the simultaneous determination of Mometasone furoate (MO) and Formoterol fumarate dihydrate (FOR). Combination of MO and FOR is used for the treatment of asthma in patients suffering from reversible obstructive airway disease. The first chromatographic method was based on using aluminum TLC plates pre-coated with silica gel GF254as the stationary phase and chloroform:ethyl acetate:methanol:toluene:formic acid (5:2:2:2:0.1, by volume) as the mobile phase followed by densitometric measurement of the separated bands at 233nm. The second method is a high performance liquid chromatographic method for the separation and determination of MO and FOR using reversed phase C18column with isocratic elution. The mobile phase composed of methanol: 0.5% ammonium acetate pH adjusted with acetic acid (80:20, v/v) at a flow rate of 1.0mL/min. Quantitation was achieved with UV detection at 220nm. The specificity of the developed methods was investigated by analyzing the pharmaceutical dosage form. The validity of the proposed methods was assessed using the standard addition technique. The obtained results were statistically compared with those obtained by the reported methods, showing no significant difference with respect to accuracy and precision atp=0.05.
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目录:
  • Validated chromatographic methods for the simultaneous determination of Mometasone furoate and Formoterol fumarate dihydrate in a combined dosage form
    • 1 Introduction
    • 2 Experimental
      • 2.1 Instruments
      • 2.2 Materials and reagents
        • 2.2.1 Pure standard
        • 2.2.2 Pharmaceutical dosage form
        • 2.2.3 Chemicals and reagents
        • 2.2.4 Standard solutions
        • 2.2.5 Working Solutions
      • 2.3 Procedures
        • 2.3.1 Construction of the calibration curves
          • 2.3.1.1 For TLC-spectrodensitometric method
          • 2.3.1.2 For HPLC method
        • 2.3.2 Application to pharmaceutical formulations
    • 3 Results
    • 4 Discussion
      • 4.1 Method validation
        • 4.1.1 System suitability
        • 4.1.2 Linearity and ranges
        • 4.1.3 Accuracy
        • 4.1.4 Precision
        • 4.1.5 Specificity
        • 4.1.6 Robustness
    • 5 Conclusion
    • Conflict of interest
    • References

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