Asian Journal of Pharmaceutical Research

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AQBD Approach in Chemo Metric Assisted Method Development for the Estimation of Ciprofloxacin and Metronidazole by UV-VIS Spectrophotometry


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1 Dept of Post Graduate in Pharmaceutical Quality Assurance, SVPM’S College of Pharmacy, Malegaon (BKII) Baramati Dist Pune, Maharashtra, India
     

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Quality by design is applied for the development of various pharmaceutical processes including analytical methods. By applying QbD approach chemometric based analytical method was developed for the estimation of Ciprofloxacin (CFN) and Metronidazole (MND) by UV-VIS spectrophotometry. Solvent Distilled water was utilised and 271.5nm and 319nm were the wavelength of absorbance measurement for CFN and MND respectively. Effect of input variables on spectrum characteristics were studied for selection of critical parameters and developed method was validated as per ICH Q 2 R1 regulatory guidelines. Linearity of both the drugs was ascertained over the conc range 1 -14mcg/ml. The accuracy of assay was found 98% for CFN and 100.78% for MND; and the precision study was shown acceptable data as %RSD data varied from 0.6369 to 1.3192 for CFN and from 0.5509 to 1.2171 for MND. The developed method is rigid, robust and efficient for the estimation of CFN and MND from the composition of dosage form. QbD was applied to build rigid robust method through risk assessment at early stage and defining the design space at the later stage.


Keywords

QbD, Ciprofloxacin, Metronidazole, ICH, simultaneous equation
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  • AQBD Approach in Chemo Metric Assisted Method Development for the Estimation of Ciprofloxacin and Metronidazole by UV-VIS Spectrophotometry

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Authors

Shweta Jogdand
Dept of Post Graduate in Pharmaceutical Quality Assurance, SVPM’S College of Pharmacy, Malegaon (BKII) Baramati Dist Pune, Maharashtra, India
Karuna Mane
Dept of Post Graduate in Pharmaceutical Quality Assurance, SVPM’S College of Pharmacy, Malegaon (BKII) Baramati Dist Pune, Maharashtra, India
Rohit Jadhav
Dept of Post Graduate in Pharmaceutical Quality Assurance, SVPM’S College of Pharmacy, Malegaon (BKII) Baramati Dist Pune, Maharashtra, India
G K Dyade
Dept of Post Graduate in Pharmaceutical Quality Assurance, SVPM’S College of Pharmacy, Malegaon (BKII) Baramati Dist Pune, Maharashtra, India

Abstract


Quality by design is applied for the development of various pharmaceutical processes including analytical methods. By applying QbD approach chemometric based analytical method was developed for the estimation of Ciprofloxacin (CFN) and Metronidazole (MND) by UV-VIS spectrophotometry. Solvent Distilled water was utilised and 271.5nm and 319nm were the wavelength of absorbance measurement for CFN and MND respectively. Effect of input variables on spectrum characteristics were studied for selection of critical parameters and developed method was validated as per ICH Q 2 R1 regulatory guidelines. Linearity of both the drugs was ascertained over the conc range 1 -14mcg/ml. The accuracy of assay was found 98% for CFN and 100.78% for MND; and the precision study was shown acceptable data as %RSD data varied from 0.6369 to 1.3192 for CFN and from 0.5509 to 1.2171 for MND. The developed method is rigid, robust and efficient for the estimation of CFN and MND from the composition of dosage form. QbD was applied to build rigid robust method through risk assessment at early stage and defining the design space at the later stage.


Keywords


QbD, Ciprofloxacin, Metronidazole, ICH, simultaneous equation

References