Indian Journal of Science and Technology

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Development and Validation of a RP-HPLC method for Analysis of Cidofovir in Medicinal Form


Affiliations
1 Department of Chemistry, G. Pullaiah College of Engineering and Technology, Kurnool – 518002, Andhra Pradesh, India
2 Department of Chemistry, JNTUA College of Engineering, Anantapur – 515002, Andhra Pradesh, India
 

Objective: A novel RP-HPLC method has been developed for analysis of cidofovir in its available medicinal form. Method: Stationary phase was a sophisticated C-18 RP Column (250mm × 4.6mm). Mobile phase consisted of Ethylnitrile and 0.005M citric acid buffer (pH adjusted to 5.5) in 60:40 V/V ratio. Mobile phase flow rate was 1.0 ml per minute and Isocratic. UV detection wavelength was 260nm. Validation was carried according to ICH guidelines. Findings: The Retention time of both AP1 and the medicine was 3.88 minutes. Linearity was satisfied over the concentration range of 2 ppm to 10 ppm and r² value was 0.999. LOD and LOQ values were 0.067 ppm and 0.205 ppm respectively. Improvement: The Reported method was novel and all validation parameters met the criteria. Method can be used in quality control analysis.

Keywords

Method Development, Validation, RP - HPLC
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  • Development and Validation of a RP-HPLC method for Analysis of Cidofovir in Medicinal Form

Abstract Views: 266  |  PDF Views: 0

Authors

J. Mamatha
Department of Chemistry, G. Pullaiah College of Engineering and Technology, Kurnool – 518002, Andhra Pradesh, India
N. Devanna
Department of Chemistry, JNTUA College of Engineering, Anantapur – 515002, Andhra Pradesh, India

Abstract


Objective: A novel RP-HPLC method has been developed for analysis of cidofovir in its available medicinal form. Method: Stationary phase was a sophisticated C-18 RP Column (250mm × 4.6mm). Mobile phase consisted of Ethylnitrile and 0.005M citric acid buffer (pH adjusted to 5.5) in 60:40 V/V ratio. Mobile phase flow rate was 1.0 ml per minute and Isocratic. UV detection wavelength was 260nm. Validation was carried according to ICH guidelines. Findings: The Retention time of both AP1 and the medicine was 3.88 minutes. Linearity was satisfied over the concentration range of 2 ppm to 10 ppm and r² value was 0.999. LOD and LOQ values were 0.067 ppm and 0.205 ppm respectively. Improvement: The Reported method was novel and all validation parameters met the criteria. Method can be used in quality control analysis.

Keywords


Method Development, Validation, RP - HPLC



DOI: https://doi.org/10.17485/ijst%2F2017%2Fv10i34%2F160599