Total views : 47
Development and Validation of a RP-HPLC method for Analysis of Cidofovir in Medicinal Form
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.
Method Development, Validation, RP - HPLC
- Cidofovir Monograph. Available from: Crossref. Date accessed: 13/07/2017.
- Loregian A. Separation methods for Acyclovir and related antiviral compounds. Journal of Chromatography B. 2001; 764(1-2):289-311. Crossref.
- France B. Separation methods for Antiviral phosphorus containing drugs. Journal Of Chromatography B. 2001; 764(1-2):1801-11.
- Santoyo S, de Jalon EG, Campanero MA, Ygartua P.Determination of Cidofovir in both skin layers and percutaneous penetration samples by HPLC. Journal of Pharmaceutical and Biomedical Analysis. 2002; 29(5):819-26.Crossref.
- Breddeman A, Hsien L, Tot E. Quantification of Cidofovir in human serum by LC-MS/MS for children.
- Journal of Chromatography B. 2008; 861(1):1-9.Crossref. PMid:18083075.
- Eriksson U, Peterson W, Boris A. Serine Peptide Phosphoester prodrugs of Cyclic Cidofovir. Synthesis, Transport and Antiviral activity. Molecular Pharmaceutics.2008; 5(4):598-609. Crossref. PMid:18481868 PMCid:PMC2629803.
- Q2 (R1) Validation Of Analytical Procedures: Text and Methodology
- There are currently no refbacks.
This work is licensed under a Creative Commons Attribution 3.0 License.