Stability Indicating and Kinetic Determinations of Fluvastatin Sodium by RP-HPLC-DAD Method

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2.5 Kinetic Determination 2.5.1 Kinetic investigation of FVS in acidic degradation The kinetics of the acid degradation of FVS were evaluated in 0.1 M HCl at 70°C for different time periods. Solutions containing 1 mg/mL of the FVS were prepared in water. An appropriate aliquot was transferred into a volumetric flask, and diluted with 0.1 M HCl to give final concentration of 100µg/ml FVS. This solution was heated to 70°C and evaluated for time intervals of 30 min, 60 min and 120 min. Three samples were analyzed for each time interval. After the required time, 1 ml aliquots taken were transferred to a 10 mL volumetric flask and neutralized with 1 mL 0.1 M NaOH using pH meter. This solution was diluted with mobile phase to 20µg/ml of FVS solution for the HPLC analysis. The kinetic determinations were performed in the dark to exclude the possible degradation effect of light. 2.5.2 Kinetic investigation of FVS in oxidative degradation The kinetics of the acid degradation of FVS were evaluated in 3 % H2O2 at 70°C for different time periods. Solutions containing 1 mg/mL of the FVS were prepared in water. An appropriate aliquot was transferred into a volumetric flask, and diluted with 3 % H2O2 to give final concentration of 100µg/ml FVS. This solution was heated to 70°C, evaluated for time intervals of 30 min, 60 min and120 min. Three samples were analyzed for each time interval. After the required time, 1 ml aliquots taken transferred to a 10 ml volumetric flask and this solution was diluted with mobile phase to obtain 20µg/ml of FVS solution for the HPLC analysis. The concentrations of the remaining FVS determined at the different time intervals in the kinetic determinations were used in the plots. The plots were ln of concentra... ... middle of paper ... ...: 119–126 (2005). 22. W. Aman, K. Thoma, International Journal of Pharmaceutics 243: 33–41 (2002). 23. Onoue, Y. Tsuda, Pharmaceutical Research 23:156–164 (2006). 24. H.H. Tønnesen, International Journal of Pharmaceutics 225:1–14 (2001). 25. R.H. Clothier, Alternative to Laboratory Animal 35:515–519 (2007). 26. ICH topic Q2 (R1), Validation of analytical procedures: text and methodology, Geneva, Switzerland, 2005. 27. Bakshi, M., Singh, S., Journal of Pharmaceutical and Biomedical Analysis; 28; 1011–1040 (2002). 28. Swartz, M., Krull, I., LC-GC; 23, 586–593 (2005). 29. ICH-QA1 (R2); Stability Testing of New Drug Substances and Products, Geneva, Switzerland, 2003. 30. Ahuja, S.S., Advance Drug delivery Review; 59, 3–11 (2007). 31. K.A. Connors, G.R. Amidon, V.J. Stella, Chemical stability of Pharmaceuticals, A Handbook for Pharmacists, 2nd ed., Wiley, New York, 1986.

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