Analytical Method Development and Validation of HPLC for Identification and Assay of N-2 Intermediate of a Therapeutic Pentasaccharide – Fonda Parinux

Author(s)

YeshwanthGoud, P., Giri, A., Chiranjeevi, K., Kanumuri, R.M., Sandhya, N.

Author's Affiliation

Abstract

A simple, accurate Reverse Phase High Performance Liquid Chromatographic (RP-HPLC) method with UV detector (210 nm) was developed and validated for identification, determination of assay and purity of Fonda-parinux intermediate (N-2) content in In-Process. The best separation was achieved with octadecylsilane column diameter (250*4.6 mm; 5 µ) by using a gradient mobile phase 10 mM potassium di-hydrogen phosphate (pH = 6.0 adjusted with 1 M potassium hydroxide solution) and acetonitrile in the ratio of 70:30. The mobile phase were prepared and pumped at a flow rate of 1 ml/min. The above method is validated using the following parameters: Specificity, linearity, accuracy, precision, LOD and LOQ as per the ICH-Q2 (R1) guidelines.

Keywords

Fonda Parinux, Octadecylsilane column, HPLC, Buffers, UV Detection

Cite This Article

YeshwanthGoud, P., Giri, A., Chiranjeevi, K., Kanumuri, R.M., Sandhya, N. (2015). Analytical Method Development and Validation of HPLC for Identification and Assay of N-2 Intermediate of a Therapeutic Pentasaccharide- Fonda Parinux, International Journal for Pharmaceutical Research Scholars (IJPRS), 4(2), 438-446.