Development and Validation of an SEC-HPLC Method for the Analysis of Lenogratsim (rHuG-CSF) in Pharmaceutical Formulations

被引：1

作者：

Tonic-Ribarska, Jasmina ^{[1
]}

Brezovska, Katerina ^{[1
]}

Trajkovic-Jolevska, Suzana ^{[1
]}

机构：

[1] Ss Cyril & Methodius Univ, Fac Pharm, Skopje 1000, Macedonia

来源：

JOURNAL OF LIQUID CHROMATOGRAPHY & RELATED TECHNOLOGIES | 2009年 / 32卷 / 17期

关键词：

Aggregates; Lenograstim; Pharmaceutical formulations; Size-exclusion HPLC; Validation; COLONY-STIMULATING FACTOR; RHG-CSF; AGGREGATION; CHROMATOGRAPHY; INHIBITION; STABILITY;

D O I：

10.1080/10826070903249716

中图分类号：

Q5 [生物化学];

学科分类号：

071010 ; 081704 ;

摘要：

A simple and sensitive size exclusion HPLC method was developed and validated for the analysis of lenograstim (rHuG-CSF) in pharmaceutical formulations. Analyses were performed on a Waters HPLC system employing a Fractogel(R) EMD BioSEC column and isocratic elution with phosphoric acid (pH 2.5; 0.1 M) containing 150 mmol L-1 NaCl at a flow rate of 2.0 mL min(-1). The validation results demonstrate that the proposed method is suitable for determination of lenogratsim in pharmaceutical formulations. Furthermore, the proposed SEC-HPLC method was able to separate and detect the aggregates and the intact protein.

引用

页码：2545 / 2555

页数：11

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