采用流动注射分析法对法莫替丁片溶出度试验进行优化与验证

Optimization and validation of a dissolution test for famotidine tablets using flow injection analysis.

作者信息

Tzanavaras Paraskevas D, Verdoukas Aspasia, Balloma Theodora

机构信息

Quality Control Department, Cosmopharm Ltd., P.O. Box 42, Korinthos 20100, Greece.

出版信息

J Pharm Biomed Anal. 2006 May 3;41(2):437-41. doi: 10.1016/j.jpba.2005.12.011. Epub 2006 Jan 18.

DOI:10.1016/j.jpba.2005.12.011

PMID:16413732

Abstract

A dissolution test for famotidine tablets was optimized and validated using flow injection analysis (FIA). The effect of dissolution parameters such as pH, medium and stirring speed was studied, while the ruggedness of the procedure was validated. All measurements were performed using a simple direct spectrophotometric flow injection assay (lambdamax=265 nm) that has also been optimized and fully validated in terms of linearity, limit of detection, precision, selectivity and accuracy. Linearity was obeyed in the range 50-150% of famotidine (20-60 mg L-1), while the detection limit (0.1 mg L-1) and repeatability (sr<1.0%, n=12) were satisfactory. The sampling rate was 30 h-1. The dissolution results during quality and stability control of two batches of famotidine tablets obtained by the flow injection method were in good agreement with high-performance liquid chromatography (HPLC).

摘要

采用流动注射分析（FIA）对法莫替丁片的溶出度试验进行了优化和验证。研究了pH值、介质和搅拌速度等溶出参数的影响，同时对该方法的耐用性进行了验证。所有测量均使用简单的直接分光光度流动注射分析法（λmax = 265 nm）进行，该方法在线性、检测限、精密度、选择性和准确性方面也进行了优化和充分验证。法莫替丁在50 - 150%（20 - 60 mg L-1）范围内符合线性关系，检测限（0.1 mg L-1）和重复性（sr < 1.0%，n = 12）令人满意。进样速率为30 h-1。通过流动注射法获得的两批法莫替丁片在质量控制和稳定性控制期间的溶出结果与高效液相色谱法（HPLC）结果高度一致。