医薬品分析化学: オープンアクセス
オープンアクセス

概要

ヒト血漿中のシロドシンおよびシロドシン β-D-グルクロニドの推定のための高性能 LCMS 法の開発と検証

シーバ・マノージ・ナイル、ラヴィ・クマールP、デニッシュ・カリア

The aim of present study is to development and validation of analytical methods for estimation of Silodosin and Silodosin β-D-Glucuronidein human plasma in API, method in LCMS. Silodosin is a prescription medication that acts as an alpha-adrenergic blockers used in the treatment for men with benign prostatic hyperplasia, presently commercially available and marketed as Rapaflo in USA and Rapilif, Silodal in other countries worldwide. Drug showed linearity in the concentration range of 0.502 ng/ml to 207.376 ng/ml for Silodosin and 4.121 ng/ml to 302.836 ng/ml for Silodosin β-D-Glucuronide with correlation coefficient consistently greater than 0.99 for Silodosin and Silodosin β-D-Glucuronide. Mass parameters, 496.2/261.0 and 672.2/479.3/261.2 were chosen for analysis by Solid phase extraction method. Different validation parameters to be considered are Accuracy, Precision, Repeatability, Intermediate Precision, Specificity, Detection Limit, Quantitation Limit, and Linearity Range. The results were found to be acceptable as per the guidelines of International Conference on Harmonization (ICH). Both the methods are found to be novel, rapid, linear, precise, accurate, robust and rugged and can be successfully applied for the routine analysis of Silodosin and Silodosin β-D-Glucuronide. The methods are also found to be useful and economical.