Application of reusable flat-membrane in electro-membrane extraction for tamsulosin hydrochloride determination in cleaning validation samples of sterile production line equipment by RP-HPLC.

Abstract

In order to ensure compliance with the current Good Manufacturing Practice (cGMP), cleaning process of pharmaceutical manufacturers should be validated. This study was aimed to utilize a reusable flat-membrane in the electromembrane extraction (EME) for isolation of tamsulosin hydrochloride (TMS) from rinse samples of sterile production of pharmaceutical line. Moreover, validation of mentioned method was done. The residual concentration of TMS was determined by RP-HPLC. Effective parameters such as pH, applying voltage and extraction time were optimized individually. Optimum conditions were found 12, 100 V and 10 min for pH, applying voltage and extraction time, respectively. Figures of merit were calculated under optimum conditions, therefore, linear range and limit of detection (LOD) were obtained 0.5-1000 ng mL-1 with a good coefficient of determination (R2=0.9901) and 0.05 ng mL-1, respectively. Last but not least, RSD of determination was found 0.67% which shows a satisfactory repeatability. According to the obtained results, proposed method is a precise, accurate, relatively fast and applicable route to determine TMS concentrations in rinse samples.