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Validation and Determination of Tamsulosin Hydrochloride Residue in Production Line Equipment by HPLC after In-tube Solid Phase Microextraction

Document Type : Original Paper

Authors

1 1 Research Laboratory of Spectroscopy & Micro and Nano Extraction, Department of Chemistry, Iran University of Science and Technology, P.O. Box 16846/11367, Narmak, Tehran, Islamic Republic of Iran

2 2 Zagros Darou, Tehran, Islamic Republic of Iran

Abstract

Ensuring about the cleanliness of the product line is a major approach on famous pharmaceutical companies. The aim of this study is validation of in-tube SPME (IT-SPME) method coupled with HPLC-UV for microextraction and determination of tamsulosin hydrochloride (TAM) residue from swab samples of pharmaceutical production lines. The inner surface of stainless steel tube which is proposed as device for TAM extraction was coated by Polypyrrole (PPY) via chemical polymerization reaction. After five cycles of polymerization, the tube was coated with acceptable stability that can overcome five extractions. Three practical parameters such the effect of pH, ionic strength and extraction cycle were optimized. The maximum extraction yield was achieved when no salt added, pH was adjusted at 8 and extraction cycle was chosen at 11 times. Then a mixture of sodium perchlorate buffer (pH=2) and acetonitrile (35:65) was utilized as desorption solvent. Linear dynamic range (LDR), limit of detection (LOD) and relative standard deviation (RSD) of proposed method were calculated between 5-2500 ng mL-1, 1.62 ng mL-1 and 1.23%, respectively. Moreover, the proposed method was compared with standard method of TAM residue determination from swab samples of pharmaceutical production lines. The results revealed that the proposed method can be utilized as an acceptable method for isolation and determination of TAM from swabbing samples.

Keywords

Main Subjects

References
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LC‐ESI‐MS/MS method for the quantification of tamsulosin in human plasma. Biomed. Chromatogr. 2005;19(10):709-19.

Journal of Sciences, Islamic Republic of Iran
Volume 34, Issue 1
March 2023
Pages 17-26
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