Simultaneous Quantitative Estimation of Lisinopril and Hydrochlorothiazide Residues Using HPLC for Cleaning Validation

Chemistry Journal of Moldova: General, Industrial and Ecological Chemistry

Imeda Rubashvili¹  Khatuna Makharadze²  Natela Karukhnishvili² 

[1] Petre Melikishvili Institute of Physical and Organic Chemistry, Ivane Javakhishvili Tbilisi State University, 31, Politkovskaya str., Tbilisi 0179, Georgia;Quality Control Laboratory, „Aversi-Rational“ Ltd, 14, Chirnakhuli str., Tbilisi 0198, Georgia;

关键词: lisinopril;    hydrochlorthiazide;    swab sampling;    rinse sampling;    hplc;    validation;   

DOI  :  10.19261/cjm.2020.669

来源: DOAJ

【 摘 要 】

A new, rapid and selective, HPLC method for simultaneous quantitative estimation of lisinopril and hydrochlorothiazide residues and sampling procedures from pharmaceutical manufacturing equipment surfaces were developed and validated. The sampling procedures have a good recovery (>80%). The limit of quantitation of the HPLC method - 0.155 µg/mL and 0.025 µg/mL for lisinopril and hydrochlorothiazide, respectively.

【 授权许可】

Unknown