Development and Validation of an RP-HPLC Analytical Method for Determination of Lisinopril in Full and Split Tablets Fahelelbom Khairi M. S.1,*, Al-Tabakha Moawia M. M.2, Eissa Nermin A. M.1, Obaid Dana Emad Eddin1, Sayed Sadik1 1Department of Pharmaceutical Sciences, College of Pharmacy, Al Ain University of Science and Technology, P.O. Box 64141, Al Ain, UAE 2Department of Pharmaceutical Sciences, College of Pharmacy and Health Sciences, Ajman University, P.O. Box 346, Ajman, UAE *Corresponding Author E-mail: Khairi.mustafa@aau.ac.ae
Online published on 4 July, 2020. Abstract Objective The aim of this study is to develop and optimize a new an RP-HPLC method for the analysis of lisinopril from pure samples, full and split tablet dosage forms by investigating all relevant factors in order to obtain a simple, reproducible and sensitive technique for the quantitative determination of lisinopril. Method A number of chromatographic factors have been tested such as the mobile phase composition, retention rate, column temperature and the effect of excipients using C18 column as the stationary phase for the determination of lisinopril. While the tested mobile phase was a mixture of methanol, acetonitrile and phosphate buffer solution. Results The retention time of lisinopril was found to be 2.6 min at the flow rate of 1.0 ml/min. Excellent linearity was found for the drug concentrations in the range 40–200 μg/mL (r2= 0.9993). The small RSD value (< 4%) obtained indicate that the method is quite precise. The high percentage of recovery was 100.174% (range: 98.7 to 102.4%) which complies with all of pharmacopeias with SD of 1.1. The absence of additional peaks in the chromatogram indicates non-interference of the commonly used excipients in the tablets and hence the method is specific. The small values of LOD (0.210) and LOQ (0.636 μg/mL) obtained by this method indicate the sensitivity of the method. Conclusion The proposed RP-HPLC method is rapid, sensitive, precise and accurate for the determination of lisinopril. It can be reliably adopted for routine quality control analysis of lisinopril bulk and in its full and splitted tablet dosage forms Top Keywords Lisinopril tablet, HPLC analysis, Split tablet, chromatography, method development. Top |