Development and Validation of an RP-HPLC Analytical Method for Determination of Lisinopril in Full and Split Tablets

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