RP-HPLC Method Development and Validation for Determination of Lisinopril and Amlodipine in Tablet Dosage form

Author: Ghogare R.C. and Godge R.K.

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Abstract

Analytical method development involves screening various column and eluent conditions, method optimization includes iterative testing of various separation conditions of the HPLC method and is performed to achieve the best possible resolution, speed, and reproducibility, robustness testing and method validation. Objective: The present study was aimed to develop a rapid, accurate, linear, and sensitive and validate high performance liquid chromatographic [RP-HPLC] method for determination of lisinopril and amlodipine in pharmaceutical dosage form. Methods: The chromatographic separation was performed on kromasil-C18 column [4.5 x 250 mm; 5 μm] using a mobile phase consisting of Methanol: 0.1% OPA in water (70:30 v/v). The flow rate is 1.0 ml/min and the detection was carried out at 210nm. Results: The chromatographic condition, the peak retention time of lisinopril and amlodipine were found to be 1.82 min and 2.68 min respectively. The method was validated as per ICH Q2 R1 guidelines. The calibration curve was found to be linear in the concentration range of 2-30 μg/ml for lisinopril and amlodipin. The limit of detection and quantification was found to be 0.219μg/ml and 0.665μg/ml for lisinopril and 0.228μg/ml and 0.691μg/ml for amlodipine respectively. Conclusion: A new sensitive, simple reverse-phase high-performance liquid chromatography [RP-HPLC] method has been developed and validated for the determination of amlodipine and lisinopril. The proposed method can be used for routine determination of amlodipine and lisinopril.

Keywords

Lisinopril, Amlodipine, Method validation, RP-HPLC

Conclusion

Proposed study describes a new RP-HPLC method for the estimation of Lisinopril and amlodipine combination in mixture using simple mobile phase with low buffer concentration compared to the reported method. The method gives good resolution between both the compounds with a short analysis time (<10 min). The method was validated and found to be simple, sensitive, accurate and precise. Percentage of recovery shows that the method is free from interference of the excipient used in the formulation. Therefore, the proposed method can be used for routine analysis of Lisinopril and amlodipine in their combined dosage form.

References

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How to cite this article

Ghogare R.C. and Godge R.K. (2023). RP-HPLC Method Development and Validation for Determination of Lisinopril and Amlodipine in Tablet Dosage form. Biological Forum – An International Journal, 15(6): 735-738.