Analytical method development and validation of cilnidipine and ramipril by using reverse phase high performance liquid chromatography

Abstract

Objective: the current investigation was pointed at developing and progressively validating novel, simple,
responsive and stable rp-hplc method for the measurement of active pharmaceutical ingredients of cilnidipine and
ramipril.
Methods: a simple, selective, validated and well-defined stability that shows isocratic rp-hplc methodology for the
quantitative determination of cilnidipine and ramipril. The chromatographic strategy utilized x-bridge phenyl
column of dimensions 250x4.6 mm, 5 micron, using isocratic elution with a mobile phase of acetonitrile and 0.1
percent triethyl amine (60:40). A flow rate of 1 ml/min and a detector wavelength of 242 nm utilizing the pda
detector were given in the instrumental settings. Validation of the proposed method was carried out according to an
international conference on harmonization (ich) guidelines.
Results: lod and loq for the two active ingredients were established with respect to test concentration. The
calibration charts plotted were linear with a regression coefficient of r2 > 0.999, means the linearity was within the
limit. Recovery, specificity, linearity, accuracy, robustness, ruggedness were determined as a part of method
validation and the results were found to be within the acceptable range.
Conclusion: the proposed method to be fast, simple, feasible and affordable in assay condition. During stability
tests, it can be used for routine analysis of the selected drugs.