Development And Validation Of Stability Indicating Rp-Hplc Method For The Estimation Of Ramipril And Cilnidipine In Bulk And Pharmaceutical Dosage Form

Abstract

Objective: A Simple, accurate, specific and rugged reverse phase liquid chromatographic method was developed and validated for the simultaneous estimation of Ramipriland Cilnidipine in bulk and pharmaceutical dosage form.

Method: A simple reverse phaseisocratic elution has been developed to separate the all four active ingredients using water and acetonitrile was used as mobile phase in ratio of 60:40 v/v. A isocratic elution has been developed and validated, on a reverse phase X-Bride Phenyl column (150 X4.6 mm, 3.5μ) with a flow rate of 1 mL/min by monitoring at 240 nm of wavelength.

Results: The mean retention times of Lamivudine, Ramipril and Cilnidipine were found to be 3.156and 6.889 min respectively. Linearity of Ramipriland Cilnidipine was found to be 2.5-15 μg/mL and 2.5-15 μg/mLrespectively. The accuracy of the proposed method was determined by performing recovery studies and was found to be between 98-102%. The repeatability testing for both sample and standard solutions was found as %RSD<2.0% which is within the acceptable limits showing that the method is precise as well. The LOD and LOQ were found to be 0.3 and 1.0 μg/ml for Ramipril, 0.3 and 1.0 μg/ml for Cilnidipine respectively.

Conclusion: The proposed method was validated in terms of linearity, range, accuracy, precision, specificity, robustness and stability studies and the method is successfully applied for the estimation of RamiprilandCilnidipinein combined tablet dosage form.