Article

A Stability Indicating Validated Method for the Determination of Lercanidipine Using Reverse Phase High Performance Liquid Chromatography

Sumanta Mondal1★, Reddipalli Pushpalatha1, Prasenjit Mondal2, Ashes Sinha Mahapatra1, Dipankar Shit1, Anik Kumar Das1, Sabyasachi Biswal1★ Corresponding author

  1. 1Institute of Pharmacy, GITAM (Deemed to be University), Visakhapatnam, Andhra Pradesh, INDIA.
  2. 2Vaageswari Institute of Pharmaceutical sciences, Ramakrishna Colony, Karimnagar, Telangana, INDIA.

CORRESPONDENCE

Sumanta Mondal

Institute of Pharmacy, GITAM (Deemed to be University), Visakhapatnam, Andhra Pradesh, INDIA.

mondalresearch@gmail.com

Received: 12-02-2020; Revised: 29-02-2020; Accepted: 18-03-2020.

Volume 10, Issue 2 · pp. 197–201 · PUBLISHED · DOI: 10.5530/ijpi.2020.2.36

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ABSTRACT

Objective:An accurate reverse phase High Performance liquid chromatography (RP-HPLC) method has been developed, validated and applied to stability indicating studies to determine Lercanidipine HCl in dosage form. Methods:Optimized chromatographic conditions were achieved by using Symmetry C18 Column, 250 mmx4.6 mm and 5μm particle size as stationary phase and Dihydrogen Orthophosphate Buffer: Methanol: ACN = (40 : 40 : 20) as eluent at flow rate 1.0 ml/min. UV detection was performed at 256nm. The developed method was validated and stability study was conducted as per ICH guidelines. Results:The retention time was found at 4.778 min. The method shows linearity over a range of 6 μg/ml to 40 μg /ml. The obtained correlation coefficient is 0.999. The LOD and LOQ values were 0.09 and 0.27 μg /ml. The acidic and alkaline stressed study shows more degradation of 8.181% and 7.241%. Conclusion: The present developed method was found stability indicating, easy and reliable method can be applied for routine analysis of lercanidipine in bulk drug and the Pharmaceutical formulations.

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    Mondal, S., Pushpalatha, R., Mondal, P., Mahapatra, A. S., Shit, D., Das, A. K., & Biswal, S. (). A Stability Indicating Validated Method for the Determination of Lercanidipine Using Reverse Phase High Performance Liquid Chromatography. International Journal of Pharmaceutical Investigation, 10(2), 197–201. https://doi.org/10.5530/ijpi.2020.2.36