International Journal of Pharmaceutical Investigation, 2020, 10, 2, 197-201.
DOI: 10.5530/ijpi.2020.2.36
Published: June 2020
Type: Original Article
Authors:
Sumanta Mondal
Institute of Pharmacy, GITAM (Deemed to be University), Visakhapatnam, Andhra Pradesh, INDIA.
Reddipalli Pushpalatha
Institute of Pharmacy, GITAM (Deemed to be University), Visakhapatnam, Andhra Pradesh, INDIA.
Prasenjit Mondal
Vaageswari Institute of Pharmaceutical sciences, Ramakrishna Colony, Karimnagar, Telangana, INDIA.
Ashes Sinha Mahapatra
Institute of Pharmacy, GITAM (Deemed to be University), Visakhapatnam, Andhra Pradesh, INDIA.
Dipankar Shit
Institute of Pharmacy, GITAM (Deemed to be University), Visakhapatnam, Andhra Pradesh, INDIA.
Anik Kumar Das
Institute of Pharmacy, GITAM (Deemed to be University), Visakhapatnam, Andhra Pradesh, INDIA.
Sabyasachi Biswal
Institute of Pharmacy, GITAM (Deemed to be University), Visakhapatnam, Andhra Pradesh, INDIA.
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.
Keywords: Lercanidipine, HPLC, Method development, ICH guidelines, Validation.