Stability indicating RP-HPLC method for the determination of amlodipine besylate

Authors

  • Sumera Kousar Shadan College of pharmacy, Peerancheru. Hyderabad, Andhra Pradesh 500086
  • Farhana begum Shadan College of pharmacy, Peerancheru. Hyderabad, Andhra Pradesh 500086

DOI:

https://doi.org/10.61096/ijpar.v5.iss1.2016.56-77

Keywords:

Amlodipine Besilate, LOD & LOQ

Abstract

A simple, specific, sensitive, accurate, precise, economic & reproducible RP -HPLC method was developed for the  amlodipine and  validated. The proposed method utilises the  Agilent technologies: Agilent 1260&1290 series. Column ZORBAX C18 100 x 4.6mm with 3.5microns pa rticle size and a software of ECZ chrome elite, 0.2µ Millipore filter paper and by using optimum mobile phase methanol: acetonitrile: Water (80:10:10) at flow rate of 1.0ml/min at 35+/- 2oc temperature. The eluent was detected at 230nm by using U.V detecto r. The retention time of Amlodipine besylate was found to be 1.5 min and is economically feasible. The linearity was observed at 2-50µ.g/ml. The mean recoveries were found to be 100±2%. The method was validated for system suitability,  specificity,  linearity,  accuracy,  precision,  ruggedness,  robustness,  LOD  &  LOQ  as  per  ICH guidelines. Limit of detection and Limit of quantification of the method was found to be 2.93µg/ml and 8µg/ml shows that the developed method has adequate sensitivity. (r 2 > 0.99), %R.S.D of precision was found to be <2. The developed method was used for the stability, forced degradation studies. It can be used in the quality control and in-vitro dissolution of the drug. The proposed method is precise, economic, with high sensitivity and less retention time.

Downloads

Published

2016-01-12

How to Cite

Sumera Kousar, & Farhana begum. (2016). Stability indicating RP-HPLC method for the determination of amlodipine besylate. IJPAR JOURNAL, 5(1), 56–77. https://doi.org/10.61096/ijpar.v5.iss1.2016.56-77