Validation of rapid RP-HPLC method for concurrent quantification of amlodipine and celecoxib in pure and formulation using an experimental design

•This is the first HPLC method for the simultaneous determination of amlodipine and celecoxib.•Even though the difference in the amount of both analytes is large in the formulation (2.5:200, 5:200, and 10:200 µg/mL), both analytes can be determined with high accuracy without the need for a prior ste...

Full description

Saved in:
Bibliographic Details
Published in:Microchemical journal 2020-01, Vol.152, p.104365, Article 104365
Main Authors: Attimarad, Mahesh, Venugopala, Katharigatta Narayanaswamy, SreeHarsha, Nagaraja, Aldhubiab, Bandar E., Nair, Anroop Balachandran
Format: Article
Language:English
Subjects:
Amlodipine
Celecoxib
Factorial design
Formulation
HPLC
Robustness
Validation
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:•This is the first HPLC method for the simultaneous determination of amlodipine and celecoxib.•Even though the difference in the amount of both analytes is large in the formulation (2.5:200, 5:200, and 10:200 µg/mL), both analytes can be determined with high accuracy without the need for a prior step.•Due to the short analysis time (less than 4 min), the proposed method could be used for routine quality control in pharmaceutical industries.•The robustness of the method was confirmed by fractional factorial design.•The proposed method was statistically compared with reported methods. Objective of the proposal was to establish rapid, economical, and robust liquid chromatographic procedure to perform quality control of a pharmaceutical preparation containing amlodipine and celecoxib using an experimental design. The proposed new high-performance liquid chromatography (HPLC) procedure involves isocratic separation using sodium phosphate buffer (pH 5.6): acetonitrile: methanol in a ratio 30:55:15 (v/v) as the mobile phase on a Zorbax C18 (150 mm) reverse-phase (RP)-HPLC column. The analysis was performed at 25 °C, using a flow rate of 1.2 mL/minute. The column elutes were detected at 239 nm and etoricoxib has been selected as an internal standard (IS). The calibration curve exhibited good linearity in the range of 5–30 µg/mL of amlodipine and 50–500 µg/mL of celecoxib with a good correlation coefficient (r2 > 0.999). The precision and accuracy were presented in terms of%RSD and%RE and were in an acceptable range (
ISSN:0026-265X
1095-9149
DOI:10.1016/j.microc.2019.104365