Table of Contents
Chromatography Research International
Volume 2016 (2016), Article ID 1596021, 7 pages
http://dx.doi.org/10.1155/2016/1596021
Research Article

Validated Stability Indicating Chromatographic Method for the Simultaneous Estimation of Camylofin with NSAID Drugs and a New Approach of Method Transfer from Classical HPLC to a Modern UPLC Instrument

1Center of Excellence in Drug Discovery, NFDD Complex, Department of Chemistry, Saurashtra University, Rajkot, Gujarat 360005, India
2Matushri Virbaima Mahila Science & Home Science College, Rajkot, India

Received 27 April 2016; Revised 13 September 2016; Accepted 19 September 2016

Academic Editor: Susana Casal

Copyright © 2016 Sheetal Makwana et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

The presented work describes the method development of simultaneous determination of camylofin dihydrochloride (CMF), diclofenac potassium (DCF), and Paracetamol (PCM) using reversed phase high performance liquid chromatography (HPLC-UV) and the method was further transferred to a new generation instrument, ultraperformance liquid chromatography (UPLC-PDA). The detailed validation was carried out for the combination tablet formulation of CMF and DCF by UPLC-PDA. From the method development study, Acquity UPLC HSS C18 (2.1 × 50 mm, 1.8 μm) was finally selected for validation. The satisfactory results were observed for peak shape, retention time, and resolution with a mobile phase of 20 mM ammonium acetate buffer (pH 3.0 with dilute orthophosphoric acid) : methanol (33 : 67 v/v). The isocratic elution of mobile phase was carried out at a flow rate of 0.250 mL/min and detection at 220 nm. Both drugs were efficiently separated out in less than 3.5 min with 1.1 and 3.2 min of retention time of the CMF and DCF with 11.87 of resolution. The linearity was obtained in the 20.0–80.0 μg/mL range of concentration with 0.9998 of correlation coefficients for the substances. The method was analyzed for specificity with detailed force degradation study, which is a simple, precise, and accurate method, as per the International Conference on Harmonization (ICH) guidelines.