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

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.