A Critical Review on Analytical Methods for Recently Approved FDC Drugs: Pregabalin and Etoricoxib

Abstract

Fixed-dose combinations (FDCs) refer to products containing two or more active ingredients combined in a single dosage form. The FDCs are justified because of several advantages. These are a) potentiating therapeutic efficacy, b) reducing the incidences of adverse drug effects, c) having pharmacokinetic advantages, d) reducing pills burden, e) reducing the dose of individual drugs and f) decreasing the drug resistance development. A recently approved FDC of Pregabalin IP (75 mg) and Etoricoxib (60 mg) recommended to control neuropathic chronic back pain. Analytical methods are available for individual quantitation of pregabalin (PGB) and etoricoxib (ETC), but an effective and reliable analytical method has not been reported for their combination. Thus, the objective of this literature survey was to gather information on various analytical instrumental methods used so far for the individual quantitation of PGB and ETC in various matrices. Such data would be useful to the scientific community to develop a novel analytical method for the analysis of recently approved FDC of PGB and ETC. Various scientific databases were explored to meet the objectives, and the information is synchronized. The reported methods are high-performance liquid chromatography (48% & 53%), hyphenated techniques (54% & 21%), spectroscopy (50% & 34%), and high-performance thin-layer chromatography, or thin-layer chromatography (6% & 13%) for pregabalin and etoricoxib, respectively. All these methods were specific and selective for the analysis of individual drugs.

Keywords:

• Analytical methods
• chromatography
• FDC
• LC-MS
• spectroscopy

Acknowledgment

Authors are very thankful to Ramanbhai Patel College of Pharmacy to provide necessary library facilities to gather the information about PGB and ETC.

Conflicts of interest

Authors have no conflict of interest.