Fast and Sensitive HPLC-ESI-MS/MS Method for Etoricoxib Quantification in Human Plasma and Application to Bioequivalence Study

Etoricoxib is a non-steroidal anti-inflammatory drug (NSAID) used to treat pain and inflammation. The objective of the current study was to develop a sensitive, fast and high-throughput HPLC-ESI-MS/MS method to measure etoricoxib levels in human plasma using a one-step methanol protein precipitation technique. A tandem mass spectrometer equipped with an electrospray ionization (ESI) source operated in a positive mode and multiple reaction monitoring (MRM) were used for data collection. The quantitative MRM transition ions were m/z 359.15 > 279.10 and m/z 363.10 > 282.10 for etoricoxib and IS. The linear range was from 10.00 to 4000.39 ng/mL and the validation parameters were within the acceptance limits of the European Medicine Agency (EMA) and Food and Drug Analysis (FDA) guidelines. The present method was sensitive (10.00 ng/mL with S/N > 40), simple, selective (K prime > 2), and fast (short run time of 2 min), with negligible matrix effect and consistent recovery, suitable for high throughput analysis. The method was used to quantitate etoricoxib plasma concentrations in a bioequivalence study of two 120 mg etoricoxib formulations. Incurred sample reanalysis results further supported that the method was robust and reproducible

Guideline for herbal medicine research

Herbal medicine is widely used in Traditional and Complementary Medicine (T&CM) practices. With its increasing use within the Malaysian community, there needs to be more specific guidance on the requirements for herbal medicine research to produce evidence-based herbal medicine products with therapeutic claims. Therefore, the pathway of herbal product development involving preclinical and clinical research must be well outlined in tandem with the ‘Guideline on Natural Products with Therapeutic Claim’ from the regulators. The primary purpose of this guideline is to provide structured guidance to be utilised by researchers, academicians, clinicians, T&CM practitioners, and relevant stakeholders of the herbal industry. This guideline outlines a concise yet informative description of the prerequisites and processes involved in planning and conducting herbal medicine-related research in the Malaysian context. This guideline will bridge the gap often associated with the population's demand for other treatment options besides conventional medicine. This effort will also help accommodate the growing interest in herbal medicine research and spur the discovery of herbal products with therapeutic claims in Malaysia