Research Information System
Pharmaceutical Chemistry Journal, vol.59, no.11, pp.1251-1259, 2026 (SCI-Expanded, Scopus)
Osteoarthritis is a prevalent degenerative joint disease characterized by the progressive loss of articular cartilage and is one of the leading causes of disability worldwide. Current treatment options for osteoarthritis remain limited, primarily consisting of symptomatic treatments such as intra-articular injections of glucocorticoids and hyaluronic acid preparations. Among the most commonly used corticosteroids for osteoarthritis treatment are betamethasone sodium phosphate (BSP) and betamethasone dipropionate (BD). Accurate identification and quantification of these corticosteroids in pharmaceutical formulations are essential to ensure compliance with analytical and regulatory standards. Thus, in this study a simple high-performance liquid chromatography method (isocratic method) has been developed and validated for the simultaneous determination of BSP and BD. Discovery® HS C18 Column (250, 4.6 mm, 5 μm) was used at 35°C. The mobile phase was prepared using a mixture of acetonitrile:water (75:25 v/v) containing 0.1% orthophosphoric acid. The flow rate was 1 mL/min and ultraviolet detection was at 241 nm. Elution was within 7 min. The developed method was validated according to the International Council for Harmonization (ICH) guidelines in terms of system suitability, linearity, limits of detection, and quantification, precision, accuracy, specificity, selectivity, and stability. The calibration curves for BSP and BD were linear over the concentration range 1.0–80.0 μg/mL, with correlation coefficients (R2) of 0.9998 for BSP and 1.0000 for BD. The retention times of BSP and BD were 2.37 and 5.15 min respectively. The method was found to be precise, accurate, and specific throughout the study. In conclusion, this method offers a simple, sensitive, and reliable approach to the simultaneous quantification of BSP and BD in intra-articular injectable formulations.