Validated RP-HPLC method for the simultaneous determination of glucosamine sulphate and curcumin in cream formulation: A novel stability-indicating study

摘要

Purpose: To develop and validate a stability-indicating reverse phase-high performance liquid chromatography (RP-HPLC) method for the simultaneous determination of glucosamine sulphate (GS) and curcumin (Cur) in drug solution and formulation. Methods: The optimized chromatographic conditions were achieved by passing various compositions of mobile phases over different reverse phase chromatographic columns. Various validation parameters, including linearity, range, limit of detection (LOD), limit of quantification (LOQ), accuracy, precision, specificity and system suitability were performed and evaluated. Stability studies under stressed conditions were done to evaluate the effects of acid, alkali, oxidation, heat and degradation by UV light. Results: The validated method was linear over the concentration range of 0.094 to 1.5 mg/mL for GS and 0.125 to 1.5 mg/mL for Cur, with a correlation coefficient 0.999. The Intra and inter-day precision were 1.9 % for GS and 0.5 % for Cur, while accuracy was 96 and 102 % for GS and Cur, respectively. Stability studies showed that GS was highly sensitive to acid, alkali and oxidation and less sensitive to heat and UV. Cur was stable against acid, heat and oxidation but sensitive to alkali and UV. Conclusion: The developed and validated method was precise and accurate for both GS and Cur and can potentially be utilized for their identification and quantification at industrial, research and quality control laboratories.