Development and Validation of UV-visible Spectrophotometry Method for Simultaneous Estimation of Rutin and Curcumin in Bulk Pharmaceuticals

Background

The primary objective of this study is to pioneer a novel UV spectrophotometric method, designed with simplicity and high sensitivity to accurately measure both Rutin and Curcumin simultaneously. Rutin has a therapeutic impact on treating chronic venous insufficiency and Curcumin’s pharmacological activities include anti-inflammatory, anti-hyperpigmentation, etc. An effort has been made to quantify Rutin and Curcumin in bulk powder form within a topical formulation to treat Stasis dermatitis.

Purpose

To develop and validate a simple, accurate, reliable, sensitive and robust UV spectrophotometer technique for the simultaneous measurement of rutin and curcumin in accordance with ICH Guidelines.

Materials and Methods

To estimate Rutin and Curcumin simultaneously, a simple double-beam UV spectrophotometer method was developed. Methanol was used as the solvent to create the ideal conditions for the drug’s analysis.

Results

The optimal absorption wavelengths were identified at 257 nm for Rutin and 422 nm for Curcumin, representing their respective maximum absorbance peaks. The method showed a linear response over the concentration ranges of 4-20 μg/mL for Rutin and 1-5 μg/mL for Curcumin. Both analytes demonstrated a linear regression coefficient of 0.991, indicating a strong correlation between concentration and absorbance. The method was validated according to ICH Q2(R1) guidelines, including various parameters such as Linearity, Precision, Repeatability, Limit of Detection (LOD), Limit of Quantification (LOQ), Robustness, and Ruggedness. All validation results fell within the acceptance criteria, affirming the reliability and suitability of the method for quantitative analysis of Rutin and Curcumin. Thus, the study concludes that the developed method is novel, simple, selective, specific and precise for the simultaneous determination of Rutin and Curcumin in bulk powder samples.

Conclusion

The method demonstrates selectivity, specificity, precision, accuracy, ruggedness and robustness, facilitating its utility for the routine assessment of Rutin and Curcumin in both bulk substances and pharmaceutical formulations.