Validated UV Spectroscopic Method for the Quantitative Analysis ofNigella sativa Extract

Introduction: As per International Council for Harmonisation (ICH) guidelines for analytical method development and validation, a UV spectrophotometric method was developed and validated for the quantitative determination of Nigella sativa extract. The method was simple, specific, accurate, and precise. Materials and Methods: The assessment of the present method includes various validation parameters, such as identification, linearity, range, precision, accuracy, robustness, and ruggedness. The objective was to design a reliable, economical, and efficient method suitable for routine analysis of Nigella sativa extract in quality control settings. Results: The developed analytical method showed a linear relationship over the concentration range of 200–1600 μg/mL, with a high R² (0.99), confirming its applicability for quantitative analysis. It is remarkably precise and accurate, as confirmed by very low %RSD values for repeatability and intermediate precision. Moreover, the recovery rates are within the acceptable range as per the ICH guidelines. A detection limit (LOD) of 107.16 μg/mL and a quantification limit (LOQ) of 324.74 μg/mL, were exhibited, which indicated good sensitivity of the method. Discussion: The proposed method demonstrated a clear and consistent relation between absorbance and concentration by exhibiting a remarkable linearity across 200–1600 μg/ml concentration ranges. The high correlation coefficient (R²) reflects that the method is highly sensitive and capable of accurately detecting and quantifying low analyte concentrations of Nigella sativa extract. The method also showed high precision and accuracy through low %RSD values for repeatability and intermediate precision, with recovery rates falling within acceptable limits as per ICH guidelines. The LoD (107.16 μg/mL) and LoQ (324.74 μg/mL) are well within the calibration range (200–1600 μg/mL), indicating good method sensitivity and reliability. Additionally, robustness and ruggedness studies affirmed the reliability of the proposed method under varied analytical conditions, featuring its suitability for diverse laboratory environments. conclusion: In conclusion, the UV spectrophotometric method developed in this study is simple, rapid, cost-effective, and highly reproducible. It serves as an ideal tool for the routine estimation of Nigella sativa extract, contributing to enhanced quality control and standardisation of herbal products in various pharmaceutical formulations. Conclusion: In conclusion, the UV spectrophotometric method developed in this study serves as an ideal tool for customary estimation of Nigella sativa extract. This method is simple, rapid, costeffective, and highly reproducible, contributing to enhanced quality control and standardisation of herbal products in various pharmaceutical formulations.