Method Development and Validation for Estimation of Curcumin in Fabricated Nano-Sized Formulation: Inter-Laboratory Comparison, Capability and Statistical Analysis
Objective: Current work was designed to develop a simple, rapid, and cost effective spectrophotometric method for the determination of curcumin in fabricated and marketed nano-sized formulation. Method: Methanol was optimized as solvent and further spectrophotometric detection was carried at analytical wavelength i.e. 421 nm. Method was further validated as per International conference on Harmonisation (ICH) guidelines for linearity, specificity, accuracy, precision; ruggedness and robustness. Results: The concentration of curcumin over range of 1-10 μg/ml obeys Beers law with a correlation coefficient of 0.999. Accuracy was raging from 99.06 to 99.72 %. Percent Recovery estimated was found to be 99.40 ± 0.330. The limit of detection (LOD) and limit of quantification (LOQ) was found to be 0.08 μg/ml and 0.26 μg/ml respectively. Shapiro-Wilk test (P = 0.7323) and Shapiro-Francia test (W’ = 0.9815; P= 0.8561) accept the normality of data. Bland-Altman plot revealed an acceptable repeatability coefficient. Youden Plot demonstrated the excellent inter-laboratory reproducibility and it was used to identify Random and total errors. Control charts like Levey-Jennings chart, X- chart and MR chart showed that method is under statistical control. Whereas, CUSUM chart revealed about targetability of the method. Capability analysis demonstrated greater values of Cp (1.18) and Cpk (1.08) than 1, indicating the capability of method to analyze the samples accurately and consistently with minimum variation. Conclusion: Validation report demonstrated that common excipients from commercial formulations do not interfere with the proposed method, hence can be applied in regular laboratory analysis. Statistical analysis showed good precision of proposed method.