Development and Validation of Stability Indicating UV-Visible Spectrophotometric Method for Simultaneous Estimation of Neem (Azadirachtin) and Curcumin in Pharmaceutical Tablet Dosage Form

Abstract

The objective of the present study is to develop and validate a stability indicating UV-Visible spectrophotometric method for the simultaneous estimation of Azadirachtin and Curcumin complex in combined pharmaceutical tablet dosage form. The present method is based on simultaneous equation method based on measurement of absorbance at two wavelengths, 271nm and 421nm, λmax of Azadirachtin and Curcumin complex. The purposed method was validated statistically for linearity, accuracy, precision, repeatability, ruggedness, sensitivity as per international conference on harmonisation (ICH) guidelines. The drug substance was exposed to forced degradation studies. The method obeyed Beer Lambert’s law in the concentration range of 50-450 μg/ml for Azadirachtin and 200-1000 μg/ml for Curcumin complex. The high values of correlation coefficient (R2) indicated good linearity of calibration curve. % RSD associated with all the validation parameters were < 2 % confirming accuracy and precision. There were no significant changes in absorbance after performing the forced degradation studies. The % age of Azadirachtin and Curcumin complex was found to be 98.80 ± 0.92 and 95.80 ± 0.00 respectively. The proposed method can be successfully applied to the the routine in-vitro dissolution analysis of Azadirachtin and Curcumin complex in its combined pharmaceutical tablet formulations.