ファーマシューティカ アナリティカ アクタ

概要

Novel Statistically Designed Qbd Methodology for Quantitative Analysis of Nisoldipine in Pharmaceutical Dosage Forms

Permender R, Anjoo K and Shabir S

The objective of the study was to develop superlative reproducible spectrophotometric estimation process of Nislodipine via BCG (Bromocresol green) solution using novel statistically Taguchi via factorial design methodology. Primarily, an L9 design array was experimented to find significant analytical variables and optimize their(s) best levels keeping drug amount constant. Additionally factorial i.e. Box-Behnken design (BBD) of better factors (X, Y & Z) levels at positive, null and negative spaces responses (R=absorbance) was studied to found better to best level. Moreover, polynomial quadratic equations for two and three dimensional models were designed to predict the best significant independent levels. The selected variable responses were statistically evaluated using ANOVA and showed correlation coefficient (r2=0.999) followed by good Beer’s (5-40 μg/ml) range at maximum absorption wavelength (420 nm) and was validated according to ICH guidelines. This robust novel statistically designed strategy can be considered as quality by design (QbD) quantitative methodology for Nisoldipine estimation in pharmaceutical’s.