Application of QbD Approach to Development and Validation of a Novel UV- Spectrophotometric Method for Quantitative Estimation of Quetiapine Fumarate in Bulk and Pharmaceutical Formulation (Tablets)
Journal Title: Saudi Journal of Medical and Pharmaceutical Sciences - Year 2018, Vol 4, Issue 2
Abstract
Abstract:Stability Indicating UV-spectrophotometric analytical method validation for the estimation of Quetiapine fumarate have already been reported, but no studies reported so far include the application of Analytical Quality by Design (AQbD) concept to the development of a comprehensive analytical UV-method for the analysis of model drug (Quetiapine fumatrate). In the present work, a simple, economic and sensitive UV spectrophotometric method has been developed using AQbD approach for the quantitative estimation of Quetiapine fumarate in bulk and pharmaceutical dosage forms i.e. tablets. The estimation of drug was done at 242 nm in simulated nasal fluid (SNF) using UV-Visible double beam spectrophotometer. In the developed method, linearity over the concentration range of 4-24μg/ml of QP was observed and was found in agreement of Beer’s law. The linear regression was found to be 0.999. The results of analysis have been validated statistically and recovery studies confirmed the accuracy of the proposed method. The precision (intra-day & inter-day) of method was found within limits (RSD < 2%). The sensitivity of the method was assessed by determining limit of detection and limit of quantification. The method was found to be repeatable as well as robust. The percentage of QP in the marketed formulation (Qutipin-100) was observed to be 99.46%. It could be concluded from the results obtained in the present investigation that the method for estimation of Quetiapine fumarate in pure form and in pharmaceutical dosage form is simple, rapid, accurate, precise and economical and can be used, successfully, in the quality control of pharmaceutical formulations and other routine laboratory analysis. Keywords:Quetiapine fumarate, Analytical Quality by Design (AQbD), Simulated Nasal Fluid (SNF), UV-Spectrophotometer, Validation.
Authors and Affiliations
Navjeet Kaur, Charanjit Kaur
Keywords
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