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Quality by design approach to method development and validation of Secnidazole

Volume No : (2019) Volume: 07 Issue : 34 Year : 2019 Page No: 45-60

Authors : Komal Korade, Nanasaheb Dharbale, Vijayalaxmi Chavan

Abstract :

Aim: The purpose of research work was to develop suitable UV spectrophotometric method of Secnidazole, study the risk assessment associated critical quality attributes (CQA), apply quality by design (QbD) principles to develop reverse phase high performance liquid chromatography (RP-HPLC) method for Secnidazole, and explore the applicability of the method for routine analysis of Secnidazole in tablet dosage form.

Materials and Methods: RP-HPLC method was developed by implementing QbD methodology with mobile phase methanol:water (70:30% v/v). The flow rate used was 1.0 ml/min and UV detection was carried out at 310 nm. The retention time for Secnidazole was found to be 3.21 min. The study was done using Box-Behnken response
surface design. In this study, interaction of three factors; mobile phase concentration, flow rate, and wavelength, varies at three levels. Effect of such critical process parameter on CQA of the method was studied. Responses in terms of retention times and number of theoretical plates and asymmetry factor (tailing factor) were evaluated throughout all the runs in design. The QbD approach has been successfully used to develop HPLC method for Secnidazole.

Results: From the results of validation parameters, we concluded that the method is accurate, precise, simple, and robust. From the results of percentage recovery, we concluded that the method developed is useful for the estimation of the Secnidazole in marketed formulation. Moreover, the lower solvent consumption along with the short analytical run time of 7 min leads to a cost-effective and environment-friendly chromatographic procedure.

Conclusion: Thus, the proposed methodology is rapid, selective, requires a simple sample preparation procedure, and represents a good procedure for the estimation of Secnidazole.

Keywords: Spectrophotometric, Box-Behnken, quality by design methodology, environmentfriendly chromatographic

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