DEVELOPMENT OF A UPLC ASSAY METHOD OF DANAZOL USING QbD APPROACH

Mrunalini Kulkarni and Vikas Nawathye
In: International Journal of Pharma and Bio Sciences · 2015 · W2505582341
article OA: closed CC0 ⤵ 1 in-corpus citation Metadata only
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A stability-indicating ultra performance liquid chromatographic method for Danazol estimation was developed using a Quality by Design approach, demonstrating excellent resolution of degradation products.

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Abstract

A novel stability-indicating reverse phase ultra performance liquid chromatographic method was developed for the estimation of Danazol. To establish specificity and to develop a stability indicating method, Danazol was subjected to the stress conditions like oxidative, acid, base, hydrolytic, thermal and photolytic degradation. Chromatographic separation was achieved on ultra performance liquid chromatography (UPLC) by quality by design (QbD) approach. The eluted compounds were monitored at 270 nm. All the degradation products were well resolved from the main peak, proving the stability-indicating power of the method. The developed method was validated as per International Conference on Harmonization (ICH) guidelines with respect to specificity, precision, linearity, accuracy, robustness and ruggedness.

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