World Journal of
Pharmaceutical and Life Sciences

( An ISO 9001:2015 Certified International Journal )

An International Peer Reviewed Journal for Pharmaceutical and Life Sciences
An Official Publication of Society for Advance Healthcare Research (Reg. No. : 01/01/01/31674/16)
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Abstract

DEVELOPMENT AND OPTIMIZATION OF ERLOTINIB HYDROCHLORIDE ANALYTICAL METHOD BY USING QUALITY BY DESIGN APPROACH

Bandana Kumari*

ABSTRACT

A reversed-phase high performance liquid chromatographic (HPLC) technique for the determination of Erlotinib Hydrochloride has been optimized using analytical quality by design (QbD) approach. All the compounds are monitored with the photodiode array (PDA) detector at 336 nm. The experiments were conducted by changing the three different factor, that are pH, concentration of methanol and flow rate by using of a 23 factorial design space. The whole technique is developed as per International Council for Harmonization (ICH) guidelines. The proposed method is robust, sensitive, rapid and successful and helpful in the regions where regulatory agencies recommend HPLC analytical method.

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