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Abstract

DEVELOPMENT OF HPLC METHOD FOR MECLIZINE HYDROCHLORIDE BY USING QUALITY BY DESIGN APPROACH

Ashwini D. Pote*, Kalyani B. Wagh, Sachin G. Dhandore and Rajendra Khedkar

ABSTRACT

Quality by Design refers to the achievement of certain predictable quality with desired and predetermined specification. Implementation of QbD helps to develop rugged and robust method which helps to comply with ICH guideline hence for that reason pharmaceutical industries are adopting this concept of QbD. Meclizine is an antihistamine that reduces the effects of natural chemical histamine in the body. Meclizine is used to treat or prevent nausea, vomiting, and dizziness caused by motion sickness. It is also used to treat symptoms of vertigo (dizziness or spinning sensation) caused by disease that affects inner ear. Present work will be carried out for development of Meclizin hydrochloride on HPLC. Selection of solvent is based on literature survey and chemical nature of the drug. Once the general HPLC method develops, QbD Approach will be applying for the same, we get the optimized HPLC method by using the Design of Experiment software.

Keywords: HPLC, QbD Approach, Meclizin hydrochloride.


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