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Ph.D.
(Pharmacy)
DEVELOPMENT AND VALIDATION OF ANALYTICAL METHODS FOR
DETERMINATION OF NEWER ANTI-PSYCHOTIC DRUGS IN
BULK AND THEIR COMBINATION USING QbD APPROACHES
Ph.D. Scholar : Patel Megha Rushikesh
Research Supervisor : Dr. Paresh U. Patel

Regi. No.: 19276011003
Abstract :
Present work comprises of three combinations, which begins with introductory part and
literature survey.
In first combination Olanzapine and Aripiprazole , perform four different methods likedual
wavelength method, stability indicating HPTLC method,HPLC method and quality by
design method for determination of anti psychotic drug which implies the techniques are
accurate,reliable, exact and specific.

In second combination Paroxetine HCl and Etizolam, perform three methods which
include simultaneous estimation, Chemometric method and statistically comparison by
ANOVA method. The developed methods are beneficial in terms of ease of performing
and reduced cost of the analysis for routine analysis,quality control of mixture and
commercial preparation containing these two drugs.
In third combination Pimavanserine and Risperidone perform stability indicating RP-HPLC
method. The approach is straightforward, accurate, and exact and it responds linearly
within the specified range. These qualities indicate the use of the suggested
methodologies in routine and quality control analysis without interference from widely
used excipients and additives, based on the observation and results obtained in the
validation research as proposed by ICH.
Key words: Olanzapine, Aripiprazole, Paroxetine HCl, Etizolam, Pimavanserine,
Risperidone, reverse phase HPLC method, HPTLC method, Chemometric method.

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