45
Int. J. Pharm. Med. & Bio. Sc. 2013 Kareti Srinivasa Rao et al., 2013
RP-HPLC METHOD FOR THE ESTIMATION
OF ZIPRASIDONE
Kareti Srinivasa Rao
1*
, Nargesh Kumar Keshar
1
,
Prasenjit Roy Choudhury
1
, M E Bhanoji Rao
1
and Ajay Kumar Pattnaik
2
Research Paper
A simple, sensitive, accurate and precise LC assay method was developed for the quantitative
determination of Ziprasidone Hydrochloride (ZSH) in pharmaceutical dosage form.
Chromatographic separation was achieved by use of Lichrospher RP-18 column (250 × 4.0
mm, 5 m), using 20 mM ammonium acetate (pH adjusted to 3.0 with orthophosphoric acid) and
methanol (30:70 %v/v) as mobile phase at 25
o
C. The described method was linear over a range
of 1-500 g mL-1 for determination of ZSH (r= 0.9998). F-test and t-test at 95% confidence level
were used to check the intermediate precision data obtained under different experimental setups;
the calculated value was found to be less than critical value. The developed method was found
to be simple, specific, robust, linear, precise, and accurate for the determination of ZSH in
pharmaceutical formulations.
Keywords: Ziprasidone Hydrochloride, validation, assay, recovery studies.
*Corresponding Author: K. Srinivasa Rao, ksrao108@gmail.com
INTRODUCTION
Ziprasidone, 5-[2-[4-(1, 2-benzisothiazol-3.2-yl)-
1-piperazinyl] ethyl]-6- chloro-1,3.2-dihydro-2 H -
indol-2-one
,
(ZSH) (Figure 1) is an antipsychotic
agent that is chemically unrelated to phenothiazine
or butyrophenone antipsychotic agents. ZSH ‘s
unique pharmacology offers advantages in the
areas of antipsychotic-induced weight gain and
possibly the treatment of depressive symptoms
in patients with schizophrenia or schizoaffective
disorder. The efficacy of ZSH in schizophrenia is
primarily attributable to dopamine (i.e, D
2
) and
serotonin (specifically 5HT
2
A) receptor
ISSN 2278 – 5221 www.ijpmbs.com
Vol. 2, No. 1, January 2013
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Int. J. Pharm. Med. & Bio. Sc. 2013
1
Roland Institute of Pharmaceutical Sciences, Berhampur -760010, Orissa, India.
2
Khallikote College, Berhampur, Orissa, India.
antagonism, which contributes to its more
favorable effect on weight gain than clozapine,
olanzapine, and risperidone (Sweetman, 2009).
Literature survey revealed that several
analytical methods were reported for the
determination of ZSH in biological matrices,
including; liquid chromatography-tandem mass
spectrometry (Zhang et al., 2008; Zhang et al.,
2007; Zhang et al ., 2007; Al-Dirbashi et al ., 2006),
liquid chromatography/UV detection (Zhang et al.,
2007), liquid chromatography/fluorescence
detection (Suckow et al., 2004). Few analytical