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Visible Spectrophotometric Method for the Determination


of Aripiprazole in Tablets
R. JAIN, S. K. KASHAW*, RISHAB JAIN, P. MISHRA AND D. V. KOHLI
Pharmaceutical Chemistry Division, Department of Pharmaceutical Sciences, Dr. H. S. Gour University,
Sagar - 470 003, India

Jain, et al.: Spectrophotometric Method for Aripiprazole

A simple, accurate and economic spectrophotometric method for the determination of aripiprazole in tablet
formulation is proposed. In the present method acidic solution of the aripiprazole formed colored ion-association
complexes with bromocresol green, soluble in chloroform. Yellowish orange chromogen showed λmax at 414 nm
and obeyed Beer’s law in the concentration range of 10-60 µg/ml. Statistical analysis and recovery studies validated
the method. The proposed method is rapid, precise and accurate and can be applied for the routine estimation of
aripiprazole in the laboratory.

Key words: Aripiprazole, UV/Vis spectrophotometry

Aripiprazole (C23H27Cl2N3O2; molecular weight=448.39) management of schizophrenia and is also under


is chemically 7-4-[4-(2,3-dichlorophenyl)-1-piprazenyl] investigation for bipolar disorder[1-2]. Literature survey
butoxy]-3,4-dihydro-(1H)-quinolinone (fig. 1). It revealed that several methods including HPLC with
is an atypical antipsychotic drug with serotonin 5- column switching and spectrophotometric detection[3]
HT1A-receptor partial agonist and 5HT2A-receptor and reverse phase HPLC methods have been reported
antagonist properties as well as being a partial for the estimation of aripiprazole. Till date no UV/
agonist at dopamine D2 receptors. It is used in the Vis spectrophotometric method for the estimation of
aripiprazole is reported. Therefore the present paper
*Address for correspondence reports a simple and sensitive spectrophotometric
E-mail: sushilkashaw@gmail.com method for the estimation of aripiprazole in tablets.
74 Indian Journal of Pharmaceutical Sciences January - February 2011
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TABLE 1: OPTICAL CHARACTERISTICS AND


REGRESSION ANALYSIS OF ARIPIPRAZOLE
Parameters Values
max (nm) 414
Beer’s Law Limit (µg/ml) 10-60
Molar absorptivity (L/mol.cm)* 6.5018´104
Sandell’s sensitivity 0.0689
(µg/cm2x0.001 absorbance unit)
Fig. 1: Structure of aripiprazole Regression equation y = 0.0125x +0.0539
Slope (a) 0.0125
A GBC Cintra-10 double beam UV/Vis Intercept (b) 0.0539
spectrophotometer (Australia) equipped with 10 Correlation coefficient (r) 0.9968
*Average of six determinations.
mm matched quartz cells was used in the present
investigation. The spectrophotometer was run at a
spectral band width of 5 nm with a scan speed of
24~1400 nm/min. Methanol AR grade, Bromocresol
green dye and chloroform AR grade (Qualigens,
Mumbai) was used in the present study. Pure
aripiprazole as gift sample was obtained from M/s
Torrent Pharmaceuticals Ltd, Ahmdebad. All other
chemicals used were of analytical grade.

A stock solution (S) of aripiprazole was prepared


by dissolving 10 mg (accurately weighed) of the
drug in 1 ml of concentrated sulphuric acid and
finally the volume was made up to 10 ml with Fig. 2: Aripiprazole scanned in visible range using BCG (in 0.1N HCl)
distilled water (1000 µg/ml). Stock solution (S) was
further diluted with distilled water to get a working Alkem Laboratory Ltd.) were purchased from
standard solution (100 µg/ml) for spectrophotometric local pharmacy. Average weight of a tablet was
estimation. The stock solution was suitably diluted calculated by weighing 20 tablets. Tablets were
to produce solution of concentration 10 µg/ml, powdered finely and powder equivalent to 100 mg
this working solution was scanned in the entire of aripiprazole was extracted with 10 ml portion of
UV/Vis range (200-800 nm) to determine the λmax concentrated sulphuric acid, filtered and the volume
(fig. 2). Different aliquots (1.0, 2.0…6.0 ml) of made up to 100 ml with water (1000 mg/ml).
working standard solution was taken in to a series of Aliquots of this solution were treated as mentioned
10 ml volumetric flasks, and to this 2 ml of buffer for standard. The above tablet powder solution was
solution and 2 ml of 0.5% bromocresol green dye then suitably diluted to obtain concentration range of
solution were added and volume were made up with 10-60 µg/ml of aripiprazole. Absorbances were taken
distilled water in each volumetric flask to prepare a and concentrations of aripiprazole were determined
series of concentration between 10-60 µg/ml. Poured using the calibration curve. Finally calculations
in different separating funnels and the solutions were made with the dilution factor to find out the
were extracted with chloroform (successively) concentration of the drug in tablets. The experiments
4´2 ml. Separated organic layer were collected in were repeated six times to check its reproducibility.
10 ml volumetric flask and volume was made up To study accuracy, reproducibility and precision
with chloroform. The absorbance of the yellowish of the method, recovery studies were carried out
chromogen was measured at 414 nm, against a by adding known amount of pure drugs to the
reagent blank and calibration curve was plotted in 10 analyzed sample of tablet powder and mixture was
to 60 µg/ml concentration range. reanalyzed for the drug content using the proposed
method. Results of recovery were found to be
Three commercial formulations, Arip-MT satisfactory. The proposed method for determination
15 (M/s Torrent Pharmaceuticals Ltd.) Asprito of aripiprazole showed molar absorptivity
(Intas Pharmaceuticals Ltd.) and Arive (M/s of 6.5018´10 4 l/mol´cm. Linear regression of
January - February 2011 Indian Journal of Pharmaceutical Sciences 75
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TABLE 2: STATISTICAL ANALYSIS OF ARIPIPRAZOLE


Brand name Label claim Amount Found SD* COV* SE* ‘t’ cal* ‘t’ the*
(mg/tab) (mg/tab)*
ARIP-MT 15 15 15.01±0.01 0.0182 0.1214 0.0074 0.6856 3.365
ASPRITO 10 10.01±0.01 0.0126 0.1257 0.0051 1.7712
ARIVE 20 20.03±0.02 0.0279 0.1397 0.0114 2.7391
*Average of six determinations. *Theoretical‘t’ values were calculated at 95% confidence level with (n-1) degrees of freedom ‘t’ (0.025, 5) = 3.365. SD = Standard
deviation, COV = Coefficient of variance and SE = Standard error.

TABLE 3: RECOVERY STUDIES OF ARIPIPRAZOLE were reanalyzed by the proposed methods. The
Brand name % Recovery ± S.D* percentage recovery was close to 100% for both
ARIP-MT 15 101.62±0.16 methods. The results are summarized in Table 2. The
ASPRITO 100.75±0.02 reproducibility, repeatability, and accuracy of this
ARIVE 100.38±0.01
method were found to be good evidenced by low
*Average of six determinations
standard deviation.

absorbance on concentration obtained the equation ACKNOWLEDGEMENTS


y = 0.0125x + 0.0539 with a correlation coefficient
(r) of 0.9968 (Table 1). Statistical analysis of The authors wish to thank Torrent pharmaceuticals ltd.,
commercial formulations is presented in Table 2. Ahemdebad, for providing gift sample of aripiprazole. One
The recovery experiments indicated the absence of the authors (RJ) thanks UGC, New Delhi for providing
of interference from the commonly encountered financial assistance.
pharmaceutical additives and excipients (Table 3).
REFERENCES
Significantly low values of standard deviation,
standard error and coefficient of variation indicates 1. Sweetman SC. Martindale: The Complete Drug Reference. 34th ed.
London: Royal Pharmaceutical Society of Great Britain; 2005. p. 671.1.
the precision of the proposed method. These values 2. Budavari S. The Merck Index. 13th ed. Whitehouse Station, NJ: Merck
are compared with the theoretical values of 100 and Co., Inc.; 2001. p. 791.
percent by means of unpaired students ‘t’ test 3. Kirchherr H, Kuhn-Velten WN. Quantitative determination of forty-eight
antidepressants and antipsychotics in human serum by HPLC tandem
(Table 2). As the calculated ‘t’ values were less than mass spectrometry: A multi-level, single-sample approach. J Chromatogr
theoretical ‘t’ values, it is calculated that the results B Analyt Technol Biomed Life Sci 2005;51:1718.
of analysis were in good agreement for each brand
of tablet. To test the accuracy and reproducibility Accepted 14 January 2011
of the proposed method, recovery experiments were Revised 23 October 2010
performed by adding known amount of pure drug Received 17 February 2010
to previously analyzed samples, and these samples Indian J. Pharm. Sci., 2011, 73 (1): 74-76

Leucocyte Variation, an Insight of Host Defenses During


Hymenolepiasis and Restoration with Praziquantel
J. PARVATHI* AND ARUNA KAREMUNGIKAR
PG Department of Zoology, Vivek Vardhini College, Jambagh, Hyderabad - 500 095, India

Parvathi and Karemungikar: Leucocyte Variation and Host Defenses in Hymenolepiasis

Haematological studies in helminthiasis reveal drastic alterations in the white blood cells (leucocytes), and its
various components like neutrophils, lymphocytes, monocytes and eosinophils. The use of proper anthelmintic

*Address for correspondence


E-mail: saip_jayanthi@yahoo.co.in

76 Indian Journal of Pharmaceutical Sciences January - February 2011

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