HPTLC Method for The Estimation of Aripiprazole From Tablet Formulation

A. Suganthi, P. Ravimathi*, Sapna Shrikumar, and T.K. Ravi.

College of Pharmacy, Sri Ramakrishna Institute of Paramedical Sciences, Coimbatore
– 44.

P. Ravimathi

A simple, fast, specific and precise High Performance Thin Layer Chromatographic
Method (HPTLC) has been developed for estimation of Aripiprazole in tablet dosage
form.

The stationary phase silica gel G60F₂₅₄ was selected for separation
and the sample was developed using a mixture of ethyl acetate: methanol in the
ratio 10.5: 0.5 v/v as mobile phase. Quantification was carried out at 260 nm
photometrically. The R_f value of Aripiprazole was found to be 0.25
± 0.02. Linearity was found to be in the concentration range of 200 to 1000
ng/spot of Aripiprazole and the correlation coefficient value is 0.9992. The
results of analysis were validated in terms of accuracy and precision. The LOD
was found to be 50ng/spot, LOD as 100 ng/spot and stability studies were made. 
The proposed HPTLC method provides a faster and cost effective quantitative
control for routine analysis of Aripiprazole in its formulation

* Presenting author

INTRODUCTION:

Aripiprazole is chemically a quinolinone derivative, used as an anti-psychotic
agent^1,2. Chemically, Aripiprazole is known as 7-[4-[4-(dichlorophenyl)piperizin-1-yl]-3,4-dihydroquinolinone.

Literature survey showed no HPTLC method for the estimation of Aripiprazole in tablet formulation. However, few analytical methods have so far been reported^4-6 for its determination. Most of this methods report the estimation of aripiprazole from tablet the biological samples particularly from plasma. Hence this paper reports a simple, precise, rapid and cost effective HPTLC method for the estimation of Aripiprazole in its formulation.

MATERIALS AND METHODS:

A CAMAG TLC system comprising of a Linomat-5 applicator and CAMAG TLC scanner
and single pan balance of Shimadzu model was used, for the present study.

Stationary phase used was silica gel G60F₂₅₄, 20x10 cm TLC plate, the mobile phase used was Ethyl acetate: methanol (10.5: 0.5 v/v). The plates were developed in a CAMAG twin trough glass chamber (20 x 10 cm) by ascending method. Distance of solvent front 85 mm, band length 6mm, slit dimension 5.00 x 0.45 mm and detection wavelength 260 nm were used for the present study.

PROCEDURE:

Accurately weighed 10 mg of Aripiprazole, dissolved in methanol and the volume
was made up to 100 ml with same (100 mg/ml). This was used as stock solution.
Varying volumes from 2 to 10 ml of standard stock solution were spotted on precoated
TLC plates using Linomat 5 applicator, plates were developed and scanned using
CAMAG TLC scanner 3. The peak areas and R_f values were noted and
a calibration graph was plotted [peak area Vs concentration (ng/spot)].

About twenty tablets of each formulation were weighed accurately, powdered and quantity equivalent to 10 mg of Aripiprazole was dissolved in methanol and made up to the volume to 100 ml with methanol and filtered through whatmann filter paper. Aliquot (2, 4 and 6 ml) were spotted as sharp bands on the chromatoplate using Linomat-5 applicator. The plate was developed and the spots were scanned, peak areas were noted. The amount of Aripiprazole was calculated using the calibration graph, and the results are compiled in table I.

RESULTS AND DISCUSSION:

The developed method was validated as per ICH guidelines.  The observed
percentage recoveries were 101.385, 102.51 which shows that the method is free
from interference from excipients present in the formulation, as given in table
II.

The analysis of Aripiprazole in dosage forms by the developed HPTLC method resulted in good accuracy as in recovery studies. The estimated amount of Aripiprazole present in tablet was in good agreement with the percentage label claim (14.97 and 15.075 mg/tab). The proposed method can be used for routine analysis of Aripiprazole in pharmaceutical dosage forms.

CONCLUSION:

Considering the obtained data, it was possible to affirm that proposed method
was precise, fast, simple and suitable for the accurate determination of Aripiprazole
in bulk drug and tablet dosage forms.

REFERENCES:

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8. Sethi, P.D., HPTLC – Quantitative Analysis of Pharmaceutical Formulation.,
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   TABLES

 Table 1: Result of Analysis and % Recovery of Aripiprazole

* Average of 6 readings

 Table II: Results of Method Validation Experiments of Aripiprazole

Solvent System: - Ethyl acetete: methanol (10.5: 0.5 v/v)