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A Simple and Rapid Spectrophotometric Determination of Aripiprazole in Pharmaceutical Dosage Form

Samiran Dey 1*, Nitesh Chauhan2,Dr. P. Malairajan3, R. Murugan4 , Rakhal Chandra Das5 ,Shafique Ahmad6
  1. Department of Pharmaceutical Analysis, Innovative College of Pharmacy, Greater Noida, Uttar Pradesh, India
  2. Department of Pharmaceutics, KIET School of Pharmacy, Ghaziabad, U.P
  3. Department of Pharmaceutical Analysis, Karpagam College of Pharmacy, Coimbatore, India
  4. Department of Pharmacology, C. U. Shah College of Pharmacy & Research, Wadhwan, India
  5. Department of Pharmacology, MRR College of B.Pharmacy, Krishna, Vijayawada, Andhra Pradesh, India
  6. Department of Pharmacology, Jamia Hamdard, New Delhi
 
Corresponding Author: Samiran Dey ,Department of Pharmaceutical Analysis, Innovative College of Pharmacy, Plot No ? 6, Knowledge Park -2, Greater Noida, Ph. No - 0120-5524033, 55224035, Tel: 09654838870, E-mail: dey.samiran@gmail.com
 
Received: 23 October 2010 Accepted: 25 January 2011
 
Citation:Samiran Dey, Nitesh Chauhan, Dr. P. Malairajan, R. Murugan, Rakhal Chandra Das, Shafique Ahmad ?A Simple And Rapid Spectrophotometric Determination Of Aripiprazole In PharmaceuticalDosage Form?, Int. J. Drug Dev.& Res., Jan-March 2011, 3(1): 205-208. doi: doi number
 
Copyright: © 2010 IJDDR, Samiran Dey et al. This is an open access paper distributed under the copyright agreement with Serials Publication, which permits unrestricted use, distribution, and eproduction in any medium, provided the original work is properly cited.
 
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Abstract

A new simple, sensitive, spectrophotometric method in ultraviolet region for the determination of aripiprazole in bulk and pharmaceutical dosage forms was developed. Spectroscopic determination was carried out at an absorption maximum of 256 nm using 95% ethanol as solvent. In the UV spectroscopic method linearity over the concentration range of aripiprazole was found to be 5 ? 30 µg/ml with a correlation coefficient 0.9995. Results of the analyses were validated statistically and by recovery studies. The developed method was found to be precise, selective and rapid for the estimation of aripiprazole in solid dosage form.



 

Introduction

 
Aripiprazole is chemically 7-[4-[4-(2,3-dichloro) phenyl piprazine –1- yl] butoxy]-3,4-dihydro-1Hquinolin- 2-one and the molecular formula is C23H27Cl2N3O2. It is the sixth and most recent second- generation antipsychotic agent, used in the treatment of acute, manic and mixed episodes associated with bipolar disorder [1, 2]. Aripiprazole appears to mediate its antipsychotic effect primarily by partial agonism at the D2 receptor that has been shown to modulate dopaminergic activity in areas where activity may be high or low. It shows partial agonism at the 5-HT1A receptor and antagonist profile at the 5- HT2A receptor [3]. Only a few authors have described the validation methods for aripiprazole among which UV and HPLC methods have been developed for the drug in rat plasma, human plasma and pharmaceutical formulations [4, 5, 6, 7]. As these methods are expensive and not reproducible, we have made an attempt to develop a more precise, simple and economical spectrophotometric method with greater precision, accuracy and sensitivity for the analysis of aripiprazole in bulk and dosage forms.
 

EXPERMENTAL

 

Materials

 
Aripiprazole bulk drug (Orchid Health Care, Chennai, India) and ethyl alcohol (S.D. Fine Chemicals Ltd., Mumbai, INDIA) were used for the study.
 

METHOD

 

Selection of wavelength

 
The drug was found to have a maximum absorbance at 255.92 nm in ethyl alcohol and hence this λmax was selected for further studies (Figure 1).
 

Standard stock solution

 
A stock solution of 1000 µg/ml of aripiprazole was prepared freshly by dissolving 10.0000 mg of the drug in 10 ml of ethyl alcohol.
 

Sample solution

 
For the analysis of aripiprazole in tablets, a commercial brand, Arip-MT (Torrent Pharmaceuticals Ltd., Ahmedabad, India) of 10 mg strength was taken. Twenty tablets were weighed and powdered. The tablet powder equivalent to 10 mg of aripiprazole was weighed accurately and dissolved in 10 ml of ethyl alcohol. The solution was filtered through Whatman filter paper number 40 and the filtrate was diluted to 100 ml with water. An aliquot corresponding to 10 µg/ml was analyzed by the proposed method.
 

Procedure for calibration and assay

 
The stock solution was diluted in such a way with double distilled water to get the required concentrations, 5, 10, 15, 20, 25 or 30 µg/ml. The absorbance was measured at 255.92 nm using a UV visible spectrophotometer (Perkin Elmer, Massachusetts 02451 USA) lambda 25 model with 1 cm matched quartz cell against ethyl alcohol as a blank (Figures 2 & 3).
 

Recovery study

 
Recovery experiments were carried out to study the accuracy, reproducibility and precision of the proposed method. Percentage recovery was calculated from the amount of the drug found (Table 1 & 2).
 

Statistical Analysis

 
Statistical analyses were carried out using Graph pad Prism 2.01 statistical software (Graph pad software, San Diego, CA, USA). Experiments were repeated for confirmation of results and to determine its reproducibility. The data of each experiment did not differ from each other significantly and hence all the data have been combined and means calculated.
 

RESULTS AND DISCUSSION

 
The proposed method for the determination of aripiprazole in solid dosage form was found to be precise, selective, rapid and economical. Aripiprazole exhibited maximum absorption at 255.92 nm and obeyed Beer’s law in the concentration range of 5-30 µg/ml. the proposed method for the determination of aripiprazole showed molar absorptivity of 0.74023 x 10-4, linear regression Y = 0.031X + 0.0156 with a correlation coefficient(r2) of 0.9995 (Figure 3). Similar results were obtained for granisetron hydrochloride, famiclovir, gatifloxacin in tablets and bulk dosage forms. A relative standard deviation of 0.330 % was observed on analysis of six replicate samples. Kumar et al., (2007) have described spectrophotometric, RP-HPLC and solvation (acetonitrile and 0.1 M HCl for dissolution and dilution respectively) methods for determination of aripiprazole. Our studies revealed a recovery percentage of 100.12 ± 0.52 %, which indicates that the developed method was simple, rapid and precise. Similar results were obtained in the studies of Kumar et al (2007). But most important of all, our method proves to be more economical than the published standard methods.
 

ACKNOWLEDGEMENT

 
The authors are grateful to Orchid Pharmaceuticals Private Limited, Chennai for providing authentic sample of aripiprazole, S.D. Fine Chemicals Ltd., Mumbai, India for providing solvents and reagents and Shree Samanvay Institute of Pharmaceutical Education and Research, India for providing necessary facilities and encouragement.
 

Conflict of Interest

 
NIL
 

Source of Support

 
NONE
 

Tables at a glance

Table icon Table icon
Table 1 Table 2
 

Figures at a glance

Figure Figure Figure
Figure 1 Figure 2 Figure 3
 

References








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