Asian Journal of Pharmacy & Life Science, Vol. 1 (2), March-June, 2011 ISSN 2231 – 4423 --------------------------------------------------------------------------------------------------------------------- Simultaneously Estimation of Paracetamol, Aceclofenac and Rabeprazole in Tablet Dosage Form Using UV Spectroscopy
Mandhanya Mayank*, Dubey Nitin, Chaturvedi S.C., Jain D.K.
College of Pharmacy, IPS Academy, Rajendra Nagar, A.B. Road, Indore, India.
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ABSTRACT
Paracetamol {N- (4-hydroxyphenyl) acetamide} and Aceclofenac {2-[(2, 6-dichlorophenyl) amino] phenyl acetoxy acetic acid} are NSAIDs which acts by inhibiting the synthesis of prostaglandins. Rabeprazole {2-[(4-(3- methoxypropoxy)-3-methyl-pyridine–2-yl) Methylsulfinyl- 1H benzoimidazole} is an anti ulcer drug which is a proton pump inhibitor. No spectroscopic method has been reported for the Simultaneous estimation of Paracetamol, Aceclofenac and Rabeprazole in Combined Tablet Dosage Formulation. Hence simple, sensitive, reliable and rapid spectroscopic methods have been developed for the determination of paracetamol, aceclofenac and rabeprazole in combined tablet dosage form. Determinations were performed on Shimadzu UV-Visible double beam recording spectrophotometer (Model UV-1700). The linearity of paracetamol, aceclofenac and rabeprazole was found to be 3- 30µg/ml, 2-20 µ g/ml, and 2-20µg/ml respectively. The stability of the solution was found to be 72 hrs. The method was validated for accuracy, precision, repeatability as per ICH Guidelines. This method can be used commercially for routine estimation of various compounds in pharmaceutical dosage forms. Key-words – Paracetamol, aceclofenac, rabeprazole, multi-component, derivative spectroscopy, validation. ------------------------------------------------------------------------------------------------------------------------------------------ Corresponding Author’s E-mail: - mayankmandhanya@gmail.com Received: 27/05/11 Accepted: 12/07/11 113 Available online on www.ajpls.com Original Research Article
Asian Journal of Pharmacy & Life Science, Vol. 1 (2), March-June, 2011 ISSN 2231 – 4423 INTRODUCTION
appropriate absorbance, same stock solution were used
Combination of paracetamol (PCM), aceclofenac
to spike the concentration of RAB in mixed standard
(ACF) and rabeprazole (RAB), in the tablet dosage
analysis and analysis of commercial preparation and all
form is widely used as an analgesic. The official
the apparatus were calibrated before use.
monograph describes the procedure for individual assay
of PCM [1], [2] and ACF [3], where as RAB is not official
METHOD - I
in any pharmacopoeia. The IP (1996) and BP (2003)
Multi-component method -
both suggest titrimetric and UV spectrophotometric
Standard solutions:
assay method for PCM in bulk and tablet formulations.
Three stock solutions were prepared by dissolving 50,
Literature survey revealed that HPLC [4] , densitometric
10, and 1mg (spiked to 10 mg) of PCM RAB and RAB
[5] , spectrofluorimetric [6] and colorimetric [7] methods
in 100 ml of methanol respectively and again 1 mg of
have been reported for the estimation of ACF in
the above solution was taken and diluted up to 100 ml,
pharmaceutical dosage forms. Method for simultaneous
in this solution the concentration of RAB was spiked to
analysis of PCM and ACF by UV spectroscopy [8] and
10 times. Six mixed standards were prepared from the
RP-HPLC [9] has been reported. But no method was
stock solution with different concentration ranging from
reported on the combination of PCM, ACF and RAB.
5-30, 2-12 and 2-12 µg/ml of PCM ACF and RAB
In the present study, methods for simultaneous
respectively. All the mixed standard solutions were
quantification methodology of PCM, ACF and RAB in
scanned over the range of 390-190 nm in multi-
tablet by UV spectroscopy were developed and the
component mode using three sampling points 249, 276
developed methods were validated as per ICH
and 284 nm. These solutions were used to calculate the
linear dynamic range and for the relative quantification
MATERIALS AND METHODS Instrumental: Sample preparation:
Analysis were carried out on SHIMADZU UV 1601
Twenty tablets of Ace-Proxyvon (label claim as
UV-VIS spectrophotometer, a double beam high speed
containing 500 mg of PCM, 100 mg of ACF and 10 mg
scanning spectrophotometer with a photomultiplier tube
of RAB) were weighed, crushed and powder equivalent
detector and having spectral bandwidth of 1nm (
to 50 mg of PCM, 10 mg of ACF and 1 mg RAB (tablet
contains 500 mg PCM, 100 mg ACF and 10 mg RAB) was extracted four time with 20 ml methanol each time
Chemicals and reagents: PCM, ACF and RAB were received as gratis sample by
and volume was made up to 100 ml. residue was
Ipca Laboratories Ltd., India, Commercial tablets
filtered using Whatman grade filter paper. The filtrate
containing PCM (500mg), ACF (100mg), and RAB
was further diluted and concentration of Rabeprazole
(10mg) Ace-Proxyvon (Wockhardt Pharmaceuticals
was spiked 10 times to get final concentration of all
Ltd, India) were used for study. All the chemicals used
three drugs in the linearity range. Absorbance of tablet
were of analytical grade (E. Merck, India.)
preparation was noted at the selected wavelengths.
Low concentration of RAB in the dosage necessitate the
requirement of its spiking (10 times) to produce
METHOD II - Derivative spectroscopy - 114 Available online on www.ajpls.com Original Research Article
Asian Journal of Pharmacy & Life Science, Vol. 1 (2), March-June, 2011 ISSN 2231 – 4423 Standard solutions:
was spiked 10 times to get final concentration of all
Stock solution of PCM (100 µg/ml) was prepared by
three drugs in the linearity range. Resulting solutions
dissolving 100mg of PCM in 75 ml of methanol and
were scanned over a range of 390-190 nm and the
the volume was made up to the mark with methanol
resulting absorbance spectra were converted to first
(1000 µg/ml) . 10 ml of the above solution was diluted
derivative spectra and absorbance of all three drug were
up to 100ml with methanol to produce final stock
measured at their respective zero crossing wavelength
solution of 100 µg/ml of PCM. Standard stock solution
of ACF and RAB was prepared similarly as that of
PCM. Then the resulting solutions were scanned over
RESULTS AND DISCUSSION
the range of 390-190 nm to give their absorbance
The reproducibility, repeatability and accuracy of the
spectra then their spectra were converted to their first
proposed method were found to be satisfactory (Table
3) which is evidenced by low values of standard
Zero crossing wavelength technique was used to select
deviation, percent relative standard deviation and
the working wavelength for each of three drugs from
standard error. The percent range of error (within 95%
the overlay derivative spectra of the PCM, ACF and
confidence limits) showed precision of the method. The
RAB (fig 1). From the technique the working
accuracy and reproducibility of the proposed method
wavelength was found 271, 257, and 297 for PCM,
was confirmed by recovery experiments, performed by
adding known amount of the drugs to the pre analyzed
formulations and reanalyzing the mixture by proposed
Sample preparation:
method. The percent recovery obtained indicates non-
Twenty tablets of Ace-Proxyvon (label claim as
interference from the excipients used in the
containing 500 mg of PCM, 100 mg of ACF and 10 mg
formulations. Thus the method developed in the present
of RAB) were weighed, crushed and powder equivalent
investigation found to be simple, sensitive, accurate and
to 50 mg of PCM, 10 mg of ACF and 1 mg RAB (tablet
precise and can be successfully applied for the
contains 500 mg PCM, 100 mg ACF and 10 mg RAB)
simultaneous estimation of PCM, ACF and RAB in
was extracted four time with 20 ml methanol each time
and volume was made up to 100 ml. residue was filtered using Whatman grade filter paper. The filtrate was further diluted and concentration of Rabeprazole TABLE 1: QUANTIFICATION PARAMETERS OF PCM, ACF AND RAB.
Mean %+ S.D.
99.00+1.19
99.52+0.454
100.38+1.19 115 Available online on www.ajpls.com Original Research Article
Asian Journal of Pharmacy & Life Science, Vol. 1 (2), March-June, 2011 ISSN 2231 – 4423
TABLE 2: QUANTIFICATION PARAMETERS OF PCM, ACF AND RAB.
Mean %+ S.D.
99.11+0.407
99.54+0.501
99.37+0.371
TABLE 3: VALIDATION OF DEVELOPED METHODS
99.52+0.370
99.49+0.485
99.52+0.370
99.72+0.445 116 Available online on www.ajpls.com Original Research Article
Asian Journal of Pharmacy & Life Science, Vol. 1 (2), March-June, 2011 ISSN 2231 – 4423
Aceclofenac and Three of its Metabolites in Human Plasma by High-Performance Liquid Chromatography.
5) Saharty YS, Refaat M, Khateeb SZ. Stability
Densitometric Methods for Determination of Aceclofenac. Journal of Pharmaceutical and Biomedical Analysis 2002; 27:249-251.
Spectrofluorimetric Determination of Etodolac and Aceclofenac. Journal of Pharmaceutical and
Biomedical Analysis. 1999;20:185-188.
SPECTRA OF PCM (a), ACF (b) & RAB(c).
Moghazy AS. Determination of Aceclofenac in
Bulk and Pharmaceutical Formulations. Journal
ACKNOWLEDGEMENTS
of Pharmaceutical and Biomedical Analysis,
The authors are thankful to Ipca laboratories, Mumbai
for providing gift samples of aceclofenac and
8) Mahaparale PR, Sangshetti JN, Kuchekar BS
Ahmedabad for providing a gift sample of rabepracole.
estimation of aceclofenac and paracetamol in
The authors are grateful to College of pharmacy, IPS
tablet dosage form. Indian J Pharm Sci., 2007;
academy, Indore for providing facilities to carry out this
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117 Available online on www.ajpls.com Original Research Article
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