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Asian Journal of Pharmacy & Life Science, Vol. 1 (2), March-June, 2011 ISSN 2231 – 4423
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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. -----------------------------------------------------------------------------------------------------------------------------------------
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.
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Corresponding Author’s E-mail: - [email protected]
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
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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 REFERENCES -
1) The British Pharmacopoeia Commission. British Pharmacopoeia, Vol. II, London: the Stationery paracetamol and aceclofenac in tablets. Indian J 2) Indian Pharmacopoeia, 4th edition. New Delhi: 10) ICH, Q2A Text on Validation of Analytical The Controller of Publications, Government of 3) The British Pharmacopoeia Commission. British 11) ICH, Q3B Validation of Analytical Procedures: Pharmacopoeia, Vol. I, London: the Stationery Methodology, International Conference on 4) Hinz B, Auge D, Rau T, Rietbrock S, Brune K, 117 Available online on www.ajpls.com Original Research Article

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