DEVELOPMENT AND VALIDATION OF NEW SIMPLE, SENSITIVE AND VALIDATED UV-SPECTROPHOTOMETRIC AND RP-HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF PARACETAMOL AND ETODOLAC IN MARKETED FORMULATION
Abstract
A simple, precise and highly selective analytical method was developed for simultaneous estimation of Paracetamol and Etodolac in tablet formulation. Estimation was carried out by multicomponent mode of analysis at selected wavelength of 256 and 286 nm for Paracetamol (PCM) and Etodolac (ETD) respectively in methanol: water (60:40). The method was validated in terms of linearity, accuracy (% Recovery), Precision (Interday, intraday, and reproducibility) and robustness. Both methods were linear (R2 = 0.997- 0.999 for UV method and 0.998 for RPLC method) and accurate (% recovery was 98.39-101.17%). The method was also obtained precise (% RSD <2 %) and robust. The linearity was obtained in the concentration ranges of 5.25 μg/ml for paracetamol and 3-16 μg/ml for Etodolac. The method was validated as per international conference of Harmonization (ICH) guidelines.
Keywords: Paracetamol, Etodolac, UV, RP-HPLC, ICHÂ
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References
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18. Kulkarni V.G., Gandhi S.V., Deshpande P.B., Divekar P., High Performance Thin Layer Chromatographic Analysis of Paracetamol and Etodolac in Combined Tablet Dosage Form, Journal of Chemical and Pharmaceutical Research, 2012, 4(3), 1750-1755.
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2. Indian Pharmacopoeia, 6th edition, published by The Indian Pharmacopoeia Commission, Ghaziabad, 2010, Volume-II, III, 1318,1321,1859,1861.
3. British Pharmacopoeia Published by British Pharmacopoeia Commission, London, 2010, Volume I, II, III, 847, 2677, 2967.
4. European Pharmacopoeia, 7th edition, published by the directorate for the quality of medicine and healthcare of European council, Volume II, 1981-1982,2667.
5. United State Pharmacopoeia, 34th edition NF 29, published by United State Pharmacopoeial Convention, Rockville, 2011, Volume-II, III, 2784,2786,1720,1723.
6. Klaus Florey, Analytical Profile of Drug Substances, published by Elsevier Science (USA), 3, 1-110.
7. Brittain Harry G., Analytical Profile of Drug Substances and Excipients, published by Elsevier Science (USA), Volume 29, 105-148.
8. Buddha R.S., Pradhananga R.R., Spectrophotometric Method for the Determination of Paracetamol, J. Nepal Chem. Soc., 2009, 24.
9. Roy J., Saha P., Sultana S., Kenyon A. S., Rapid screening of marketed paracetamol tablets: use of thinlayer chromatography and a semi quantitative spot test, Bulletin of the World Health Organization, 1997, 75 (1), 19-22.
10. Kirtawade R., Salve P., Seervi C., Kulkarni A., Dhabale P., Simultaneous UV Spectrophotometric Method for Estimation of Paracetamol and Nimesulide in Tablet Dosage Form, International Journal of ChemTech Research, 2010, 2(2), 818-821.
11. Sharma K.K., Patel P.U., First Derivative Spectrophotometric Method for the Simultaneous Estimation of Tolperisone and Paracetamol in their Combined Dosage Form, Journal of Pharmaceutical Science and Bioscientific Research, 2012, 2(2), 92-96.
12. Patel H.M, Suhagia B.N., Shah S.A, Marolia B.P., Bodiwala K.B., Prajapati P.B., Simultaneous Estimation of Etoricoxib and Paracetamol in the Synthetic Mixtures and Pharmaceutical Dosage Forms by Derivative Spectrophotometry, Journal of Pharmacy Research, 2010, 3(8),1967-1970
13. Shah D.A. , Patel N.J., Baldania S.L., Chhalotiya U.K., Bhatt K.K., Stability Indicating LC-Method for Estimation of Paracetamol and Lornoxicam in Combined Dosage Form, Sci Pharm. 2011, 79, 113–122.
14. Bhandari A., Solanki R., Nagori B. P, Nawal M., Bhandari M., UV Spectrophotometric determination of Etodolac in tablet dosage form, Journal of Pharmacy Research, 2011, 4(10), 3309-3311.
15. Ola A.S., Aida A.E., Hassan Y.A., Amr M., Rashed M.S., Development and Validation of Stability- Indicating High Performance Liquid Chromatographic (HPLC) and DD1-Spectrophotometric Assays for Etodolac in Bulk Form and in Pharmaceutical Dosage Form, Journal of Liquid Chromatography & Related Technologies, 2009, 32, 2584-2599.
16. Thankappan S., Parmar A., Sailor B., Vekariya K., Khasia V., Development and Validation of Spectroscopic method for Simultaneous Estimation of Etodolac and Thiocolchicoside in tablet formulation, Journal of Pharmacy Research, 2012, 5(6), 3004-3007.
17. Dhiware A.D., Gandhi S.V., Deshpande P.B., Bhavnani V.S., A simple and sensitive RP-HPLC method for simultaneous estimation of etodolac and thiocolchicoside in combined tablet dosage form, International journal of pharmacy and pharmaceutical sciences, 2012, 4 (4), 214-216.
18. Kulkarni V.G., Gandhi S.V., Deshpande P.B., Divekar P., High Performance Thin Layer Chromatographic Analysis of Paracetamol and Etodolac in Combined Tablet Dosage Form, Journal of Chemical and Pharmaceutical Research, 2012, 4(3), 1750-1755.
19. ICH, Q2 (R1), Validation of analytical procedures: text and methodology; 27 October 1994.
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Shaikh A, Singh G, Jain N, Gupta M. DEVELOPMENT AND VALIDATION OF NEW SIMPLE, SENSITIVE AND VALIDATED UV-SPECTROPHOTOMETRIC AND RP-HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF PARACETAMOL AND ETODOLAC IN MARKETED FORMULATION. JDDT [Internet]. 15Jul.2017 [cited 19May2022];7(4):120-4. Available from: http://jddtonline.info/index.php/jddt/article/view/1476
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