Development and Validation of Area Under Curve Spechtrophotometry Method For Binary Mixture Of Paracetamol and Ibuprofen In Tablet Dosage Form
Abstract
The combination of paracetamol (PAR) and ibuprofen (IBU) is the most commonly used over-the-counter medication for fever and pain. This study aimed to develop spechtrophotometry method by area under curve to determine the levels of PAR and IBU in tablet dosage form.
This method is based on the area under the curve value of each spectrum in various concentrations is calculated to selected wavelength range analysis, with methanol as solvent. Then, this method was applied to determine levels of PAR and IBU in tablet dosage form.
The result of this method is the analysis of selected wavelength ranges of PAR and IBU in the wavelength ranges of 244-254 nm and 220-230 nm, respectively. The mean % recoveries were found to be in 99.35% and 99.49% for PAR and IBU, respectively. The method is successfully applied to determine PAR and IBU in tablet dosage form simultaneously and fulfill the validation requirements.
Keywords:
paracetamol; ibuprofen; spechtrophotometry; area under curve
References
REFERENCES
[1]. Aitken P., Stanescu I., Playne R., Zhang J., Frampton C.M., Atkinson H.C.. 2019. An Integrated Safety Analysis Of Combined Acetaminophen And Ibuprofen (Maxigesic®/Combogesic®) In Adults. Journal of Pain Research. 12: 621–634.
[2]. Tan E., Braithwaite I., McKinlay C.J.D., Dalziel S.R. 2020. Comparison of Acetaminophen (Paracetamol) With Ibuprofen For Tretament of Fever Pain in Children Younger Than 2 Years: A Systematic Review and Meta-Analysis. JAMA Netw Open. 3(10):e2022398. doi: 10.1001/jamanetworkopen.2020.22398.
[3].Deshpande A., Bhargava D., Gupta M. 2014. Analgesic Efficacy Of Acetaminophen For Controlling Postextraction Dental Pain. Annals of Maxillofacial Surgery. 4(2): 176-177. DOI: 10.4103/2231-0746.147117.
[4]. Martino M.D., Chiarugi A. 2015. Recent Advances in Pediatric Use of Oral Paracetamol in Fever and Pain Management: Review. Pain Ther. 4:149–168. DOI 10.1007/s40122-015-0040-z.
[5]. Issa Y.M., Zayed S.I.M., Habib I.H.I. 2011. Simultaneous Determination Of Ibuprofen And Paracetamol Using Derivatives Of The Ratio Spectra Method. Arabian Journal of Chemistry. 4: 259-263. doi:10.1016/j.arabjc.2010.06.044.
[6]. Ferreira T.R, Lopes L.C. 2016. Analysis of Analgesic, Antipyretic, and Nonsteroidal Anti-Inflammatory Drug Use In Pediatric Prescriptions. J Pediatr (Rio J). 92: 81-87. http://dx.doi.org/10.1016/j.jped.2015.04.007.
[7]. Alsaad A.A.A., Alassadi E.A.S., Al‑Salman H. N. K., Hussein H.H. 2019. The Simultaneous Determination of Ibuprofen and Paracetamol in Pharmaceutical Formulations by High‑performance Liquid Chromatography with Ultraviolet Detection. Asian Journal of Pharmaceutics. 13(2): 141-152.
[8]. Elkady Y., El-Adl S.M., Baraka M., Sebaiy M.M. 2020. HPLC Method for Simultaneous Determination of Ascorbic Acid, Phenylephrine, Paracetamol, Caffeine in Their Pure and Dosage Forms. International Journal of Advanced Research in Chemical Science. 7(6): 7-16. DOI: https:// doi.org/10.20431/2349-0403.0706002.
[9]. Kanthale S.B., Thonte S.S., Pekamwar S.S., Mahapatra D.K. 2020. Development of a Rapid Chemometric Reverse Phase HPLC Method for the Simultaneous Estimation of Paracetamol and Ibuprofen in Bulk and Tablet Formulation. Int J Cur Res Rev. 12(23): 98-108. DOI: http://dx.doi.org/10.31782/IJCRR.2020.122331.
[10]. Alkhafaji S.L. and Mahood A.M. 2018. First-order Derivative and UV-Spectrophotometric Methods for Simultaneous Determination of Paracetamol, Ibuprofen, and Caffeine in Bulk and Parmaceutical Formulatation. Journal of Pharmaceutical Research International. 25(2): 1-14. DOI:10.9734/JPRI/2018/46503.
[11]. Mallah M.A., Sherazi S.T.H., Mahesar S.A., Khaskheli A.R. 2012. Simultaneous Quantification of Ibuprofen and Paracetamol in Tablet Formulations Using Transmission Fourier Transform Infrared Spectroscopy. American Journal of Analytical Chemistry. 3: 503-511. http://dx.doi.org/10.4236/ajac.2012.38067.
[12]. Lima A.B., Torres L.M.F.C., Guimarães C.F.R.C., Verly, R.M., Silva L.M.D., Júnior Á.D.C, Santos W.T.P.D. 2014. Simultaneous Determination of Paracetamol and Ibuprofen in Pharmaceutical Samples by Differential Pulse Voltammetry Using a Boron-Doped Diamond Electrode. J. Braz. Chem. Soc. 25(3): 478-483. http://dx.doi.org/10.5935/0103-5053.20140005.
[13].Ayalew M.E., Ayitegeb D.Y. 2021. Differential Pulse Voltammetric Determination of Paracetamol Using Activated Glassy Carbon Electrode. American Journal of Physical Chemistry. 10(2): 16-24. doi: 10.11648/j.ajpc.20211002.11.
[14]. Makwana S., Patel M., Singh B., Upadhyay J., Shah A. 2015. Development And Validation Of A Stability Indicating RP-UPLC Method For The Determination Of Paracetamol And Ibuprofen In Tablet. J. Chem. Pharm. Res. 7(4):1308-1315.
[15]. Tarigan R.E., Muchlisyam, Sinaga S.M., Alfian Z. 2021. Development and Validation of Area under Curve Spectrophotometry Method for Ternary Mixture of Dextromethorphan HBr, Doxylamine Succinate and Pseudoephedrine HCl in Tablet Dosage Form. AIP Conf. Proc. 2342. 020001-1–020001-4. https://doi.org/10.1063/5.0045551.
[16]. Tarigan R.E., Muchlisyam, Sinaga S.M., Alfian Z. 2021. Simultaneous Determination Of Dextromethorphan Hydrobromide, Doxylamine Succinate And Pseudoephedrine Hydrochloride In Cough And Cold Syrup By Area Under Curve Spectrophotometry Method. Rasayan J. Chem. 14(1): 629-634. http://dx.doi.org/10.31788/ RJC.2021.1416068.
[17]. Nasution L.R., Bachri M., Putra D.E.L. 2018. Simultaneous Estimation Of Isoniazid And Pyridoxine Hydrochloride In Tablet Dosage Form By Spectrophotometry Ultraviolet With Area Under Curve Method. Asian J Pharm Clin Res. 11(5): 124-126. http://dx.doi.org/10.22159/ajpcr.2018.v11i5.24314.
[18]. Bachri M., Tuty R.P., Edward R. 2018. Quantitative Analysis Of Acetaminophen And Ibuprofen Mixture In Tablet Utilizing Centered Average On Spectrum Ratio By Spectrophotometric Technique. Asian J Pharm Clin Res. 11(12): 344-349. http://dx.doi.org/10.22159/ajpcr.2018.v11i12.28093.
[19]. Tarigan R.E., Muchlisyam, Sinaga S.M., Alfian Z. 2020. Development And Validation Of Double Divisor Ratio Spectra Derivative Spectrophotometry Method For Ternary Mixture Of Dextromethorphan Hydrobromide, Doxylamine Succinate And Pseudoephedrine Hydrochloride In Tablet Dosage Form. Int J App Pharm. 12(6): 249-252. http://dx.doi.org/10.22159/ijap.2020v12i6.39037.
[20]. Khandare B., Dudhe P.B., Upasani S., Dhoke M. 2019. Spectrophotometric Determination of Vandetanib in Bulk by Area Under Curve and First Order Derivative Methods. International Journal of PharmTech Research. 12(2): 103-110. http://dx.doi.org/10.20902/IJPTR.2019.120202.
[1]. Aitken P., Stanescu I., Playne R., Zhang J., Frampton C.M., Atkinson H.C.. 2019. An Integrated Safety Analysis Of Combined Acetaminophen And Ibuprofen (Maxigesic®/Combogesic®) In Adults. Journal of Pain Research. 12: 621–634.
[2]. Tan E., Braithwaite I., McKinlay C.J.D., Dalziel S.R. 2020. Comparison of Acetaminophen (Paracetamol) With Ibuprofen For Tretament of Fever Pain in Children Younger Than 2 Years: A Systematic Review and Meta-Analysis. JAMA Netw Open. 3(10):e2022398. doi: 10.1001/jamanetworkopen.2020.22398.
[3].Deshpande A., Bhargava D., Gupta M. 2014. Analgesic Efficacy Of Acetaminophen For Controlling Postextraction Dental Pain. Annals of Maxillofacial Surgery. 4(2): 176-177. DOI: 10.4103/2231-0746.147117.
[4]. Martino M.D., Chiarugi A. 2015. Recent Advances in Pediatric Use of Oral Paracetamol in Fever and Pain Management: Review. Pain Ther. 4:149–168. DOI 10.1007/s40122-015-0040-z.
[5]. Issa Y.M., Zayed S.I.M., Habib I.H.I. 2011. Simultaneous Determination Of Ibuprofen And Paracetamol Using Derivatives Of The Ratio Spectra Method. Arabian Journal of Chemistry. 4: 259-263. doi:10.1016/j.arabjc.2010.06.044.
[6]. Ferreira T.R, Lopes L.C. 2016. Analysis of Analgesic, Antipyretic, and Nonsteroidal Anti-Inflammatory Drug Use In Pediatric Prescriptions. J Pediatr (Rio J). 92: 81-87. http://dx.doi.org/10.1016/j.jped.2015.04.007.
[7]. Alsaad A.A.A., Alassadi E.A.S., Al‑Salman H. N. K., Hussein H.H. 2019. The Simultaneous Determination of Ibuprofen and Paracetamol in Pharmaceutical Formulations by High‑performance Liquid Chromatography with Ultraviolet Detection. Asian Journal of Pharmaceutics. 13(2): 141-152.
[8]. Elkady Y., El-Adl S.M., Baraka M., Sebaiy M.M. 2020. HPLC Method for Simultaneous Determination of Ascorbic Acid, Phenylephrine, Paracetamol, Caffeine in Their Pure and Dosage Forms. International Journal of Advanced Research in Chemical Science. 7(6): 7-16. DOI: https:// doi.org/10.20431/2349-0403.0706002.
[9]. Kanthale S.B., Thonte S.S., Pekamwar S.S., Mahapatra D.K. 2020. Development of a Rapid Chemometric Reverse Phase HPLC Method for the Simultaneous Estimation of Paracetamol and Ibuprofen in Bulk and Tablet Formulation. Int J Cur Res Rev. 12(23): 98-108. DOI: http://dx.doi.org/10.31782/IJCRR.2020.122331.
[10]. Alkhafaji S.L. and Mahood A.M. 2018. First-order Derivative and UV-Spectrophotometric Methods for Simultaneous Determination of Paracetamol, Ibuprofen, and Caffeine in Bulk and Parmaceutical Formulatation. Journal of Pharmaceutical Research International. 25(2): 1-14. DOI:10.9734/JPRI/2018/46503.
[11]. Mallah M.A., Sherazi S.T.H., Mahesar S.A., Khaskheli A.R. 2012. Simultaneous Quantification of Ibuprofen and Paracetamol in Tablet Formulations Using Transmission Fourier Transform Infrared Spectroscopy. American Journal of Analytical Chemistry. 3: 503-511. http://dx.doi.org/10.4236/ajac.2012.38067.
[12]. Lima A.B., Torres L.M.F.C., Guimarães C.F.R.C., Verly, R.M., Silva L.M.D., Júnior Á.D.C, Santos W.T.P.D. 2014. Simultaneous Determination of Paracetamol and Ibuprofen in Pharmaceutical Samples by Differential Pulse Voltammetry Using a Boron-Doped Diamond Electrode. J. Braz. Chem. Soc. 25(3): 478-483. http://dx.doi.org/10.5935/0103-5053.20140005.
[13].Ayalew M.E., Ayitegeb D.Y. 2021. Differential Pulse Voltammetric Determination of Paracetamol Using Activated Glassy Carbon Electrode. American Journal of Physical Chemistry. 10(2): 16-24. doi: 10.11648/j.ajpc.20211002.11.
[14]. Makwana S., Patel M., Singh B., Upadhyay J., Shah A. 2015. Development And Validation Of A Stability Indicating RP-UPLC Method For The Determination Of Paracetamol And Ibuprofen In Tablet. J. Chem. Pharm. Res. 7(4):1308-1315.
[15]. Tarigan R.E., Muchlisyam, Sinaga S.M., Alfian Z. 2021. Development and Validation of Area under Curve Spectrophotometry Method for Ternary Mixture of Dextromethorphan HBr, Doxylamine Succinate and Pseudoephedrine HCl in Tablet Dosage Form. AIP Conf. Proc. 2342. 020001-1–020001-4. https://doi.org/10.1063/5.0045551.
[16]. Tarigan R.E., Muchlisyam, Sinaga S.M., Alfian Z. 2021. Simultaneous Determination Of Dextromethorphan Hydrobromide, Doxylamine Succinate And Pseudoephedrine Hydrochloride In Cough And Cold Syrup By Area Under Curve Spectrophotometry Method. Rasayan J. Chem. 14(1): 629-634. http://dx.doi.org/10.31788/ RJC.2021.1416068.
[17]. Nasution L.R., Bachri M., Putra D.E.L. 2018. Simultaneous Estimation Of Isoniazid And Pyridoxine Hydrochloride In Tablet Dosage Form By Spectrophotometry Ultraviolet With Area Under Curve Method. Asian J Pharm Clin Res. 11(5): 124-126. http://dx.doi.org/10.22159/ajpcr.2018.v11i5.24314.
[18]. Bachri M., Tuty R.P., Edward R. 2018. Quantitative Analysis Of Acetaminophen And Ibuprofen Mixture In Tablet Utilizing Centered Average On Spectrum Ratio By Spectrophotometric Technique. Asian J Pharm Clin Res. 11(12): 344-349. http://dx.doi.org/10.22159/ajpcr.2018.v11i12.28093.
[19]. Tarigan R.E., Muchlisyam, Sinaga S.M., Alfian Z. 2020. Development And Validation Of Double Divisor Ratio Spectra Derivative Spectrophotometry Method For Ternary Mixture Of Dextromethorphan Hydrobromide, Doxylamine Succinate And Pseudoephedrine Hydrochloride In Tablet Dosage Form. Int J App Pharm. 12(6): 249-252. http://dx.doi.org/10.22159/ijap.2020v12i6.39037.
[20]. Khandare B., Dudhe P.B., Upasani S., Dhoke M. 2019. Spectrophotometric Determination of Vandetanib in Bulk by Area Under Curve and First Order Derivative Methods. International Journal of PharmTech Research. 12(2): 103-110. http://dx.doi.org/10.20902/IJPTR.2019.120202.
