Author(s): Nazira Sarkis, Yaser Bitar, Mohamad Medhat Sarraj

Email(s): nazirasarkis@gmail.com , medhatsarraj@gmail.com

DOI: 10.5958/0974-360X.2020.00953.1   

Address: Nazira Sarkis1*, Yaser Bitar2, Mohamad Medhat Sarraj3
1Department of Analytical and Food Chemistry, Faculty of Pharmacy, University of Aleppo, Syria.
2Department of Pharmaceutical Chemistry and Quality Control, Faculty of Pharmacy, University of Aleppo, Syria.
*Corresponding Author

Published In:   Volume - 13,      Issue - 11,     Year - 2020


ABSTRACT:
A Simple, sensitive, rapid, precise and accurate RP-HPLC method has been developed and validated for simultaneous estimation Aspirin and Rivaroxaban in synthetic mixture. The separation process was developed under optimized chromatographic conditions using a reversed phase of C18 column and a mobile phase consists of acetonitrile and water (65:35v/v) adjusted to pH 5.6 with The acetate buffer, flow rate used was (1.1ml/min), the temperature was 27°C and UV detection at 245nm. The retention time of Aspirin and Rivaroxaban was found to be 2.1min and 3.2min respectively. Developed method was validated according to ICH Q2 (R1) guidelines. The method was found to be linearity (R2>0.999) in the concentration range of (10 – 600) µg/ml for Aspirin and (10-100) µg/ml for Rivaroxaban. The precision (intra-day, inter-day) data of this method was found to be within limits (% RSD < 2%), The mean recoveries obtained for aspirin and Rivaroxaban were (99.60 - 101.10)% respectively, so developed method was found to be accurate.


Cite this article:
Nazira Sarkis, Yaser Bitar, Mohamad Medhat Sarraj. Development and Validation of RP-HPLC Method for Simultaneous Estimation of Aspirin and Rivaroxaban in Synthetic Mixture. Research J. Pharm. and Tech. 2020; 13(11):5459-5465. doi: 10.5958/0974-360X.2020.00953.1


REFERENCES:
1.    Patel GF, Vekariya NR, Dholakiya, RB. Estimation of Aspirin and Atorvastatin Calcium in Combine Dosage Form Using Derivative Spectrophotometric Method. Int. J. Pharm. Res. 2010; 2(1): 62-66.
2.    Purushotam KS, Mrinalini CD, Bothara KG. A Validated Stability Indicating HPTLC Method for Determination of Aspirin and Clopidogrel Bisulphate in Combined Dosage Form. Eur. J Anal. Chem. 2009; 4(2): 152-160.
3.    Paez-Espinosa E, Murad J, Khasawneh F. Aspirin: Pharmacology and Clinical Applications. Hindawi Publishing Corporation Thrombosis, 2012; (15).
4.    European Medicines Agency (EMEA). CHMP Assessment Report for Xarelto. Available at: http://www.emea.europa.eu/humandocs/PDFs/EPAR/ xarelto/H-944-en6.pdf. 2008. Accessed January 14, 2010.
5.    Perzborn E, Strassburger J, Wilmen A. In vitro and in vivo studies of the novel antithrombotic agent BAY 59–7939 an oral, direct factor Xa inhibitor. J Thromb Haemost. 2005; 3: 514–521.
6.    Kubitza D, Becka M, Voith B, Zuehlsdorf M, Wensing G. Safety, pharmacodynamics, and pharmacokinetics of single doses of BAY 59 7939, an oral, direct factor Xa inhibitor. Clin Pharmacol Ther. 2005; 78: 412–421.
7.    U.S. FDA Approves XARELTO® (rivaroxaban) to Reduce the Risk of Major Cardiovascular Events in Patients with Chronic Coronary Artery Disease (CAD) or Peripheral Artery Disease (PAD) [news release]. Titusville, NJ; October 11, 2018: Janssen Pharmaceuticals website. https://www.janssen.com/us-fda-approves-xareltor-rivaroxaban-reduce-risk-major-cardiovascular-events-patients-chronic. Accessed October 12, 2018.
8.    Kokot Z, Burda K. Simultaneous determination of salicylic acid and acetylsalicylic acid in aspirin delayed release tablets formulation by second-derivative UV Spectrophotometry. J. Pharma. Bio. 1998; 18: 871-875.
9.    Murtaza G, Khan SA, Shabbir A, Mahmood A, Asad MHHB, Farzana K, Malik NS, Hussain I. Development of a UV spectrophotometric method for the simultaneous determination of aspirin and paracetamol in tablets. Sci. Res. Ess. 2011; 6: 417-421.
10.    Panchal HJ, Suhagia BN, Patel NJ. Simultaneous HPTLC analysis of atorvastatin calcium, ramipril and aspirin in capsule dosage form. J. Planar Chromatogr. 2009; 22: 265-271.
11.    Sinha PK, Damle MC, Bothra KG. A validated stability indicating HPTLC method for the determination of aspirin and clopidrogrel bisulphate in combined dosage form. Eur. J. Anal. Chem. 2009; 4: 152-160.
12.    Jain D K, Jain N, Verma J. RP-HPLC Method for Simultaneous Estimation of Aspirin and Prasugrel in Binary Combination International. Journal of Pharmaceutical Sciences and Drug Research. 2012; 4(3): 218-221.
13.    Panchal A, Sanghvi G, Vachhani A, Sheth N, Vaishnav D. Simultaneous determination of Aspirin and Rosuvastatin Calcium in capsules by using RPHPLC coupled with photo diode array detection. International Letters of Chemistry, Physics and Astronomy. 2014; 33: 218-230.
14.    Chodvadiya FJ, Thula KC, Maheshwari DG. Simultaneous estimation of aspirin and lansoprazole by RP–HPLC method. International Journal of Recent Scientific Research. 2015; 6(4): 3385-3390
15.    Gandimati M, Ravi TK, Abraham A, Thomas R. Simultaneous determination of aspirin and isosorbide 5-mononitrate in formulation by RP-HPLC. J. Pharm. Biomed. 2003; 32: 1145-1148.
16.    Pirola R, Bareggi SR, Benedittis GD. Determination of acetylsalicylic acid and salicylic acid in skin and plasma by high performance liquid chromatography. J. Chromatogr B. 1998; 705: 309-315.
17.    Tsikasa D, Tewesa KS, Gutzkia FM, Schwedhelma E, Greipel J, Frolich JC. Gas chromatographic-tandem mass spectrometric determination of acetylsalicylic acid in human plasma after oral administration of low-dose aspirin and guaimesal. J. Chromatogr B. 1998; 709: 79-88.
18.    Umapathi P, Parimoo P, Thomas SK, Agarwal V. Spectrofluorometric estimation of aspirin and dipyridamole in pure admixtures and in dosage forms. J. Pharm. Biomed. 1997; 15: 1703-1708.
19.    Ahmed M, Biswas HU, Sadik G. Development of a spectrometric method for the determination of aspirin in blood samples. J. Med. Sci. 2001; 2:61-62.
20.    Sekaran CB, Bind VH, Damayanthi MR, Sireesha A. Development and validation of UV spectrophotometric method for the determination of rivaroxaban. Der Pharma Chemica. 2013; 5(4): 1-5.
21.    Celebier M, Kaynak MS, Altınoz S, Sahin S. UV Spectrophotometric Method for Determination of the Dissolution Profile of Rivaroxaban. Dissolution Technologies. 2014; 56-59.
22.    Mehta AR, Maheshwari DG. Development and validation of first uv spectrophotometric method and RP-HPLC method for simultaneous estimation of rivaroxaban and ticagrelor in synthetic mixture. Journal of Global Trends in Pharmaceutical Sciences. 2018; 9(2): 5275 – 5297.
23.    Celebier M, Recber T, Kocak E, Altınoz S. RP-HPLC method development and validation for estimation of rivaroxaban in pharmaceutical dosage forms. Brazilian Journal of Pharmaceutical Sciences. 2013; 49(2): 360-366.
24.    Sunny A, Sreedhar C, Akkama HG, Mahapatra A. (2017). Development of New Analytical Method and Vallidation For Quantitative Estimation of Rivaroxaban in Formulation and Bulk Drug. International Journal of Scientific Research in Education. 2017; 5(5): 6469-6478.
25.    Sahoo S, Mekap SK. Assay comparison of rivaroxaban by new HPLC method with an existing method in tablet dosage form. Pharmaceutical and Biological Evaluations. 2017; 4(3): 180-182.
26.    Avachat AM, Yamgar MP. RP-HPLC method development and validation for the estimation of rivaroxaban in bulk and tablet dosage form. World Journal of Pharmacy and Pharmaceutical sciences. 2017; 6(8): 1775-1784.
27.    Seshamamba B, Satyanarayana P, Sekaran C. Application of Stability Indicating HPLC Method with UV Detector to the Analysis of Rivaroxaban in Bulk and Tablet Dosage Form. Chemical Science Transactions. 2014; 3(4): 1546-1554.
28.    Arous B, Al-Mardini MA, Ghazal H, Al-Lahham F. Stability-Indicating, Method, for the Determination, of Rivaroxaban, and its Degradation, Products, using, LC-MS, and, TLC. Research J. Pharm. and Tech. 2018; 11(1): 8.
29.    ICH Q2(R1). Validation of Analytical Procedures: Text and Methodology. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. 2005
30.    Stoll VS, Blanchard JS. Buffers: Principles and Practice. Academic Press, 1990; 463(6).

Recomonded Articles:

Author(s): A. S. K. Sankar, B. Datchayani, N. Balakumaran, Mohammed Rilwan, R. Subaranjani

DOI: 10.5958/0974-360X.2017.00047.6         Access: Open Access Read More

Author(s): Rekha Rajendran, R Hemachander, T Ezhilarasan, C Keerthana, DL Saroja, KV Saichand, Mohamed Gasim Abdullah

DOI: Not Available         Access: Open Access Read More

Author(s): Narendra Chotai, Vishnu Patel, Harsha Patel, Uren Patel, Rajendra Kotadiya

DOI:         Access: Open Access Read More

Author(s): Mukta D. Naykode, Durgacharan A. Bhagwat, Swapnil D. Jadhav, Harinath N. More

DOI: 10.5958/0974-360X.2017.00133.0         Access: Open Access Read More

Author(s): Mayanka Singh, Manoj Charde, Rajesh Shukla, Rita M. Charde

DOI: Not Available         Access: Open Access Read More

Author(s): Shrivastava Alankar, Jain R., Agrawal R.K., Ahirwar D.

DOI:         Access: Open Access Read More

Author(s): S. Poongothai, C.M. Karrunakaran, R. Ilavarasan

DOI: Not Available         Access: Open Access Read More

Research Journal of Pharmacy and Technology (RJPT) is an international, peer-reviewed, multidisciplinary journal.... Read more >>>

RNI: CHHENG00387/33/1/2008-TC                     
DOI: 10.5958/0974-360X 

0.38
2018CiteScore
 
56th percentile
Powered by  Scopus


SCImago Journal & Country Rank


Recent Articles




Tags