Author(s): Tushar Bhatkar, Pramod Burakle, Prashant Ajmire, Rahul Jawarkar, Pravin Khatale, Ekant Taywade

Email(s): tusharbhatkar10@gmail.com

DOI: 10.52711/0974-360X.2024.00450   

Address: Tushar Bhatkar1*, Pramod Burakle1, Prashant Ajmire2, Rahul Jawarkar1, Pravin Khatale1, Ekant Taywade1
1Department of Pharmaceutical Chemistry, Dr. Rajendra Gode Institute of Pharmacy, Amravati – 444901.
2Department of Pharmacology, Dr. Rajendra Gode Institute of Pharmacy, Amravati – 444901.
*Corresponding Author

Published In:   Volume - 17,      Issue - 6,     Year - 2024


ABSTRACT:
For the detection of Rivaroxaban in Pharmaceutical Tablet dosage form, a straightforward, rapid, highly selective, accurate, and exact reverse phase high performance liquid chromatographic (RP-HPLC) approach was designed and validated. The Adamas C8, (150 4.6mm, 5µm) column was used for the development, and the oven temperature used was 30°C. A 60:40% (v/v) combination of acetonitrile and water made up the solvent reservoir mobile phase. With a DAD detector, the flow rate was 1.0 ml per minute, and the wavelength was 253nm. The run time was limited to five minutes. Using EZ Chrome software, the separation was performed using an Agilent 1100 series HPLC. Rivaroxaban's retention period was measured at 3.680 minutes. According to ICH Q2 R1 recommendations, the method was validated in terms of parameters including linearity, accuracy, precision, specificity, limit of detection, limit of quantification, and robustness. With a correlation coefficient of 0.9998, the linearity was in the 10–50µg/ml range. Less than 2% was discovered to be the accuracy's relative standard deviation. The average recovery rate ranged from 100.12% to 101.58%. Limits of quantification and detection were discovered to be 0.3µg/ml and 1.0µg/ml, respectively. The suggested method for determining the dosage of Rivaroxaban in tablet form was successfully established.


Cite this article:
Tushar Bhatkar, Pramod Burakle, Prashant Ajmire, Rahul Jawarkar, Pravin Khatale, Ekant Taywade. RP-HPLC Method Development and Validation of Rivaroxaban in Pharmaceutical Tablet Dosage Form. Research Journal of Pharmacy and Technology. 2024; 17(6):2869-4. doi: 10.52711/0974-360X.2024.00450

Cite(Electronic):
Tushar Bhatkar, Pramod Burakle, Prashant Ajmire, Rahul Jawarkar, Pravin Khatale, Ekant Taywade. RP-HPLC Method Development and Validation of Rivaroxaban in Pharmaceutical Tablet Dosage Form. Research Journal of Pharmacy and Technology. 2024; 17(6):2869-4. doi: 10.52711/0974-360X.2024.00450   Available on: https://rjptonline.org/AbstractView.aspx?PID=2024-17-6-69


REFERENCES:
1.    Duggan ST. Rivaroxaban: a review of its use for the prophylaxis of venous thromboembolism after total hip or knee replacement surgery. American Journal of Cardiovascular Drugs. 2012 Feb; 12: 57-72. doi: 10.2165/11208470-000000000-00000.
2.    Raju NA, Begum S. Simultaneous RP-HPLC method for the estimation of the emtricitabine, tenofovir disoproxil fumerate and efavirenz in tablet dosage forms. Research Journal of Pharmacy and Technology. 2008; 1(4): 522-5. DOI: 10.5958/0974-360X
3.    Pulla RP, Sastry BS, Prasad YR, Raju NA. Simultaneous Estimation of Metformin HCl and Sitagliptin Phosphate in Tablet Dosage Forms by RP-HPLC. Research Journal of Pharmacy and Technology. 2011; 4(4): 646-9. DOI: 10.5958/0974-360X
4.    Nagappan KV, Meyyanathan SN, Raja RB, Reddy S, Jeyaprakash MR, Birajdar AS, Bhojraj S. A RP-HPLC method for Simultaneous Estimation of Ambroxol Hydrochloride and Loratidine in pharmaceutical formulation. Research Journal of Pharmacy and Technology. 2008; 1(4): 366-9. DOI: 10.5958/0974-360X
5.    Valarmathy J, Samueljoshua L, Rathinavel G, Thanuja CS, Sivakumar T. RP-HPLC Method development and validation for assay of Levetiracetam in tablet dosage Form. Research Journal of Pharmacy and Technology. 2008; 1(4): 395-7.  10.5958/0974-360X
6.    Deokar AU, Siddheshwar S, Kakad SB. Analytical method development and validation of rivaroxaban-A review. Research Journal of Science and Technology. 2020; 12(1): 36-46. DOI: 10.5958/2349-2988.2020.00004.2
7.    Seshamamba BS, Satyanarayana PV, Sekaran CB. Application of stability indicating HPLC method with UV detector to the analysis of rivaroxaban in bulk and tablet dosage form. Chem. Sci. Trans. 2014; 3: 1546-54. DOI:10.7598/cst2014.893
8.    Kumar VK, Raju NA, Begum S, Rao JS, Satyanarayana T. The estimation of gefitinib in tablet dosage forms by RP-HPLC. Research Journal of Pharmacy and Technology. 2009; 2(2): 341-3. DOI: 10.5958/0974-360X
9.    Kasad PA, Muralikrishna KS. Base degradation study and method development of rivaroxaban by RP-HPLC in bulk. Asian Journal of Pharmacy and Technology. 2013; 3(3): 98-101. DOI: 10.5958/2231–5691
10.    Sudha T, Shanmugasundram P. Development and validation of RP-HPLC and HPTLC chromatographic methods of analysis for the quantitative estimation of raltegravir potassium in pharmaceutical dosage form. Research Journal of Pharmacy and Technology. 2011; 4(11): 1746-50. DOI: 10.5958/0974-360X
11.    Badroon T, Sreeramulu J. Development and validation of stability indicating assay by HPLC method for estimation of Rivaroxaban. International Journal of Bio-Pharma Research. 2019; 8(5): 2582-6. http://dx.doi.org/10.21746/ijbpr.2019.8.5.5
12.    Dinda SC, Desireddy RB, Kumar PJ, Chand AS, Rao PS, Kumar BA. Development and validation of RP-HPLC method for qunatitative analysis of Amlodipine besylate in pure and Pharmaceutical formulations. Research Journal of Pharmacy and Technology. 2013; 6(2): 204-7. DOI: 10.5958/0974-360X
13.    Rao CM, Konda R, Rao RN, Ramanjeneeyulu S, Reddy PG. Estimation of Nevirapine Anhydrous Bulk Formulation by Using IR, RP-HPLC, GC Methods. Research Journal of Pharmacy and Technology. 2010; 3(4): 1088-92. DOI: 10.5958/0974-360X
14.    Pawar HI, Kothapalli L, Thomas A, Nanda RK, Mare S. Simultaneous RP-HPLC method for estimation of ezetimibe and fenofibrate in synthetic mixture. Research Journal of Pharmacy and Technology. 2008; 1(1): 25-8. DOI: 10.5958/0974-360X
15.    Vaghela D, Patel P. High performance thin layer chromatographic method with densitometry analysis for determination of rivaroxaban from its tablet dosage form. International Journal of Pharmacy and Pharmaceutical Sciences. 2014; 6(6): 383-6.
16.    Lavanya G, Sunil M, Eswarudu MM, Eswaraiah MC, Harisudha K, Spandana BN. Analytical method validation: an updated review. International Journal of Pharmaceutical Sciences and Research. 2013 Apr 1; 4(4): 1280. DOI: https://doi.org/10.22159/ijap.2018v10i6.28279
17.    Guideline IH. Validation of analytical procedures: text and methodology. Q2 (R1). 2005 Nov; 1(20): 05.
18.    Guideline IH. Stability testing of new drug substances and products. Q1A (R2), current step. 2003 Feb; 4(1-24).
19.    Sankar PR, Swathi V, Babu PS. Development and validation of novel UV and RP-HPLC methods for determination of cilnidipine (a new generation ca channel blocker) in pharmaceutical dosage form. International Journal of Pharmaceutical Sciences and Research. 2019; 10: 1886-94. DOI: 10.13040/IJPSR.0975-8232.10(4).1886-94
20.    Singh M, Kashkhedikar SG, Soni L, Garg A, Gandhi T, Patel A. Development of RP-HPLC method for estimation of carvedilol in tablet formulations. Research Journal of Pharmacy and Technology. 2008; 1(1): 18-21. DOI: 10.5958/0974-360X.


Recomonded Articles:

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 

1.3
2021CiteScore
 
56th percentile
Powered by  Scopus


SCImago Journal & Country Rank


Recent Articles




Tags


Not Available