METHOD DEVELOPMENT AND VALIDATION OF SOLID DOSAGE FORM OF RIVAROXABAN BY RP-HPLC

Main Article Content

JAVAID AHMAD KHAN
SHEIKH ABDUL KHALIQ
SADAF NAEEM
MUHAMMAD KASHIF

Abstract

The main objective of current study was to establish simple, sensitive, high-speed and precise RP-HPLC technique for the estimation of Solid Dosage form of Rivaroxaban as per ICH guidelines. Prospective experimental study conducted in the laboratories of Pharmaceutics, Faculty of Pharmacy, Hamdard University from January to September 2019. Study was carried out using LC Solution technology on Shimadzu HPLC LC-20. The separation was done by using Thermo Scientific Hypersil ODS 5 μ C18 column (4.6 x 250 mm) as a stationary phase. The mobile phase was prepared utilizing Buffer & Acetonitrile in the ratio of 700:300 (v/v) run at the flow rate of 1.0 mL/minute. The peak elution was observed at 6.177 mins at wavelength 250 nm when 10.0 mL was injected. The technique showed linear behavior in the range of 0.5% (0.101 mcg/ml) to 120% (24.139 mcg/ml) of test concentration with linear standard curve and correlation coefficient was found to be R2=0.999, peak symmetry for Rivaroxaban was excellent & the Limit of Detection and Limit of Quantification were found to be as  0.004 mcg/mL & 0.006 mcg/mL respectively. Current method was established and validated according to the ICH guidelines and all parameters were adjusted according to the US FDA designed Method Guidelines.

Keywords:
Rivaroxaban, RP-HPLC, assay, validation, acetonitrile, potassium dihydrogen phosphate

Article Details

How to Cite
KHAN, J. A., KHALIQ, S. A., NAEEM, S., & KASHIF, M. (2020). METHOD DEVELOPMENT AND VALIDATION OF SOLID DOSAGE FORM OF RIVAROXABAN BY RP-HPLC. Journal of International Research in Medical and Pharmaceutical Sciences, 15(1), 4-10. Retrieved from https://ikprress.org/index.php/JIRMEPS/article/view/5021
Section
Original Research Article

References

Pathuri R, et al. A review on analytical method development and validation of pharmaceutical technology. Current Pharma Research. 2013; 3(2):855-870.

Sharma S, Goyal S, Chauhan K. A review on analytical method development and validation. International Journal of Applied Pharmaceutics. 2018;10(6):8-15.

Chauhan A, Mittu B, Chauhan P. Analytical method development and validation: A concise review. Journal of Analytical & Bioanalytical Techniques. 2015;6(1):01-08.

Mishra MK, Kumari P. A review on pharmaceutical process validation. The Pharma Innovation Journal. 2019;8(6):950-958.

Ojha A, Bharkatiya M, Kitawat S. Pharmaceutical process validation of solid dosage forms: A review. World Journal of Pharmacy and Pharmaceutical Sciences. 2014;3(6):476-484.

Khan I, et al. Process validation: An essential process in pharmaceutical industry. World Journal of Pharmacy and Pharmaceutical Sciences. 2017;6(8):217-234.

Nandhakumar L, et al. An overview of pharmaceutical validation: Quality assurance view point. IJRPC. 2011;1(4):1003-1014.

Pande PP, et al. Quality by design in analytical method development and validation. Journal of Environment and Life Sciences. 2017;2(2):39-45.

Gourish C, Nimrata S, Vishal S. Process Validation of solid oral dosage form and process validation guidance for industry. International Research Journal of Pharmacy. 2013;4(5):36-39.

Bayer Pharma A. Xarelto® summary of product characteristics.
[Accessed September 2013]
[Cited 10]
Available:https://www.medicines.org.uk/emc/product/6402/smpc

Younos Abdulsattar, Bhambri R, Nogid A. Rivaroxaban (Xarelto) for the Prevention of thromboembolic disease an inside look at the oral direct factor xa inhibitor. P T. 2009;34(5):238–244.

Gómez-Outes A, et al. Dabigatran, rivaroxaban, or apixaban versus warfarin in patients with nonvalvular atrial fibrillation: A systematic review and meta-analysis of subgroups. Thrombosis. 2013;(01):01-18.

Insert PP, Xarelto (Rivaroxaban) Tablets; 2013.

Latha S, et al. Development and validation of RP-HPLC method for the estimation of erlotinib in pharmaceutical formulation. Arabian Journal of Chemistry. 2017;10(Suppl. 1):S1138-S1144.

Swartz ME, Krull IS. Analytical method development and validation. 1st ed. USA: CRC Press. 2018;1:92.

Pauli C, et al. Personalized in vitro and in vivo cancer models to guide precision medicine. Cancer Discovery. 2017;7(5):462-477.

Baldelli S, et al. Validation of an LC–MS/MS method for the simultaneous quantification of dabigatran, rivaroxaban and apixaban in human plasma. Bioanalysis. 2016;8(4):275-283.

Yu B, Yang H. Evaluation of different estimation methods for accuracy and precision in biological assay validation. PDA Journal of Pharmaceutical Science and Technology. 2017;71(4):297-305.

Ganorkar SB, Dhumal DM, Shirkhedkar AA. Development and validation of simple RP-HPLC-PDA analytical protocol for zileuton assisted with Design of Experiments for robustness determination. Arabian Journal of Chemistry. 2017;10(2):273-282.

Al-Rimawi F. Development and validation of a simple reversed-phase HPLC-UV method for determination of malondialdehyde in olive oil. Journal of the American Oil Chemists' Society. 2015;92(7):933-937.

Ershadi S, Shayanfar A. Are LOD and LOQ reliable parameters for sensitivity evaluation of spectroscopic methods? Journal of AOAC International. 2018;101(4):1212-1213.