Comparison of Chemical Parameters of Different Brands of Rivaroxaban Tablets Available in Pakistan
Abstract
A major issue is that the dissolution and assay methods are not discussed in any pharmacopeia, so the assay method was developed following the guidelines of the Food and Drug Administration. The analytical and dissolution methods were developed and validated in accordance with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use’s (ICH) guidelines. This study aims to discover the presence of counterfeit or substandard drugs in the market, to classify the most compliant brands, and to ascertain the appropriateness of interchangeability. Four different brands of rivaroxaban were selected in order to perform different quality control tests, which included the analytical, dissolution, and assay methods in accordance with the guidelines of the United States Pharmacopeia. The four chosen brands were tested and the results were found to be compliant with chemical parameters such as dissolution, content uniformity, and assay. Hence, it can be concluded that rivaroxaban 10 mg tablets, manufactured in Pakistan by leading pharmaceutical companies, are consistent in quality and can be easily interchangeable.
Keywords: rivaroxaban, anticoagulant, quality control parameters.
Full Text:
PDFReferences
ÇELEBIER M., REÇBER T., KOÇAK E., and ALTINÖZ S. RP-HPLC method development and validation for estimation of rivaroxaban in pharmaceutical dosage forms. Brazilian Journal of Pharmaceutical Sciences, 2013, 49(2): 359-366. https://doi.org/10.1590/S1984-82502013000200018
REDDY G. S., REDDY S. L. N. P., and REDDY L. S. K. Development and Validation of HPLC-MS/MS Method for Rivaroxaban Quantitation in Human Plasma Using Solid Phase Extraction Procedure. Oriental Journal of Chemistry, 2016, 32(2): 1145-1154. http://dx.doi.org/10.13005/ojc/320240
RAO V. B. and REDDY S. A Novel RP-HPLC Method for the Quantification of Rivaroxaban in Formulations. International Journal of Pharma and Bio Sciences, 2013, 4(4): 756–764. https://ijpbs.net/abstract.php?article=Mjc2Mw==
VAGHELA D., and 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): 383-386. https://innovareacademics.in/journal/ijpps/Vol6Issue6/9666.pdf
KASAD P. A., & MURALIKRISHNA K. S. Design and Validation of Dissolution Profile of Rivaroxaban by Using RP-HPLC Method in Dosage Form. Asian Journal of Pharmaceutical Analysis, 2013, 3(3): 75-78. https://indianjournals.com/ijor.aspx?target=ijor:ajpa&volume=3&issue=3&article=001
SAMAMA M. M., CONTANT G., SPIRO T. E., PERZBORN E., LE FLEM L., GUINET C., GOURMELIN Y., ROHDE G., and MARTINOLI J.-L. Laboratory assessment of rivaroxaban. Thrombosis Journal, 2013, 11: 11. https://dx.doi.org/10.1186%2F1477-9560-11-11
ZHANG Y., QIAN Q., QIAN G., and SUN G. Laboratory monitoring of rivaroxaban and assessment of its bleeding risk. British Journal of Biomedical Science, 2016, 73(3): 134-139. https://doi.org/10.1080/09674845.2016.1195151
EL-AZIZ H. A., IBRAHIM F., SHARAF EL-DIN M., and FATHY M. E. Micellar High Performance Liquid Chromatographic Determination of a Binary Mixture of Rivaroxaban and Clopidogrel and Application to Biological Fluids. Pharmaceutica Analytica Acta, 2016, 7(9): 1000506. https://doi.org/10.4172/2153-2435.1000506
PRAJAPATI A. M., & PATEL H. A. Simultaneous RP-HPLC Method Development and Validation of Clopidogrel and Rivaroxaban in Synthetic Mixture. Arun and Patel, International Journal of Pharmacy, 2015, 5(2): 610-613. https://www.pharmascholars.com/articles/simultaneous-rphplc-method-development-and-validation-of-clopidogrel-and-rivaroxaban-in-synthetic-mixture.pdf
ANTONIOU S. Rivaroxaban for the treatment and prevention of thromboembolic disease. Journal of Pharmacy and Pharmacology, 2015, 67(8): 1119–1132. https://doi.org/10.1111/jphp.12387
KUBITZA D., BECKA M., MUECK W., HALABI A., MAATOUK H., KLAUSE N., LUFFT V., WAND D. D., PHILIPP T., and BRUCK H. Effects of renal impairment on the pharmacokinetics, pharmacodynamics and safety of rivaroxaban, an oral, direct Factor Xa inhibitor. British Journal of Clinical Pharmacology, 2010, 70(5): 703-712. https://doi.org/10.1111/j.1365-2125.2010.03753.x
SHYAMASAKHI P. D., SANIA K. M., MEENA N. D., BIKRAM T., and TARINITA L. Rivaroxaban, a direct factor XA inhibitor: a drug update. International Journal of Pharmaceutical Sciences and Research, 2015, 6(8): 3186-3191. https://doi.org/10.13040/IJPSR.0975-8232.6(8).3186-91
Refbacks
- There are currently no refbacks.
