Generic placeholder image

Current Pharmaceutical Analysis


ISSN (Print): 1573-4129
ISSN (Online): 1875-676X

Research Article

Assessment of Purity Parameters of Generic and Brand Name Losartan Potassium

Author(s): Patricia Mattiazzi, Denise Bohrer*, Carine Viana and Emilene Becker

Volume 17, Issue 1, 2021

Published on: 11 September, 2019

Page: [129 - 139] Pages: 11

DOI: 10.2174/1573412915666190911091218

Price: $65


Background: Generic products must be bioequivalent to the innovator brand product. Nevertheless, in addition to meeting bioequivalence standards, attention must be paid to the content of the active substance and contaminants in generic drugs.

Objectives: This study compared the pharmaceutical quality of four generic losartan potassium formulations with the brand-name product: Cozaar®.

Methods: The United States Pharmacopeia (USP) losartan potassium standard was used as reference material. The products tested (all 50 mg formulations) included four generic tablet formulations and the innovator brand product Cozaar®. Active substance content, organic impurities, and elemental impurities were assessed following the USP monograph for losartan potassium tablets and USP Chapter <233> on Elemental Impurities.

Results: The results showed that three of the four generic products had low content of the active ingredient. The values ranged from 86.4 to 93.8%, being acceptable not below 95% of the labeled amount. Organic impurities were not detected in any of the products, and of the 13 elemental impurities tested, only four elements were detected. The elemental impurities Cr, Ni, Cu, and As were, however, in amounts within the limits established by the USP monograph. The only concern on the generic drugs analyzed was the low content of the active ingredient in 75% of the products.

Conclusion: Since losartan is a drug of continuous use, lower content of the active ingredient may go unnoticed by the users of the generic product and entailed clinical consequences during long-term therapy.

Keywords: Losartan potassium, generic drugs, purity, organic impurities, elemental impurities, FDA.

Graphical Abstract
Godman, B.; Wettermark, B.; van Woerkom, M.; Fraeyman, J.; Alvarez-Madrazo, S.; Berg, C.; Bishop, I.; Bucsics, A.; Campbell, S.; Finlayson, A.E.; Fürst, J.; Garuoliene, K.; Herholz, H.; Kalaba, M.; Laius, O.; Piessnegger, J.; Sermet, C. Schwabe. U.; Vlahovic-Palcevski, V.V.; Markovic-Pekovic,V.; Voncina, L.; Malinowska, K.; Zara, C.; Gustafsson, L.L. Multiple policies to enhance prescribing efficiency for established medicines in Europe with a particular focus on demand-side measures: findings and future implications. Front. Pharmacol., 2014, 5, 1-9.
Leclerc, J.; Blais, C.; Rochette, L.; Hamel, D.; Guénette, L.; Poirier, P. Impact of the Commercialization of Three Generic Angiotensin II Receptor Blockers on Adverse Events in Quebec, Canada: A Population-Based Time Series Analysis. Circ. Cardiovasc. Qual. Outcomes, 2017, 10(10)e003891
[] [PMID: 28974512]
Ripley, E.; Hirsch, A. Fifteen years of losartan: what have we learned about losartan that can benefit chronic kidney disease patients? Int. J. Nephrol. Renovasc. Dis., 2010, 3, 93-98.
[] [PMID: 21694934]
Kanavos, P.; Costa-Font, J.; Seeley, E. Competition in off-patent drug markets: issues, regulation and evidence. Econ. Policy, 2008, 23(55), 500-544.
Garattini, L.; Tediosi, F. A comparative analysis of generics markets in five European countries. Health Policy, 2000, 51(3), 149-162.
[] [PMID: 10720685]
FDA, Food and Drug Administration Generic Drugs: Questions & Answers ; March 20, 2019).
WHO, Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability.. 2017.
Chow, S.C. Bioavailability and Bioequivalence in Drug Development. Wiley Interdiscip. Rev. Comput. Stat., 2014, 6(4), 304-312.
[] [PMID: 25215170]
Davit, B.M.; Nwakama, P.E.; Buehler, G.J.; Conner, D.P.; Haidar, S.H.; Patel, D.T.; Yang, Y.; Yu, L.X.; Woodcock, J. Comparing generic and innovator drugs: a review of 12 years of bioequivalence data from the United States Food and Drug Administration. Ann. Pharmacother., 2009, 43(10), 1583-1597.
[] [PMID: 19776300]
Jia, J.Y.; Zhang, M.Q.; Liu, Y.M.; Liu, Y.; Liu, G.Y.; Li, S.J.; Lu, C.; Weng, L.P.; Qi, Y.L.; Yu, C. Pharmacokinetics and bioequivalence evaluation of two losartan potassium 50-mg tablets: A single-dose, randomized-sequence, open-label, two-way crossover study in healthy Chinese male volunteers. Clin. Ther., 2010, 32(7), 1387-1395.
[] [PMID: 20678685]
United States Pharmacopeia - USP USP, 2017. 232 Elemental Impurities – Limits. Chemical Tests. First Supplement 40–NF 35..
ICH, Impurities in new drug substances Q3A(R2) . ICH Harmonised Tripartite Guideline. . 2006. Guideline.pdf (Accessed October 20, 2018)
United States Pharmacopeia - USP. , 2017. Losartan Potassium Tablets.Official Monographs. Second Supplement to USP 40–NF 35. 2017.
United States Pharmacopeia - USP 2017. Elemental Impurities – Procedures. Chemical Tests. Second Supplement to USP 40–NF 35.
United States Pharmacopeia - USP; 2017.Validation of Compendial Procedures.General Information. First Supplement to USP 40–NF35..
United States Pharmacopeia - USP; 2017.Atomic Absorption Spectroscopy.Physical Tests. Second Supplement to USP 40–NF35..
Mattiazzi, P.; Bohrer, D.; Viana, C.; Nascimento, P.C.; Carvalho, L.M. Fast and easy method for the assay of TiO2 purity and its determination in drugs by flame atomic absorption spectrometry. J. Excip. Food Chem., 2018, 9(4), 100-105.
Arnet, I.; Altermatt, M.; Roggo, Y.; Schnetzler, G. Pharmaceutical quality of eight generics of ceftriaxone preparation for injection in Eastern Asia. J. Chemother., 2015, 27(6), 337-342.
[] [PMID: 25144924]

Rights & Permissions Print Export Cite as
© 2022 Bentham Science Publishers | Privacy Policy