Physical Characteristics Of Ofloxacin Tablets sold in Uyo and Quantitative Assay by Novel Ion-Pair Complexation Technique

Main Article Content

Arnold C. Igboasoiyi
Marlene D. Ekpo
Amarachi P. Egeolu

Abstract

Ofloxacin is a flouroquinoline antibiotic frequently prescribed for the treatment of various bacterial infections. Quality assessments were carried out on ten brands of ofloxacin tablets, purchased randomly from various pharmacies in Uyo, Akwa Ibom State, Nigeria and coded A-J. These were subjected to standard physical tests to determine their respective disintegration times, weight uniformity, hardness, friability characteristics and dissolution profiles using standard methods. Quantitative assay was by a spectrophotometric measurement of the ion-pair complex of the drug with bromothymol blue (BTB). All the brands met requirements for weight uniformity and disintegration characteristics. All the brands except brands B, E and F passed the USP specification of 80% dissolution in 30 minutes for uncoated ofloxacin tablets. The f1 and f2 values of the various brands, in comparison with the innovator product (brand I) showed that brands A,B,D,E,H and J could be used interchangeably with brand I. Brands F and J showed suboptimal friability values. Brand B showed suboptimal hardness value. The calibration curve for reference ofloxacin with BTB at 410 nm was linear over a concentration range of 0.00-20.00 ?g/ml. The variation of absorbance with concentration showed excellent correlation with coefficient of correlation (r) of 0.9999 and coefficient of determination (r2) of value 0.9998. All the brands met the USP requirement for content of active ingredient (100.0-110.0%). The recovery of the drug from tablets ranged between 97.54-100.3%. The spectrophotometric assay method used is a simple, sensitive, economical and extraction-free method. It is recommended for routine quantitative analysis of ofloxacin tablets.

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Igboasoiyi, A. C. ., Ekpo, M. D. ., & Egeolu, A. P. . (2020). Physical Characteristics Of Ofloxacin Tablets sold in Uyo and Quantitative Assay by Novel Ion-Pair Complexation Technique. Nigerian Journal of Pharmaceutical and Applied Science Research, 7(3), 33–38. Retrieved from https://nijophasr.net/index.php/nijophasr/article/view/246
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Articles
Author Biographies

Arnold C. Igboasoiyi

Department of Pharmaceutical and Medicinal Chemistry, Faculty of Pharmacy, University of Uyo, Uyo, Akwa Ibom State, Nigeria.

Marlene D. Ekpo

Department of Pharmaceutical and Medicinal Chemistry, Faculty of Pharmacy, University of Uyo, Uyo, Akwa Ibom State, Nigeria.

Amarachi P. Egeolu

1Department of Pharmaceutical and Medicinal Chemistry, Faculty of Pharmacy, University of Uyo, Uyo, Akwa Ibom State, Nigeria.

References

Adegbolagun OA, Olalade, OA Osumah, SE (2007). Comparative Evaluation of the Biopharmaceutical and Chemical Equivalence of some Commercially Available Brands of Ciprofloxacin Hydrochloride Tablets. Tropical Journal of Pharmaceutical Research, 6 (3): 737-745.

Anderson AC, Mackey TK, Attaran A BA (2016). Mapping of Health Communication and Education Strategies Addressing the Public Health Dangers of Illicit Online Pharmacies. Journal of Heath Communication 21,(4): 397-407.

Andersson MI, MacGowan AP (2003). Development of the Quinolones. Journal of Antimicrobial Chemotherapy, 51 (1): 1-11.

Bayerdorffer E, Simon TH, Bastlein CH, Ottenjann R, Kasper G (1987). Bismuth/ofloxacin combination for duodenal ulcer. Lancet 2:1467–1468

Bearden DT, Danziger LH (2001). Mechanism of Action of and Resistance to Quinolones. Pharmacotherapy, 21 (10): 224-232.

Bébéar C, De Barbeyrac B (2009). Genital Chlamydia trachomatis Infections. Clinical Microbiology and Infection, 15 (1): 4-10.

Bosques-Padilla FJ, Garza-Gonzalez E, Calderon-Lozano IE, Reed?SanRoman G, Suárez MDA, Valdovinos?Díaz MA, Orozco?Gámiz A, Blancas?Valencia JM, Tamayo?de la Cuesta JL (2004) . Open, randomized multicenter comparative trial of rabeprazole, ofloxacin and amoxicillin therapy for helicobacter pylori eradication: 7 vs. 14 day treatment. Helicobacter. 9:417-421. http://www.ncbi.nlm.nih.gov/pubmed/15361080?dopt=AbstractPlus.

British Pharmacopoeia (2015). British Pharmacopoeia Commission, London, Appendix XIIC, p. 371.

Drlica K, Zhao X. (1997). DNA gyrase, topoisomerase IV, and the 4-quinolones. Microbiol Mol Biol Rev. 61(3):377-392.

Drugs.com (2018). Ofloxacin Monograph for Professionals https://www.drugs.com/monograph/ofloxacin.html Retrieved 15/06/2018

Duggirala A, Joseph J, Sharma S, Nutheti R, Garg P, Das, T. (2007). Activity of Newer Fluoroquinolones Against Gram-Positive and Gram-Negative Bacteria Isolated from Ocular Infections: An In Vitro Comparison. Indian Journal of Opthalmology, 55(1): 15-19.

Fakheri H, Bari Z, Aarabi M, Malekzadeh R. Helicobacter pylori eradication in West Asia: a review. World J Gastroenterol. 2014; 20(30):10355-67. http://www.ncbi.nlm.nih.gov/pubmed/25132752?dopt=AbstractPlus http://www.pubmedcentral.nih.gov/picrender.fcgi?tool=pmcentrez&artid=4130843&blobtype=pdf

Jaman M, Chowdhury AA , Rana AA, Masum SM, Ferdous T, Rashid MA, Karim. MM (2015). In vitro evaluation of Ciprofloxacin Hydrochloride. Bangladesh J. Sci. Ind. Res. 50(4), 251-256.

Jantratid E, Janssen, N, Reppas, C, Dressman JB (2008). Dissolution Media Simulation Conditions in the Proximal Human Gastrointestinal Tract: An Update. Pharmaceutical Resources, 25: 1663-1676.

Igboasoiyi AC, Offor AC, Egeolu AP (2018). Quality Assessment of Various Brands of Ciprofloxacin Hydrochloride Tablets Sold In Uyo Metropolis. Nigerian Journal of Pharmaceutical and Applied Science Research, 7(2): 89-93, May 2018 (ISSN 1485-8059 Available at www.nijophasr.com)

Issa YM, Abdel-Gawad FM., Abou MA, Hussein HM (1997. “Spectrophotometric detetmination of ofloxacin and lomefloxacin hydrochloride with some sulphonthalein dyes”, Analytical Letters. 30: 2071-2084.

Mansour-Ghanaei F, Joukar F, Naghipour MR Forouhari A, and Saadat SMS (2015). Seven-day quintuple regimen as a rescue therapy for Helicobacter pylori eradication. World J Gastroenterol, 21:661-6. http://www.ncbi.nlm.nih.gov/pubmed/25593496?dopt=AbstractPlus http://www.pubmedcentral.nih.gov/picrender.fcgi?tool=pmcentrez&artid=4292302&blobtype=pdf

Mathur SC, Kumar Y, Murugesan N, RathodeYKS, Sethi PD (1992). “Spectrophotometric determination of ofloxacin in pharmaceutical formulations”. Indian Drugs. 9: 376-377

Minakari M, Davarpanah Jazi AH, Shavakhi A, Moghareabed N, Fatahi F (2010). A randomized controlled trial: efficacy and safety of azithromycin, ofloxacin, bismuth, and omeprazole compared with amoxicillin, clarithromycin, bismuth, and omeprazole as second-line therapy in patients with Helicobacter pylori infection. Helicobacter. 15:154-9.

http://www.ncbi.nlm.nih.gov/pubmed/20402818?dopt=AbstractPlus

Nouira, S., Marghli, S., Belghith, M., Besbes, L., Elatrous, S. and Abroug, F. (2001). Once Daily Oral Ofloxacin in Chronic Obstructive Pulmonary Disease Exacerbation Requiring Mechanical Ventilation: A Randomised Placebo-Controlled Trial. The Lancet. 358(9298): 2020-2025.

Patel P. U., Suhagia B. N., Patel M. M., Patel G. C. and Patel G. N.(2007) “Spectrophotometric determination of ofloxacin with citric acid-acetic anhydride” The Indian Pharmacist. 6:59-61.

Sastry C. S., Rama R. K. and Siva P. D. (1995) “Extractive spectrophotometric determination of some fluoroquinolones derivatives in pure and dosage forms,” Talanta. 42: 311-31.

Shah VP (2001). Dissolution: a quality control test vs a bioequivalent test. Dissolution Technologies 8(4): 1–2.

Stamm WE, Norrby SR (2001). Urinary Tract Infections: Disease Panorama and Challenges. The Journal of Infectious Diseases. 183(1): S1-S4.

Ubajaka CF, Obi-Okaro AC, Emelumadu OF, Azumarah MN, Ukegbu AU, Ilikannu SO (2016). Factors Associated with Drug Counterfeit in Nigeria: A Twelve Year Review. British Journal of Medicine & Medical Research. 12(4):1-8, 2016, Article no.BJMMR.21342 ISSN: 2231-0614, NLM ID: 101570965 SCIENCEDOMAIN international www.sciencedomain.org

Uivarosi V (2013). Metal Complexes of Quinolone Antibiotics and their Applications. An Update. Molecules, 18(9): 11153-11197.

United States Food and Drug Administration, Center for Drug Evaluation and Research (1997). Guidance for industry: Dissolution testing of immediate release solid oral dosage forms, available at: http://www.fda.gov/cder/Guidance/1713bp1.pdf.

United States Pharmacopoeia National Formulary USP 37NF 32. (2014). Ofloxacin Official Monograph, United States Pharmacopeial Convention 12601. Twinbrook, Parkway, Rockville MD 208523, 3:4046-4048.

Weaver C, Whalen J (2012). How Fake Cancer Drugs Entered U.S. The Wall Street Journal. https://www.wsj.com/articles/SB10001424052702303879604577410430607090226. Retrieved 26/04/2018