COMPARATIVE STUDY OF SEVEN BRANDS OF LEVOFLOXACIN 500 MG FILM-COATED TABLET MARKETED IN YEMEN
Keywords:Levofloxacin, Quality control, Comparative study, Yemeni market
Objective: The objective of the current study was to evaluate the quality control parameters of seven brands of levofloxacin 500 mg film-coated tablet available in the Yemeni market.
Methods: Physicochemical parameters assay was performed for seven brands of levofloxacin 500 mg film-coated tablet. Each brand was subjected to official and unofficial in vitro quality control tests, including weight variation, thickness, hardness, friability, disintegration, dissolution, and content uniformity assay by High-Performance Liquid Chromatography (HPLC).
Results: Out of seven, six brands of levofloxacin 500 mg film-coated tablet passed official specified assay tests according to the United States Pharmacopeia (USP) specifications. They showed a similar profile of thickness ranged between±0.01 and 0.10%, friability ranged between 0.01% and 0.34%, disintegration time ranged between 3.00 and 15.00 min, dissolution percentage ranged between 90.650 and 103.05 and content uniformity ranged between 93.62 and 107.12%. Regarding weight variation and hardness, six brands passed the weight variation test and only three brands showed optimum range (10-20 kg) of hardness test. Only one brand failed to pass the weight variation test, and four brands failed to pass the optimum range (10-20 kg) of hardness.
Conclusion: There are no remarkable differences between the seven brands regarding in vitro quality control tests of content uniformity, thickness, friability, disintegration, and dissolution. Even though four brands were above the optimum range of hardiness, they showed complete disintegration and dissolution within the acceptable limit. Regular assessment of marketed drugs is required to ensure bioequivalent to their innovators.
Bano R, Gauhar S, Naqvi SBS, Mahmood S. Pharmaceutical evaluation of different brands of levofloxacin tablets (250 mg) available in local market of Karachi (pakistan). Int J Curr Pharm Res 2011;3:15-22.
Poornachandra TM, Prudviraj A, Robinah K, Roy A, Sivasubramanian L. Comparative in vitro bioavailability studies on different brands of levofloxacin tablets. Acta Sci Pharm Sci 2019;3:50-4.
Kumar TM, Srikanth G, Rao JV, Rao K. Development and validation of HPLC-UV method for the estimation of levofloxacin in human plasma. Int J Pharm Pharm Sci 2011;3:247-50.
Katakam L. Split-half tablets: a complete review for analytical testing. Asian J Pharm Clin Res 2019;12:27-38.
Dressman JB, Amidon GL, Reppas C, Shah VP. Dissolution testing as a prognostic
tool for oral drug absorption: immediate release dosage forms. Pharm Res 1998;15:11-22.
Alsaifi A. Comparative evaluation quality of different brands of ibuprofen 400 mg tablets available in yemeni’s market. Chronicle Pharm Sci 2018;2:724-36.
Alyahawi A, Abdulmajed A. Quality control assessment of different brands of ciprofloxacin 500 mg tablets in yemen. Univ J Pharm Res 2018;3:31-6.
Al-kershi FA, Othman GQ, Al-qadasi FA. Quality and stability of amoxicillin-potassium clavulanate drugs marketed in yemen: Influence of tropical storage conditions. J Chem Pharm Res 2016;8:160-16.
Chavan H, Chhabra G, Gujarathi N, Jadhav A. Comparative study of in-process and finished products quality control test for tablet and capsules according to pharmacopoeias. Asian J Pharm Res Dev 2018;6:60-8.
Deshpande RD, Gowda D, Mahammed N, Maramwar DN. Bi-layer tablets-an emerging trend: a review. Int J Pharm Sci Res 2011;2:25-34.
Hammami MM, Hussein RF, AlSwayeh R, Alvi SN. Eight enteric-coated 50 mg diclofenac sodium tablet formulations marketed in saudi arabia: in vitro quality evaluation. BMC Res Notes 2020;13:1-6.
Amin M, Rahman M. Study and impact evaluation of particle size distribution on physicochemical properties of three different tablet formulations through sieve technology. Int J Pharm Res Scholars 2014;3:448-63.
Guetchueng ST, Nnanga E. Quality control evaluation of brands of mebendazole 100 mg tablets on the illegitimate pharmacy outlets. Int J Pharm Pharm Sci 2014;6:355-7.
Kalakuntla R, Veerlapati U, Chepuri M, Raparla R. Effect of various super disintegrants on hardness, disintegration and dissolution of drug from the dosage form. J Adv Sci Res 2010;1:15-9.
Lachman L, Lieberman A. The theory and practice of industrial pharmacy. Indian ed. New Delhi: CBS Publication and Distributors; 2009. p. 67-8.
Commission BP, Council GM, Commission GBM. British pharmacopoeia. London: Her Majesty's Stationery Office; 2013.
United State Pharmacopeia and National Formulary USP 39-NF 34; The United States Pharmacopeial Convention, Inc: Rockville MD; 2016.
Gangwar S, Singh S, GarDFg G, Garg V, Sharma P. To compare the disintegrating property of papaya starch and sago starch in paracetamol tablets. Int J Pharm Pharm Sci 2010;2 Suppl 2:148-51.
Ali BA, Al-haddad MG, Areqi AA. Comparative evaluation of some commercial clopidogrel tablets available in yemen. Majalah Farmaseutik 2017;13:79.
Logoyda L, Kovalenko S, Abdel Megied AM, Zhulkevych I, Drapak I, Demchuk I, et al. Hplc method development for the analysis of bisoprolol in a combined dosage form containing bisoprolol and enalapril and in vitro dissolution studied. Int J Appl Pharm 2019;11:186-94.
Nigatu M, Mohammed F, Temesgen A. In vitro comparative study of different brands of pantoprazole sodium enteric-coated tablets marketed in addis ababa, ethiopia. Asian J Pharm Res Dev 2019;7:13-8.
Abatea K, Temesgen A, Nigatu M. Comparative in vitro evaluation of different brands of metformin hydrochloride film coated tablets marketed in addis ababa, ethiopia. Asian J Pharm Res Dev 2020;8:44-50.
Jakaria M, Mousa A, Parvez M, Zaman R, Sayeed M, Ali M. In vitro comparative study of different brands of dexamethasone tablet available in bangladesh. Int J Pharm Qual Assur 2016;7:24-8.
Sultana S, Hosen MS. In vitro comparative quality evaluation of different brands of esomeprazole tablets available in selected community pharmacies in dhaka, bangladesh. BMC Res Notes 2018;11:184.
Desta HK, Teklehaimanot TT. In vitro quality evaluation of generic ciprofloxacin tablets available in community pharmacies of dessie town, northeast ethiopia. J Generic Med 2020;1:1-8.
Kumar P, Ganure AL, Subudhi BB, Shukla S, Upadhyay P. Design and comparative in vitro and in vivo evaluation of starch-acrylate graft copolymer-based salbutamol sulphate sustained release tablets. Asian J Pharm Sci 2015;10:239-46.
Kumar D, Singh J, Antil M, Kumar V. Quality control of tablets: a review. Int J Univers Pharm Bio Sci 2016;5:53-167.
Giri TK. Comparative in vitro evaluation of conventional ibuprofen marketed formulation. J Pharm Sci Technol 2013;2:75-80.
Azubuike CP, Oluyase S. Physicochemical and bioequivalence studies on some brands of levofloxacin tablets registered in nigeria. Br J Pharm Res 2014;4:1976-87.