QUALITY OF AMOXICILLIN TRIHYDRATE/POTASSIUM CLAVULANATE TABLETS COMMERCIALLY AVAILABLE IN LIBYAN PHARMACEUTICAL MARKET
DOI:
https://doi.org/10.22159/ijap.2023v15i5.48511Keywords:
UV-spectrophotometer, Quality, Amoxicillin, Potassium clavulantaeAbstract
Objective: The objective of this study was to compare the quality of the amoxicillin trihydrate/potassium clavulantae (co-clavimox) tablets those are locally available in Libyan pharmaceutical market manufactured by various pharmaceutical companies with United State Pharmacopeia (USP) standards.
Methods: The five popular brands (clavomid, augmentin, clavodar, clamoxin, and clavimox) of co-clavimox conventional tablet of 625 mg strength were chosen. The quality of commercial products was evaluated through the identification of the content of active pharmaceutical ingredients (APIs) using UV- Spectrophotometer.
Results: The results obtained showed that, the products clavomid, augmentin, and clavodar conformed to the USP standard limit for quantitative assay of active ingredients. Clamoxin passed the standard limit test with a slight deviation (<2%), while clavimox failed the test with values far below the acceptable range.
Conclusion: This study has been able to confirm that some generic brands of co-clavimox tablets available in the Libyan markets possess qualities below official recommendations. Therefore, there is an urgent need for constant monitoring of different brands of medications in the market to ensure their safety and quality.
Downloads
References
Uddin TM, Chakraborty AJ, Khusro A, Zidan BRM, Mitra S, Emran TB. Antibiotic resistance in microbes: history, mechanisms, therapeutic strategies and future prospects. J Infect Public Health. 2021;14(12):1750-66. doi: 10.1016/j.jiph.2021.10.020, PMID 34756812.
Klein EY, Van Boeckel TP, Martinez EM, Pant S, Gandra S, Levin SA. Global increase and geographic convergence in antibiotic consumption between 2000 and 2015. Proc Natl Acad Sci USA. 2018;115(15):E3463-70. doi: 10.1073/pnas.1717295115, PMID 29581252.
Chokshi A, Sifri Z, Cennimo D, Horng H. Global contributors to antibiotic resistance. J Glob Infect Dis. 2019;11(1):36-42. doi: 10.4103/jgid.jgid_110_18, PMID 30814834.
Mahmoud MA, Aldhaeefi M, Sheikh A, Aljadhey H. Community pharmacists perspectives about reasons behind antibiotics dispensing without prescription: a qualitative study. Biomed Res. 2018;29(21):18-29. doi: 10.4066/biomedicalresearch.29-18-1112.
Sreeja MK, Gowrishankar NL, Adisha S, Divya KC. Antibiotic resistance-reasons and the most common resistant pathogens–a review. Res J Pharm Technol. 2017;10(6):1886-90. doi: 10.5958/0974-360X.2017.00331.6.
World Health Organization. Member State mechanism on substandard/spurious/falsely-labelled/falsified/counterfeit medical products Report by the Director-General. World Health Organ Tech Rep S. 2017;20:1-42.
Zabala GA, Bellingham K, Vidhamaly V, Boupha P, Boutsamay K, Newton PN. Substandard and falsified antibiotics: neglected drivers of antimicrobial resistance? BMJ Glob Health. 2022;7(8):e008587. doi: 10.1136/bmjgh-2022-008587, PMID 35981806.
Kelesidis T, Falagas ME. Substandard/counterfeit antimicrobial drugs. Clin Microbiol Rev. 2015;28(2):443-64. doi: 10.1128/CMR.00072-14, PMID 25788516.
Aliyu AO, Garba S, Balogun LO, Awe FE. Quality assessment of some selected brands of amoxicillin clavulanate from pharmaceutical stores in Kaduna Metropolis, Nigeria. J Pharm Biol. 2021;16(2):33-40.
Huttner A, Bielicki J, Clements MN, Frimodt Møller N, Muller AE, Paccaud JP. Oral amoxicillin and amoxicillin-clavulanic acid: properties, indications and usage. Clin Microbiol Infect. 2020;26(7):871-9. doi: 10.1016/j.cmi.2019.11.028, PMID 31811919.
Brogden RN, Heel RC, Speight TM, Avery GS. Amoxycillin injectable: a review of its antibacterial spectrum, pharmacokinetics and therapeutic use. Drugs. 1979;18(3):169-84. doi: 10.2165/00003495-197918030-00001, PMID 387371.
Gordon C, Regamey C, Kirby WMM. Comparative clinical pharmacology of amoxicillin and ampicillin administered orally. Antimicrob Agents Chemother. 1972;1(6):504-7. doi: 10.1128/AAC.1.6.504, PMID 4680813.
Samira S, Mahmoud RS, Mehran D. Rapid and simple spectrophotometric method using feed forward back propagation and radial basis function neural networks for the simultaneous determination of amoxicillin and clavulanic acid in commercial tablet and human blood serum. Optik. 2012;247:167908.
Sutherland R, Croydon EAP, Rolinson GN. Amoxycillin: a new semi-synthetic penicillin. Br Med J. 1972;3(5817):13-6. doi: 10.1136/bmj.3.5817.13, PMID 4402672.
Gujral RS, Haque SM. Simultaneous determination of potassium clavulanate and amoxicillin trihydrate in bulk, pharmaceutical formulations and in human urine samples by UV spectrophotometry. Int J Biomed Sci. 2010;6(4):335-43. PMID 23675211.
Keij FM, Tramper Stranders GA, Koch BCP, Reiss IKM, Muller AE, Kornelisse RF. Pharmacokinetics of clavulanic acid in the pediatric population: a systematic literature review. Clin Pharmacokinet. 2022;61(5):637-53. doi: 10.1007/s40262-022-01116-3, PMID 35355215.
Nessa F, Al Zoubi H, Khan GA. Pharmaceutical equivalence study of amoxicillin/clavulanic acid salt tablets commercially available in UAE pharmaceutical market. Pharm Sci Asia. 2020;47(3):262-73. doi: 10.29090/psa.2020.03.019.0039.
Salvo F, De Sarro A, Caputi AP, Polimeni G. Amoxicillin and amoxicillin plus clavulanate: a safety review. Expert Opin Drug Saf. 2009;8(1):111-8. doi: 10.1517/14740330802527984, PMID 19236222.
Indrayanto G, Sa TK, Widjaja S. Simultaneous determination of amoxycillin trihydrate and clavulanate potassium in pharmaceutical preparations by thin-layer chromatography/densitometry. J AOAC Int. 2000;83(6):1493-6. doi: 10.1093/jaoac/83.6.1493, PMID 11128160.
Eissa MS, Darweish E, Elghobashy MR, Shehata MA. Rapid selective TLC-densitometry method for simultaneous determination of amoxicillin and flucloxacillin in their pure forms or in their pharmaceutical preparation. Anal Chem Lett. 2018;8(2):188-94. doi: 10.1080/22297928.2018.1424563.
Hancu G, Simon B, Kelemen H, Rusu A, Mircia E, Gyeresi A. Thin layer chromatographic analysis of beta-lactam antibiotics. Adv Pharm Bull. 2013;3(2):367-71. doi: 10.5681/apb.2013.059, PMID 24312862.
Petkova V, Tsvetkova DD, Obreshkova DP, Dimitrov M, Papanov S. Validation of TLC densitometric method for quality control of amoxicillin in dosage drug products. World J Pharm Pharm Sci. 2014;3(5):995-1008.
Unal K, Palabıyık IM, Karacan E, Onur F. Spectrophotometric determination of amoxicillin in pharmaceutical formulations. Turk J Pharm Sci. 2008;5(1):1-6.
Qader HA, Fakhre NA. Spectrophotometric determination of amoxicillin trihydrate in pure and pharmaceutical dosage forms. Ibn Al-Haitham J Pure Appl Sci. 2017;28(3):142-53.
Cruz JC, Nascimento MA, Teixeira AM, Oliveira AF, Lopes RP. Development of a method for the determination of amoxicillin in capsules by potentiometric titration. JCEC 2018;4(2):234-9. doi: 10.18540/jcecvl4iss2pp0234-0239.
Sani AA, Maidugu HG, Ilyas M. Comparative quantitative study of different brands of amoxicillin (500 mg) tablet marketed in Maiduguri Metropolis, Nigeria. J Natl Sci. 2014;4(24):109-23.
Alotaibi N, Overton S, Curtis S, Nickerson JW, Attaran A, Gilmer S. Toward point-of-care drug quality assurance in developing countries: comparison of liquid chromatography and infrared spectroscopy quantitation of a small-scale random sample of amoxicillin. Am J Trop Med Hyg. 2018;99(2):477-81. doi: 10.4269/ajtmh.17-0779, PMID 29893196.
Choundikar MY, Nitave SA, Katageri AR. Calibration curve of amoxicillin trihydrate in different solvents. World J Pharm Pharm Sci. 2015;4(2):286-93.
Suliman MB, El-Hddad S. Characterization of chemical constituents of Adansonia digitata L. using GC-MS and LC-MS/QTOF and their in vitro anti-cervical cancer effects Trop J. Nat Prod Res. 2023;7(6):3191-7.
Hancu G, Neacşu A, Papp LA, Ciurba A. Simultaneous determination of amoxicillin and clavulanic acid in pharmaceutical preparations by capillary zone electrophoresis. Braz J Pharm Sci. 2016;52(2):281-6. doi: 10.1590/S1984-82502016000200006.
Khan AN, Khar RK, Ajayakumar PV. Diffuse reflectance near infrared-chemometric methods development and validation of amoxicillin capsule formulations. J Pharm Bioallied Sci. 2016;8(2):152-60. doi: 10.4103/0975-7406.175973, PMID 27134469.
Tripathi GK, Singh S, Gupta M. UV spectroscopy technique for analysis of amoxicillin trihydrate in pH stimuli sensitive formulation. Pharm Sin. 2014;5(1):29-33.
Giang DH, Hoang VD. Comparative study of RP-HPLC and UV spectrophotometric techniques for the simultaneous determination of amoxicillin and cloxacillin in capsules. J Young Pharm. 2010;2(2):190-5. doi: 10.4103/0975-1483.63168, PMID 21264124.
Dadi M, Yasir M. Spectroscopy and spectrophotometry: Principles and applications for colorimetric and related other analysis. Colorimetry Intech Open. 2022. doi: 10.5772/intechopen.101106.
Ahmed MS, Mohamed J, Aoor G. Quantitative assay of aspirin (acetylsalicylic acid) and heavy metals as an impurity in Iraq’s market aspirin tablets using different analytical methods. Int J Appl Pharm. 2018;10(5):167-72.
Gyamcho TB, Asit K, Tanmoy B. Validation, stability studies, and simultaneous estimation of co-encapsulated curcumin, epigallocatechin gallatenanoformulation by RP-HPLC method. Int J Appl Pharm. 2022;14(6):186-95.
Suliman MB, Awatif AM. Determination of sennosides a and b in sudanese medicinal plant senna alexandrina pods and leaves using reverse-phase high-performance liquid chromatography. AJMAP. 2019;5(1):39-45.
Siti Morin S, Fatimah A, Muchlisyam. Simultaneous determination of amoxicillin and clavulanate potassium in dry syrup by derivative spectrophotometry. Int J PharmTech Res. 2016;7(1):79-89.
USP. National formulary 35. NF. The United State Pharmacopeial Convention, 12601 Twinbrook Parkway, Rockville. Vol. 2792. The United States Pharmacopeia 40; 2017. p. MD20852, 2.
Published
How to Cite
Issue
Section
Copyright (c) 2023 SANADELASLAM EL-HDDAD, MOHAMMED B. SULIMAN
This work is licensed under a Creative Commons Attribution 4.0 International License.