Quality Assessment of Antibiotic Oral Drug Formulations Marketed In Katsina State, Nigeria

Authors

  • Mukhtar Gambo Lawal Department of Microbiology, Umaru Musa Yar’adua University, P.M.B 2218 Katsina,Nigeria
  • Muhammad Dauda Mukhtar Microbiology Department, Bayero University, P. M. B. 3011, Kano, Nigeria
  • Abdulkadir Magaji Magashi Microbiology Department, Bayero University, P. M. B. 3011, Kano, Nigeria

DOI:

https://doi.org/10.22270/ajprd.v7i6.615

Keywords:

Antibiotics, chemical quality, API, substandard drugs, HPLC

Abstract

There are increasing reports on the high incidence of substandard drugs, especially in developing countries.Pharmaceutical products have been reported to contain either no, low, or excessive amounts of the active pharmaceutical ingredient (API). Inview of the above, 112 samples of six different antibiotic oral drug formulations were evaluated for chemical quality by assessing the presence and the percentage content of the stated active pharmaceutical ingredients using validated HPLC assay as described in the official monograph of the British and United Stated pharmacopoeia. The result indicates that 43 (38.4%) had active ingredients outside the set pharmacopoeial limit and therefore were non-compliant to the BP and the USP specifications for percentage content.  Ampiclox and Cotrimoxazole had the highest proportion of samples with active ingredient outside the pharmacopoeial limit, and in three samples (one Augmentin and two Ampiclox), no active ingredient was detected. The presence of API lower than the claimed content declared on the packaging was the primary cause of non-compliance. The potential implications of the use of substandard drugs are treatment failure and the development of drug-resistance.

 

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Author Biographies

Mukhtar Gambo Lawal, Department of Microbiology, Umaru Musa Yar’adua University, P.M.B 2218 Katsina,Nigeria

Department of Microbiology, Umaru Musa Yar’adua University, P.M.B 2218 Katsina, Nigeria

Muhammad Dauda Mukhtar, Microbiology Department, Bayero University, P. M. B. 3011, Kano, Nigeria

Microbiology Department, Bayero University, P. M. B. 3011, Kano, Nigeria

Abdulkadir Magaji Magashi, Microbiology Department, Bayero University, P. M. B. 3011, Kano, Nigeria

Microbiology Department, Bayero University, P. M. B. 3011, Kano, Nigeria

References

1. Shakoor O, Taylor RB, Behrens RH. Assessment of the Incidence of Substandard Drugs in Developing Countries. Tropical Medicine and International Health. 1997; 2(9):839-845.
2. Taylor RB, Shakoor O, Behrens RH, Everard M, Low AS, Wangboonskul J, Reid RG, Kolawole JA. Pharmacopoeial quality of drugs supplied by Nigerian pharmacies. Lancet. 2001; 357:1933-1936.
3. Kelesidis T, and Falagas ME. Substandard/counterfeit antimicrobial drugs. Clinical Microbiology Review. 2015; 28(2):443-464.
4. Osei-Safo DHA, Egbo H, Nettey DY, Konadu and I. Addae-Mensah. Evaluation of the Quality of Some Antibiotics Distributed in Accra and Lagos. International Journal of Pharmaceutical Science and Research. 2016; 7(5):1991-2000.
5. Akunyili D, Counterfeit and Substandard Drugs, Nigeria’s experience: Implications, Challenges, Actions, and Recommendations” Excerpts from the Meeting for Key Interest Groups on Health Organized by the World Bank in Washington D.C on 10th -11th March 2005.
6. Udobi Chinweizu Ejikeme and Onaolapo, Josiah Ademola. Comparison of Microbiological and Chemical Assay Methods used in the Quality Assessment of Ampicillin Suspensions Sold in Zaria-Nigeria. Nigerian Journal of Pharmaceutical and Applied Science Research. 2016; 5(1):69-72
7. Nishant A. Dafale N, Uttam P. Semwal, Rupak K. Rajput, G.N. Singh. Selection of appropriate analytical tools to determine the potency and bioactivity of antibiotics and antibiotic resistance Journal of Pharmaceutical Analysis. 2016; (6):207–213
8. Fadeyi, Ifeyinwa, Mirza Lalani, Naiela Mailk, Albert Van Wyk, and Harparkash Kaur. Quality of the Antibiotics—Amoxicillin and Co-Trimoxazole from Ghana, Nigeria, and the United Kingdom. American Journal of Tropical Medicine and Hygiene. 2015; 92(6):87–94.
9. World Health Organization. (2015). WHO Model Lists of Essential Medicines.
10. Kolawole JA, Olurunmi PO, Okeniyi SO, and Shawrpshaka YJ. Quality and Availability of Ampicillin Products in Jos, Nigeria. Nigerian Journal of Pharmacy. 2002; 33:27-42.
11. United States Pharmacopoeia (2018).National Formulary 36 (U.S.P. 41, N.F. 27) United States Pharmacopoeial Convention Inc., Rockville, MD.
12. British Pharmacopoeia (2017). The Stationery Office, London, pp.V396 _V402
13. Newton PN, Green MD, Fernandez FM, Day NPJ, White NJ. Counterfeit anti-infective drugs. Lancet Infectious Disease. 2006; 6: 602-613.
14. Grace Frimpong, KwabenaOfori-Kwakye, Noble Kuntworbe, Kwame OheneBuabeng, YaaAsantewaaOsei, Mariam El Boakye-Gyasi, and OfosuaAdi-Dako. Quality Assessment of Some Essential Children’s Medicines Sold in Licensed Outlets in Ashanti Region, Ghana. Hindawi Journal of tropical medicine. 2018;
15. Okeke IN, and Lamikankra A. Quality and Bioavailability of Ampicillin Capsules Dispensed in a Nigerian Semi-urban Community. African Journal of Medicine and Medical Sciences. 2001; 30(1-2):47-51.
16. Iwuagwu MA, and Onyeonwu N. In Vitro Assessment of Ampicillin Capsules Marketed in Nigeria. International Journal of Pharmacy Practice. 1992; 3(1):169-171.
17. Mukhtar MD, Maryam IA, and Adoum AO. Quality Assessment of Some Brands of Ampicillin Oral Formulations on Sale in Some Parts of Kano by Thin Layer Chromatography and Microbiological Techniques. Journal of Research in Biosciences. 2006; 2(1).
18. Kyriacos S, Mrouch M, Chachine RP, and Khouzam O. Quality of Amoxicillin Formulations in some Arab Countries. Journal of Clinical Pharmaceutical Therapy. 2008; 33(4): 375-379. DOI: 10.1111/j.1365-2710.2008.00926.x.
19. Olanrewaju Odulaja J, Azubuike C. Paul1, and Akinleye M. Olusola. Quality assessment of amoxicillin-clavulanate potassium tablets in Lagos, Nigeria. Journal of Chemical and Pharmaceutical Research. 2012; 4(12): 5032-5038
20. Mohamed N. El Attug, Amal Ammar, SeragTunsi, SohailElmjrab, Shukri Al-Sharif, Abdulmonem Gobassa, Emhemmed Elgallal. Pharmaceutical Evaluation of an Augmentin Brand Manufactured in Different Countries. American Journal of Pharmacy and Pharmacology. 2015; 2(4):35-44.
21. Henry Nettey, Grace Lovia Allotey-Babington, Philip Debrah, OfosuaAdi-Dako, Manal Shaick, Isaac Kintoh, Francis Arnansi, MakafuiNyagblordzro, Marvin Holison. The Quality and in Vitro Efficacy of Amoxicillin/Clavulanic Acid Formulations in the Central Region of Ghana. Pharmacology & Pharmacy. 2014; 5:49-60.
22. Mweemba W. Evaluation of the quality of anti Tuberculosis drugs in Lusaka, Zambia. Medical Journal of Zambia. 2015; 42(4):144-149

Published

2019-12-15

How to Cite

Lawal, M. G., Mukhtar, M. D., & Magashi, A. M. (2019). Quality Assessment of Antibiotic Oral Drug Formulations Marketed In Katsina State, Nigeria. Asian Journal of Pharmaceutical Research and Development, 7(6), 6–10. https://doi.org/10.22270/ajprd.v7i6.615