A Quality Control Survey of Antimicrobial Drug Products Hawked in Kisumu County, Kenya

Abstract

The quality of antimicrobial drugs is vital for patient safety. Under different climatic conditions, antimicrobial drugs stability may be compromised, which might lower their potency. This study aimed to determine the quality of antimicrobial drug products hawked in Kisumu County. Twenty-five antimicrobial drug samples, consisting of 7 amoxicillin capsules, 10 cotrimoxazole tablets, 3 doxycycline capsules, 3 ampicillin/cloxacillin capsules, and 2 phenoxymethyl penicillin (Pen V) tablets, were obtained using a convenient sampling technique. The samples were obtained from open-air markets in Kisumu County comprising Ahero, Sondu, Katito, Awasi, and the Kisumu Bus Station. Quality control tests (identification, weight variation, assay, dissolution and microbial load) were carried out on the samples according to the United States Pharmacopoeia (USP) (2024) specifications. System suitability tests were conducted for HPLC as prescribed in the USP to ensure the reliability and validity of the results. Antibiotic samples were identified using HPLC retention times, while UV spectroscopy was used to complement HPLC identification for doxycycline, amoxicillin and Pen V-containing drug samples. Weight variation was assessed using the percentage weight deviation approach for tablets and capsules. Chromatographic assay of the drug products was achieved by A Merck Hitachi High-performance liquid chromatographic system (Tokyo, Japan) equipped with an ultraviolet detector. Chromatographic separation was achieved using columns maintained at a temperature of 40 °C as specified in the USP (2024); a mobile flow rate of 1 ml/min, injection volume of 10μL and UV detection were applied for all the samples analysed. Dissolution testing was done using the USP apparatus 1 and 2 as described in the USP NF-44. USP apparatus 1 (basket) was employed for amoxicillin-containing samples, while USP apparatus 2 (paddle) was used for the rest. All drug xviii samples were further tested for microbial load using Tryptone soya agar and Sabouraud dextrose agar media for bacteria and fungi respectively. Twenty-three (92%) of the 25 samples analysed complied with the USP (2024) specifications for identification, weight variation, assay, dissolution and microbial load. Additionally, the overlaid UV spectra of the drug products and the Chemical Reference Standards were concordant in respect to λmax, further confirming identity. Two (8%) samples containing ampicillin/cloxacillin complied with all the USP 2024 specifications except for weight variation (AMP1) and assay (AMP2). Despite the insanitary sale conditions, all the drug samples complied with the test for microbial load. This study did not investigate degradation, Although A countrywide comprehensive survey should be conducted to evaluate the extent of hawking of antimicrobial drugs and the impact it has on the development of antimicrobial resistance