ABSTRACT
A simple and sensitive high-performance thin layer chromatography (HPTLC) method was developed and validated as per the International Council for Harmonization (ICH) guidelines for the simultaneous determination of amoxicillin (AMX) and clavulanic acid (CLA) combinations in tablet formulations. Chromatography was performed on precoated glass plates with normal phase silica gel 60 F254. The mobile phase was acetone:ethyl acetate:glacial acetic acid:water (11:9:4:2 (v/v)). The plate was scanned at a wavelength of 428 nm after derivatization with ninhydrin. The validation of the method revealed that the linearity range lies between 400 and 1200 ng/band for AMX and 100-300 ng/band for CLA, with coefficients of determination of 0.9997 and 0.9966, respectively. Recoveries in standard addition accuracy studies were 100.3 % for AMX and 96.75 % for CLA. The limit of detection (LOD) and limit of quantitation (LOQ) of the developed method are 20.3 ng/band and 61.6 ng/band for AMX and 18.5 ng/band and 56.2 ng/band for CLA, respectively. The new, novel high-performance thin layer chromatography (HPTLC) method that was successfully developed in this study was applied for the simultaneous determination of AMX and CLA in their fixed-dose tablet dosage forms obtained from retail pharmacies and offered comparable results with the official British Pharmacopoeial high-performance liquid chromatography (HPLC) method.
ABSTRACT
BACKGROUND: Despite medicines are a major contributor to the health and well-being of the community, irrational use of medicines is being a serious public health crisis with significant harmful implications for patients, healthcare systems, and communities as a whole. OBJECTIVE: This study was aimed at evaluating the rational use of medicine using the World Health Organization/Network of Rational Use of Drugs (WHO/INRUD) core drug use indicators at Teda and Azezo health centers of Gondar town, northwest Ethiopia. METHODS: A cross-sectional study was conducted among 1200 prescription papers retrospectively, and 60 patients prospectively at two health centers of Gondar town, northwest Ethiopia from May 01/2019 to April 30/2020. The data were collected using a standard data collection checklist. Data were analyzed using SPSS® version 24. The data were analyzed descriptively by using mean, frequency, and proportion. RESULTS: Prescribing indicators: From a total of 2595 prescribed medicines, 94% of them were prescribed by generic name; percent encounters with injection was 9.5±0.28%, percent encounters with antibiotics was 73.85±0.35%, and 100% of medicines were prescribed from the essential medicine list of Ethiopia. Patient care indicators: Only 16.7% of the patients knew the correct dosage of their medications, and 17.5% of dispensed medicines were adequately labeled. From the prescribed medications, only 77.17% were actually dispensed. Average consultation and dispensing time were 5.35 minutes and 40.24 seconds, respectively. Facility-specific indicators: Only 83.5% of key medicines were available in the health centers. CONCLUSION: According to the WHO/INRUD core drug use indicators, rational medicine use is not achieved in terms of most components of the prescribing, patient care, and facility-specific indicators. Therefore, both health centers should work towards promoting the rational use of medicines.