Effects of packaging and storage conditions on the quality of amoxicillin-clavulanic acid - an analysis of Cambodian samples.

BACKGROUND: The use of substandard and degraded medicines is a major public health problem in developing countries such as Cambodia. A collaborative study was conducted to evaluate the quality of amoxicillin-clavulanic acid preparations under tropical conditions in a developing country. METHODS: Amoxicillin-clavulanic acid tablets were obtained from outlets in Cambodia. Packaging condition, printed information, and other sources of information were examined. The samples were tested for quantity, content uniformity, and dissolution. Authenticity was verified with manufacturers and regulatory authorities. RESULTS: A total of 59 samples were collected from 48 medicine outlets. Most (93.2%) of the samples were of foreign origin. Using predetermined acceptance criteria, 12 samples (20.3%) were non-compliant. Eight (13.6%), 10 (16.9%), and 20 (33.9%) samples failed quantity, content uniformity, and dissolution tests, respectively. Samples that violated our observational acceptance criteria were significantly more likely to fail the quality tests (Fisher's exact test, p < 0.05). CONCLUSIONS: Improper packaging and storage conditions may reduce the quality of amoxicillin-clavulanic acid preparations at community pharmacies. Strict quality control measures are urgently needed to maintain the quality of amoxicillin-clavulanic acid in tropical countries.

Simple and rapid UV spectrophotometry of caffeine in tea coupled with sample pre-treatment using a cartridge column filled with polyvinylpolypyrrolidone (PVPP).

We have applied a sample pre-treatment method with a cartridge column filled with polyvinylpolypyrrolidone (PVPP) to the effective removal of polyphenols and simple UV spectrophotometry of caffeine in tea. The absorption maximum length (lambda(max)) for caffeine was close to those for tea catechins in aqueous 1% acetic acid; therefore, the UV spectrum of a non-treated green tea sample had a large absorption wave. In contrast, the absorbance of the green tea sample was gradually reduced by PVPP cartridge treatment using PVPP from 0 to 50 mg, and was nearly constant using a pre-treatment cartridge with more than 100 mg PVPP, because tea catechins were effectively removed and caffeine was mostly recovered from a green tea sample by means of PVPP cartridge treatment. The PVPP pre-treatment cartridge also removed polyphenols successfully from oolong and black tea samples. Comparison with conventional HPLC analysis indicated that the present pre-treatment method with a PVPP cartridge was useful for the simple and selective UV spectrophotometric determination of caffeine in green, oolong and black tea samples.

Quasi-flow injection analysis for rapid determination of caffeine in tea using the sample pre-treatment method with a cartridge column filled with polyvinylpolypyrrolidone.

The sample pre-treatment method using a polyvinylpolypyrrolidone (PVPP) cartridge column combined with a quasi-flow injection analysis (quasi-FIA) system realized the rapid determination of caffeine in three types of tea, green, oolong and black tea. The measurement time for each tea sample pre-treated using a PVPP cartridge column was shortened to 20s. In the present system, the limits of detection and quantification were 0.3 microM (1.5 pmol injected) and 0.7 microM (3.5 pmol injected), respectively, and a linear calibration curve was afforded up to 800 microM (4 nmol injected). Within-run precision of analysis of standard solutions of 10 and 100 microM caffeine was 0.11 and 0.16% (n=6), respectively. Between-run precision of analysis of the same solutions over 6 days was 0.78 and 0.74% (n=6), respectively. Comparison with the conventional HPLC method indicated that the present quasi-FIA method using sample pre-treatment with a PVPP cartridge column was useful for the simple and precise determination of caffeine in green, oolong and black tea samples.

Improved sample pre-treatment for determination of caffeine in tea using a cartridge filled with polyvinylpolypyrroridone (PVPP).

We have improved sample pre-treatment for the effective removal of polyphenols and simple analysis of caffeine in tea using a cartridge filled with polyvinylpolypyrroridone (PVPP). Nearly 100% of catechins were removed from the green tea sample and caffeine was completely recovered in the range of 98.2-101.3% by sample pre-treatment with a PVPP cartridge. Reproducibility of preparing PVPP pre-treatment cartridges was sufficient for quantitative analysis, because RSDs of analytical values for caffeine obtained by using three individual pre-treatment cartridges filled with 10-200 mg PVPP were 0.60-2.8%. The PVPP pre-treatment cartridge also removed polyphenols perfectly and recovered caffeine faultlessly from oolong and black tea samples. Comparison with the conventional method without sample pre-treatment indicated that the present pre-treatment method with a PVPP cartridge was useful for the simple and precise analysis of caffeine in green, oolong and black tea samples.