Assessment of the quality of levonorgestrel emergency contraceptive tablets (morning-after pill) sold in Uganda

Abstract

Use of poor quality emergency contraceptives may lead to unwanted pregnancies. Many unwanted pregnancies lead to illegal abortions having a devastating impact on the health of the girl child and women at large. This study was aimed at assessing the quality of levonorgestrel tablets sold on the Ugandan market. The quality of levonorgestrel tablets was established through collection of samples from the Eastern, Western, Central and Northern regions of Uganda. The High Performance Thin Layer Chromatography (HPTLC) and the High Performance Liquid Chromatography (HPLC) analytical techniques were used to identify and determine the content of levonorgestrel, respectively. The quality parameters assessed included visual inspection, identification, content uniformity, assay and dissolution. Results showed that thirteen percent of samples found on the market were counterfeits and all belonged to brand G. The samples that had been confirmed counterfeits further failed the uniformity of content, assay and dissolution tests. Eighty-seven percent of the samples found on the market passed the assay and uniformity of content test and the statistical analysis conducted at 95% CI revealed significant differences (ANOVA, p < 0.05) within the brands in the mean uniformity of content and assay results. Further findings showed that 30% of the samples on market exhibited inadequate release of levonorgestrel by dissolution testing whereas 13% showed no release of levonorgestrel. Similarly, the statistical analysis conducted using the one-way ANOVA at 95% CI revealed that there was a significant difference (p < 0.05) in the drug release of the different brands of levonorgestrel tablets examined in the study. From the study it was observed that only 57% provided the stated level of contraceptive action, 30% provided questionable results whereas 13% offered no prevention against unwanted pregnancy. The statistically significant differences observed further indicated the availability of levonorgestrel tablets on the market that are not therapeutically equivalent. It was concluded that there is need to emphasize regular assessment of the quality of emergency contraceptives on the market in order to lower the risk of patients being exposed to products of poor quality, safety, and efficacy.