Introduction: Prevention and optimal management of hypertension in the general population is paramount to the achievement of the WHF goal of reducing cardiovascular disease mortality by 25% by the year 2025. Widespread access to good quality antihypertensive medicines is a critical component for achieving the goal. Poor quality medicines including those that are of substandard quality pose serious health concerns however, there remains a knowledge gap about the quality of generic antihypertensive medicines especially in lowmiddle income countries. Objectives: To determine the quality of generic antihypertensive medicines available in the retail market of a developing country. Methods: We purchased samples of the two most commonly prescribed classes of antihypertensive medicines from three states in three different geopolitical zones in Nigeria following a semi-random sampling framework. Samples were purchased by a mystery shopper from each of 24 pharmacy outlets from six local government areas (1 rural and 1 urban per state) across each of the three states. Samples were analyzed for content at the London School of Hygiene and Tropical Medicine, bioanalytical facility. The stated active pharmaceutical ingredient (SAPI) in each sample was measured using high-performance liquid chromatography photodiode array detection with results expressed as percentage of SAPI. Samples were classified as good quality (acceptable pharmaceutical quality, if compliant with pharmacopeia tolerance limits of 90-110% SAPI), poor quality (substandard, if contains either less or more than the acceptable dose, <90->110% SAPI) and falsified (no SAPI). Results: Amlodipine and Lisinopril were identified as the most commonly prescribed antihypertensive drugs in Nigeria. In total, 440 samples from 24 pharmacies were collected and tested. We found 69.4% of Amlodipine and 69.9% of Lisinopril samples were of acceptable pharmaceutical quality. However, 30.6% of Amlodipine and 33.1% of Lisinopril samples were of substandard quality. We did not detect any falsified samples of either Amlodipine or Lisinopril. Conclusion: About one-third of commonly prescribed anti-hypertensive drugs available in Nigeria appear to be of substandard quality. Enhanced quality assurance processes in lowmiddle income countries such as Nigeria are needed to support optimum management.
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