Análisis de calidad de captopril en tabletas de 25 mg comercializadas en el mercado peruano
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Date
2022
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Universidad Nacional de Trujillo
Abstract
Este informe de prácticas preprofesionales se efectuó con el objetivo de evaluar la calidad de captopril en tabletas de 25mg comercializadas en el mercado peruano. Se trabajó con cuatro productos multifuente, siendo uno de marca. El procedimiento para cada ensayo se realizó en base a lo descrito en la monografía individual de tabletas de captopril de la USP 42. En la identificación se obtuvo un tiempo de retención de 5,2 min para el estándar y los productos multifuente. En la valoración se obtuvieron porcentajes de contenido promedio entre 95 y 99%. En el ensayo de disolución se obtuvieron porcentajes de disolución promedio mayores a 99% para todos los productos multifuente. En la variación de peso se obtuvieron valores de aceptación bajos (L1<6) en todos los productos. El análisis de impurezas por IR no mostró diferencias notorias entre los productos y el estándar, caso contrario al análisis por DSC y LC-MS/MS donde se logró identificar trazas de captopril disulfuro, presentándose una mayor y menor proporción en el producto multifuente A y D respectivamente. Concluyendo que las tabletas de captopril 25mg comercializadas en el mercado peruano cumplen con los ensayos de calidad descritos en la USP 42.
ABSTRACT This report of pre-professional practices was carried out with the objective of evaluating the quality of captopril in 25mg tablets marketed in the Peruvian market. We worked with four multi-source products, one of which was branded. The procedure for each test was carried out based on that described in the individual monograph of captopril tablets of USP 42. In the identification, a retention time of 5.2 min was obtained for the standard and multi-source products. In the assessment, average content percentages between 95 and 99% were obtained. In the dissolution test, average dissolution percentages greater than 99% were obtained for all multi-source products. In the weight variation, low acceptance values (L1<6) were obtained in all products. The analysis of impurities by IR did not show noticeable differences between the products and the standard, contrary to the analysis by DSC and LC-MS/MS where it was possible to identify traces of captopril disulfide, presenting a greater and lower proportion in the multisource product A and D respectively. Concluding that captopril 25mg tablets marketed in the Peruvian market meet the quality tests described in USP 42.
ABSTRACT This report of pre-professional practices was carried out with the objective of evaluating the quality of captopril in 25mg tablets marketed in the Peruvian market. We worked with four multi-source products, one of which was branded. The procedure for each test was carried out based on that described in the individual monograph of captopril tablets of USP 42. In the identification, a retention time of 5.2 min was obtained for the standard and multi-source products. In the assessment, average content percentages between 95 and 99% were obtained. In the dissolution test, average dissolution percentages greater than 99% were obtained for all multi-source products. In the weight variation, low acceptance values (L1<6) were obtained in all products. The analysis of impurities by IR did not show noticeable differences between the products and the standard, contrary to the analysis by DSC and LC-MS/MS where it was possible to identify traces of captopril disulfide, presenting a greater and lower proportion in the multisource product A and D respectively. Concluding that captopril 25mg tablets marketed in the Peruvian market meet the quality tests described in USP 42.
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Keywords
Captopril, Calidad, Farmacopea, HPLC.