Abstract

Author(s): Abeer Ayidh Alghamdi, Aljawharah Mohammed Alanazi, Fawziah Harb Hommady, Norah Aldeghaither, Sultan Alqahtani , Ibrahim K. Farh And Mahmoud Mansour*
Department of Basic Pharmaceutical Sciences, College of Pharmacy, King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Ministry of the National Guard-Health Affairs, 1Department of Basic Medical Sciences, College of Medicine, King Saud bin Abdulaziz University for Health Sciences, Riyadh 11481, Saudi Arabia

Correspondence Address:
Mahmoud Mansour, Department of Basic Pharmaceutical Sciences, College of Pharmacy, King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Ministry of the National Guard-Health Affairs, Riyadh 11481, Saudi Arabia, E-mail: mansoura@ksau-hs.edu.sa

Several techniques, such as high-performance liquid chromatography and ultraviolet-visible spectroscopy, have been developed and validated for analyzing allopurinol in various pharmaceutical formulations. In this study, the validated method was applied to analyze two allopurinol products available in the market (No-Uric, and Loric). The chromatographic separation involved a mobile phase consisting of a 50:50 ratio of acetonitrile to buffer 4.6 v/v. The separation process utilized a C18 rapid resolution column (4.6×100 mm, 3.5 μm, agilent high-performance liquid chromatography column). The λ_max of allopurinol was found to be at 254 nm. Separation was achieved using a 20 μl injection volume with a run time of 3.0 min. The method exhibited linearity within a concentration range of 2.5-15 μg/ ml for allopurinol. Method validation was performed in accordance with International Council for Harmonization guidelines, including evaluations of specificity, selectivity, linearity, accuracy, precision, lower limit of quantification and lower limit of detection. The established lower limit of quantification and lower limit of detection for allopurinol were 4.09 μg /ml and 1.36 μg /ml, respectively. The percentage assay for all pharmaceutical products containing allopurinol met the acceptance criteria range of 90 %-110 %. These methodologies proved effective for the accurate quantitative analysis of allopurinol in pharmaceutical formulations.

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