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- Title
Chromatographic determination of allopurinol and lesinurad simultaneously in raw and tablet forms.
- Authors
Sravanthi, T.; Madhavi, N.
- Abstract
Objective: A novel stability-indicating high-pressure liquid chromatography procedure was developed followed by validation for the simultaneous estimation of allopurinol and lesinurad in bulk and was applied on the marketed formulations of allopurinol and lesinurad. Materials and Methods: The mobile phase used for the chromatographic runs consisted of methanol: acetonitrile:0.05 M phosphate buffer, pH 6.2 (25:60:15 v/v/v). The separation was achieved on a ProntoSIL Hypersorb ODS C18 column (4.6 mm x250 mm; 5 µ) using isocratic mode. Allopurinol and lesinurad peaks are well separated and detected at 239 nm using ultraviolet detector. Results: The method was linear in the quantity range of 75-600 µg/ml for allopurinol and 50-400 µg/ml for lesinurad. The method was verified in full compliance with ICH directives. Allopurinol's detection limit (DL) and quantification limit (QL) were 0.032 µg/ml and 0.097 µg/ml, respectively, while DL and QL for lesinurad were 0.022 µg/ml and 0.067 µg/ml, respectively. The validation study results showed that developed procedure was selective (no obstruction from diluent and excipients of tablet), specific (no obstruction from degradants formed during stability testing), precise (relative standard deviation [RSD] value - <2.0%), rugged (RSD value - <2.0%), accurate (recovery percent near to 100%), and robust (difference value - <2.0%). Conclusion: The reported method can also be used effectively in marketed formulations for routine analysis of allopurinol and lesinurad.
- Subjects
ULTRAVIOLET detectors; HYDROCHLOROTHIAZIDE; LIQUID chromatography; DETECTION limit; STANDARD deviations; ALLOPURINOL; ULTRAVIOLET spectrophotometry; MICELLAR liquid chromatography
- Publication
Drug Invention Today, 2020, Vol 13, Issue 6, p959
- ISSN
0975-7619
- Publication type
Article