Isocratic ultra-performance liquid chromatographic assay of quetiapine fumarate in pharmaceuticals

N RAJENDRA PRASAD, Prof Kanakapura Basavaiah

Abstract


An isocratic and reversed phase ultra-performance liquid chromatographic (RP-UPLC) method has been developed for the determination of quetiapine fumarate (QTF)) in bulk drug and in its tablets.  The method was developed using AQUITY UPLC HSS T3 (2.1 x 50 mm, 1.8µm) column with mobile phase consisting of 30:70 (v/v) mixture of potassium dihydrogen phosphate and dipotassium hydrogen phosphate (pH was adjusted to 6.5 with orthophosphoric acid) (mobile phase A) and methanol (mobile phase B). The UV detection of the eluted compound was made at 252 nm. The flow rate of the mobile phase was adjusted at 1.0 ml min-1. The injection volume of operation was set at 5.0 µL. A linear calibration curve was obtained for the concentration range 1.0 – 15.0 µg mL-1 QTF with regression coefficient (r) value of 0.9999. The limit of detection (LOD) and quantification (LOQ) were found 0.04 and 0.1µg ml-1, respectively, and which is at signal to noise ratio of 3 and 10. Three quality control concentrations of 7.5, 10 and 12.5 µg ml-1 QTF were subjected to study of accuracy and precision of the assay and the results were satisfactory. Both within day and between days RSD were less than 3%. The validation of the developed method was done in accordance with the ICH guidelines. The method was successfully applied to the determination of QTF in pharmaceuticals and no interference was observed from common pharmaceutical adjuvants in tablets. Statistical comparison of the results with those of an official method showed an excellent agreement and indicated no significant difference in precision

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