Abstract
PurposeThe purpose of this study is to establish Loratadine [LRD] quantification in purified and capsule formulations using a precise and specific Reversal Phase with a very high-performance liquid Chromatographic [RP-HPLC] technique. The approach was evaluated in agreement with the principles of the International Conference on Harmonization [ICH]. Arcus EP-C18 Ion Pac column, 5 m, 4.6 mm, 250 mm, mobile phase Methanol: Acetonitrile (60:40) v/v. Dibasic potassium phosphate buffer, pH 7.2, flow rate 1.0 ml/min.Design/methodology/approachThe HPLC system used a 340 nm UV detector for testing. A 10-min run time was used for the analysis. At concentrations ranging from 2 to 10 g/ml, the technique was linear (R2 = 0.9998), exact (intra-day and inter-day relative standard deviation [RSD] values 1.0%), accurate (range recovery = 96%–102%), exclusive and strong.FindingsThe detecting and quantitation limits were 0.92 g/ml and 2.15 g/ml, respectively.Originality/valueThe findings demonstrated that the proposed method could accurately determine LRD in bulk and pill dose formats quickly and accurately.
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