Gradient HPLC analysis of raloxifene hydrochloride and its application to drug quality control
| Autor: | Kalsang Tharpa, Urdigere Rangachar Anil Kumar, Kanakapura Basavaiah |
|---|---|
| Rok vydání: | 2008 |
| Předmět: |
Quality Control
Selective Estrogen Receptor Modulators Pharmacology Detection limit Hplc analysis Accuracy and precision Chromatography medicine.diagnostic_test Chemistry Raloxifene Hydrochloride Analytical chemistry Reproducibility of Results Pharmaceutical Science General Medicine High-performance liquid chromatography Drug quality Standard curve Spectrophotometry medicine Technology Pharmaceutical Spectrophotometry Ultraviolet Chromatography High Pressure Liquid Tablets |
| Zdroj: | Acta Pharmaceutica. 58 |
| ISSN: | 1846-9558 1330-0075 |
| DOI: | 10.2478/v10007-008-0018-z |
| Popis: | A rapid, sensitive and selective method for the determination of raloxifene hydrochloride (RLX) in pure drug and in tablets was developed using gradient high performance liquid chromatography (HPLC). The devised method involved separation of RLX on a reversed phase Hypersil ODS column and determination with UV detection at 284 nm. The standard curve was linear (R = 0.999) over the concentration range of 50-600 microg mL-1 with a detection limit of 0.04 microg mL-1 and a quantification limit of 0.16 microg mL-1. Intra-day and inter-day precision and accuracy of the method were established according to the current ICH guidelines. Intra-day RSD values at three QC levels (250, 450 and 550 microg mL-1) were 0.2-0.5%, based on the peak area. The intra-day relative error (er) was between 0.2 and 0.5%. The developed method was successfully applied to the determination of RLX in tablets and the results were statistically compared with those obtained by a literature method. Accuracy, evaluated by means of the spike recovery method, was the excellent with percent recovery in the range 97.7-103.2 with precision in the range 1.6-2.2%. No interference was observed from the co-formulated substances. The method was economical in terms of the time taken and the amount of solvent used. |
| Databáze: | OpenAIRE |
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