DEVELOPMENT AND VALIDATION OF A REVERSED-PHASE HPLC METHOD FOR ASSAY OF THE OCTAPEPTIDE OCTREOTIDE IN RAW MATERIAL AND PHARMACEUTICAL DOSAGE FORM

Abstract

The objective of this study was to develop and validate reverse phase high-performance liquid chromatography (RP-HPLC) method for the quantification of octreotide, a somatostatin analogue, in raw material and injectable dosage form by using a UV detector. Octreotide drug molecules are used for carcinoid tumor and acromegaly. RP-HPLC quantification was carried out by using mobile phase comprising acetonitrile, water and tetrabutylammonium hydroxide through an octadecylsilyl (C18) end-capped column (250 mm × 4.6 mm, 5 µm). The flow rate for this assay was 1 ml/min and detection was performed at 210 nm. This method was validated according to the guidelines of the International Council for Harmonization (ICH). The assay was linear in concentration range 0.2-1.8 µg/ml with relative standard deviation less than 2. The performed assay was sensitive with a limit of detection (LOD) 0.025 µg/mL and a limit of quantification (LOQ) 0.084 µg/ml. Similarly, the percentage recovery was 97.02-99.25% that showed the accuracy of the developed method. Results of this study confirmed that method was sensitive, specific, accurate and precise for quantification of octreotide in raw material and injectable dosage forms by using common UV detector.