Quantitative spectrofluorimetric method for determination of octreotide acetate synthetic peptide derivative in pure and its Sandostatin ampules forms.

Abstract

A unique spectrofluorimetric protocol has been conceived for octreotide (a synthetic peptide drug) quantitation in both its authentic form and its application to dosage form. The protocol has been established simply upon condensation of octreotide by ninhydrin / phenyl acetaldehyde reagent in buffered media (pH 6.2). An intense fluorescence product has been formed and quantified at 463 nm (390 nm for excitation). After optimization for various experimental conditions, a wide linear interval (0.2-4.0 µg/ml) has been used to construct the calibration curve with a determination coefficient (r²) of 0.9994, a slope ± SD of 81.147 ± 0.7985, and a highly sensitive detection and quantitation limits nearly equal to 0.066 and 0.2 µg/ml, respectively. A proposed protocol has been checked in accordance with ICH validation guidelines, which indicate good accuracy and high precision of the proposed method. Furthermore, this protocol could be perfectly applied for the quantitative estimation of octreotide in its ampoules with a high degree of accuracy and precision. As a result, a developed protocol is ideally appropriate for fast and simple octreotide quantitative estimation in quality control laboratories.