Determination of human growth hormone in pure and pharmaceutical dosage form by spectrofluorometry and high performance liquid chromatography

Abstract

In this study, a new and rapid spectrofluorometry and high performance liquid chromatography (HPLC) methods were developed for determination of human growth hormone in pure and pharmaceutical dosage form. The solvent system, wavelength of detection and chromatographic conditions were optimized in order to maximize the sensitivity of both the proposed methods. The linearity was established over the concentration range of 1.25-50μg mL-1 for spectrofluorometry and 10-75μg mL-1 for HPLC method. The intra- and inter-day relative standard deviation (RSD) was less than 8.46 and 5.98% for spectrofluorometry and HPLC, respectively. Limits of quantitation were determined as 0.075 and 7.5μg mL-1 for spectrofluorometry and HPLC, respectively. No interference was found from tablet excipients at the selected assay conditions. The methods were applied for the quality control of commercial growth hormone dosage form to quantify the drug and to check the formulation content uniformity.

Keywords

• growth hormone
• spectrofluorometry
• HPLC
• validation