Informatics Publishing Limited

H Ramakrishna Reddy ¹, S. R. Pratap ², N. Chandrasekhar ¹, S. Z. Mohamed Shamshuddin

Affiliations
1 Research and Development Centre, Bharathiar University, Coimbatore - 641046, Tamilnadu,, IN
2 Chemistry Research Laboratory, HMSIT, Tumkur, Karnataka, IN

Abstract

The objective of present study was to analyze Diethylhexyl phthalate content in 5% Dextrose injection and other reconstituting diluents for pharmaceutical injectable formulations. Reconstituting diluents for pharmaceutical injectable formulations are mainly stored and supplied in polyvinyl chloride bags. This may lead to leaching of Diethylhexyl phthalate, a toxic content from polyvinyl chloride bags into reconstituting formulations. In the current study, a proficient and simple method by using a Gas Chromatograph was developed and validated for the quantitation of trace amounts of Diethylhexyl phthalate in 5% Dextrose injection. The method was optimized by using silica fused short capillary column (DB-1; USP G2 phase) with dimensions 5 m length x 0.53 mm inner diameter and 2.65μm film thickness. The method involves a simple extraction procedure for sample preparation by means of extraction with n-Hexane solvent and evaporation with a stream of nitrogen gas. An Internal standard (1-Phenydodecane) was added to standard and sample preparations by using n-Hexane as diluent. The method was validated as per the current regulatory guidance for analytical method validation.The projected methodology was found to be selective, accurate, precise, and linear in the test concentration range from 0.004 μg/mL to 5.065μg/mL for Diethylhexyl phthalate. The method was effectively used to analyze the Diethylhexyl phthalate content in 5% Dextrose Injection and other reconstituting diluents for pharmaceutical injectable formulations.

Keywords

Diethylhexyl phthalate, 1-Phenyldodecane, Gas chromatography, 5% Dextrose injection, Reconstituting diluents.

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