Development and validation of high performance liquid chromatographic and derivative spectrophotometric methods for determination of gadodiamide in liposomal formulations

Abstract

High performance liquid chromatography and derivative spectrophotometry were applied for determination of gadodiamide in liposomes.

Chemometric-Assisted Hydrophilic Interaction Chromatographic Method for the Determination of Gadolinium-Based Magnetic Resonance Imaging Contrast Agent in Liposomes

“…20,[25][26][27][28][29] Despite the indisputable detectability provided by MS, the high cost of analysis and instrumentation justifies the development of simpler and less costly method. In a previous study by our research group, 2 an analytical method for the determination of Gd-DTPA-BMA by RP-LC/DAD was developed and validated. It showed to be linear in the range between 100 and 500 nmol mL -1 .…”

“…Despite this, its administration is contraindicated in patients presenting chronic renal failure due to the risk of developing nephrogenic systemic fibrosis. [1][2][3] Recently, the European Medicines Agency (EMA) 4 confirmed a review that found that Gd deposition can occur in brain tissues after the use of Gd contrast agents. Until the present date, there is no evidence that Gd deposition in the brain has caused any harm to patients.…”

“…In addition, this additional step makes the analysis more time consuming. 2 The determination of Gd-DTPA-BMA by LC using radioactivity detectors has also been described. 17,19 In this case, the main disadvantage is related to the requirement of prior radiolabeling of the complex.…”

“…In both methods, detection was performed in the ultraviolet region. 2 The spectrophotometric method presented low detectability, while retention of Gd-DTPA-BMA in RP-LC was challenging due to its high polarity. Moreover, RP-LC method is not appropriate for determination of this drug in more complex matrices, such as serum, plasma, culture medium or buffers fortified with blood proteins.…”

Development and validation of analytical method by HPLC-DAD for determination of vasodilator active in pharmaceutical ophthalmic forms

“…Atsriku et al (2002) and Campbell et al (2004) described the determination and identification of DIZE and its degradation products by liquid chromatography coupled with mass spectrometry (LC-MS). However, these methods are not suitable for 4-AD quantification, require complex instrumentation, and are more expensive than high performance liquid chromatography (HPLC) (Maia et al, 2015). Hence, the development of an analytical method is necessary to detect and identify 4-AD in pharmaceutical forms.…”