Abstract
This study describes the development and evaluation of stability-indicating liquid chromatographic (LC) and UV spectrophotometric methods for the quantification of ciprofibrate (CPF) in tablets and capsules. Isocratic LC separation was achieved on a RP18 column using a mobile phase of o-phosphoric acid (0.1% v/v), adjusted to pH 3.0 with triethylamine (10% v/v) and acetonitrile (35:65 v/v), with a flow rate of 1.0 mL min-1. Detection was achieved with a photodiode array detector at 233 nm. For the spectrophotometric analysis, ethanol and water were used as the solvent and a wavelength of 233 nm was selected for the detection. The methods were validated according to International Conference on Harmonization (ICH) guidelines for validating analytical procedures. Statistical analysis showed no significant difference between the results obtained by the two methods. The proposed methods were successfully applied to the CPF quality-control analysis of tablets and capsules.
Highlights
Ciprofibrate (CPF, Figure 1) is a hypolipidemic drug that is widely used to treat hypertriglyceridemia.Its chemical name is 2-(4-(2,2-dichlorocyclopropyl) phenoxy)-2-methylpropanoic acid and its mechanism of action is based on the activation of specific transcription factors called peroxisome proliferator-activated receptors (PPARs), which alter the transcription of several genes that encode the proteins that control lipoprotein metabolism (Bighetti et al, 2009; Bermúdez-Pirela et al, 2005; European Pharmacopeia, 2008).F
Acetonitrile and methanol are commonly used solvents in reverse-phase LC, because they have low UV cut-off points of 190 and 205 nm, respectively. These solvents are miscible with aqueous solutions, so reversephase chromatography was performed with various mixtures of organic and aqueous solvents
Acetonitrile and methanol were used in the mobile phase at different ratios, which resulted in an asymmetric peak with a large tailing factor (T >2) and a very low retention time (Figure 2f)
Summary
Ciprofibrate (CPF, Figure 1) is a hypolipidemic drug that is widely used to treat hypertriglyceridemia. Its chemical name is 2-(4-(2,2-dichlorocyclopropyl) phenoxy)-2-methylpropanoic acid and its mechanism of action is based on the activation of specific transcription factors called peroxisome proliferator-activated receptors (PPARs), which alter the transcription of several genes that encode the proteins that control lipoprotein metabolism (Bighetti et al, 2009; Bermúdez-Pirela et al, 2005; European Pharmacopeia, 2008).
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