Micellar electrokinetic chromatographic determination of rosuvastatin in rabbit plasma and evaluation of its pharmacokinetics and interaction with niacin

Abstract

A specific, accurate, precise and reproducible micellar electrokinetic chromatographic method was developed for in vitro and in vivo estimation of rosuvastatin, a synthetic and potent HMG-CoA inhibitor, in rabbit plasma. Further, its pharmacokinetics in the presence of niacin, which could be co-administered for monitoring of severe hypercholestremia, was investigated. The assay procedures involved simple liquid-liquid extraction of rosuvastatin and internal standard, atorvastatin, from a small plasma volume directly into acetonitrile. The organic layer was separated and evaporated under a gentle stream of nitrogen. The residue was reconstituted in the mobile phase and injected electrokinetically into electropherosis system. The background electrolyte consisted of borate buffer (25.0 mm, pH 9.5), 10.0% organic modifier (5.0% methanol + 5.0% acetonitrile) and 25.0 mm sodium dodecyl sulfate at 20.0 kV applied voltage and 215.0 nm detection wavelength for the effective separation of rosuvastatin, niacin and atorvastatin.

Analytical Methods for the Determination of Rosuvastatin in Pharmaceutical Formulations and Biological Fluids: A Critical Review

“…Other techniques for ROS quantification were also applied, including capillary zone electrophoresis, mercury drop electrode, highly sensitive enzyme-linked immunosorbent assay (ELISA), high-performance thin-layer chromatography (HPTLC), and TLC, as demonstrated in Table 5. [54,[130][131][132][133][134][135][136][137][138] A microwell-based automated spectrophotometric method for determination of drugs using a colored charge-transfer (CT) complex has been developed as an alternative for the conventional spectrophotometric technique. [137][138][139][140] This non-conventional spectrophotometric assay demonstrated advantages, such as automation, lower consumption of organic solvents, and relative sensitivity with the limit of quantification of 7.85 mg/well for the quantification of ROS.…”

Validated Selective HPLC-DAD Method for the Simultaneous Determination of Diclofenac Sodium and Lidocaine Hydrochloride in Presence of Four of Their Related Substances and Potential Impurities

“…Also, the gradient program involves a single step of linear change of the mobile phase composition without variations in flow rate or wavelength. The described method is much more selective and superior over all previously reported analytical methods for DC-LD mixture [41][42][43]. A significant advantage in the study is the separation of both analytes from four of their related substances and potential impurities.…”

“…Nevertheless, a more comprehensive stability-indicating method is still required to ensure the assay of both drugs in presence of all their forced degradation products, and this can be the target for a future work. The diode array detector used in this study is superior compared to the universal UV detector used in the previously published HPLC methods [41,42] since the DAD has the advantage of being a tool for peak identity and purity confirmation; however, the developed method can be adapted to conventional HPLC with UV detection which is the most popular in quality control laboratories. Regarding sensitivity, the developed method is comparable or even advantageous over several previous methods of analysis for the cited drugs [4, 25, 26, 32, 34, 35, 38-40, 42, 43].…”

“…Assay results revealed satisfactory accuracy and precision as indicated from % recovery, SD, and RSD % values (Table VI). Furthermore, a reference reversed-phase HPLC method [42] was applied for the simultaneous determination of DC and LD in their combined formulation. Recovery data obtained from the developed HPLC-DAD method were statistically compared with those of the reference method using the Student's t-tests and the variance ratio F-tests.…”

“…The simultaneous determination of the binary combination of DC and LD has been addressed in very few analytical reports. These reports proposed several reversed-phase HPLC methods [41,42] and a micellar electrokinetic chromatographic (MEKC) method [43]. Reviewing the literature exposed that there were no reports for the simultaneous selective determination of DC and LD in presence of their related substances and potential impurities.…”