Development and validation of a reversed‐phase HPLC method for determination of nitrendipine in rat plasma: application to pharmacokinetic studies

Abstract

A simple and sensitive method for the determination of nitrendipine in rat plasma was developed using high-performance liquid chromatography (HPLC). The procedure involves extraction of nitrendipine in dichloromethane/sodium hydroxide, followed by reversed phase HPLC using a Waters, Spherisorb ODS2 (250 x 4.6 mm, 5 microm) column and UV detection at 238 nm. The retention times of nitrendipine and internal standard (felodipine) were 5.0 min and 7.5 min, respectively. The calibration curves were linear over the range of 5 ng/mL (lower limit of quantification, LOQ) to 200 ng/mL for nitrendipine. The intra- and inter-day coefficients of variation for all criteria of validation were less than 15% over the linearity range. The sensitivity and precision of the method were within the accepted limits (< 15%) throughout the validation period. The present method was also successfully applied for the study of plasma pharmacokinetics of nitrendipine loaded solid lipid nanoparticles (SLN) in rats.

Simultaneous determination of nitrendipine and hydrochlorothiazide in spontaneously hypertensive rat plasma using HPLC with on-line solid-phase extraction

“…HPLC methods with DAD [11,12], electrochemical [13][14][15] or LC-MS detection [16][17][18] have been developed for determination of either NTDP or HCTZ separately. Simultaneous determination of two compounds in the tablets by HPLC-DAD has been published [19], but the qualification limit of which was too high to meet the requirements of the biological fluids analysis.…”

Preparation of starch macrocellular foam for increasing the dissolution rate of poorly water-soluble drugs

“…After shaking for 5 min, the samples were centrifuged at 12 750g for 10 min. Then, 20 mL samples of supernatant were subjected to HPLC analysis 33,34 .…”

Development of a liquid chromatography/negative-ion electrospray tandem mass spectrometry assay for the determination of cilnidipine in human plasma and its application to a bioequivalence study

“…Previous publications have described HPLC-UV [12,13], LC-MS [14] and LC-MS/MS [15,16] method for the analysis of dihydropyridine drugs in biological samples. However, these methods are not suitable for pharmacokinetics work, because they involve arduous sample preparation and long chromatographic run-times.…”