Determination Of Nitrendipine Research Articles

Optimization and validation of a MEKC method assisted by Box–Behnken Design for fast and simultaneous determination of nitrendipine and atenolol in new antihypertensive combination tablets

In this paper, we established a micellar electrokinetic chromatography method for fast and simultaneous determination of nitrendipine and atenolol in new antihypertensive combination tablets. Buffer conditions were optimized by using a multivariate response surface methodology (RSM) established by Box–Behnken Design in terms of sodium dodecyl sulfate concentration, buffer concentration and pH of buffer. Under the optimum buffer conditions, the separation of the two drugs can be finished in 3 minutes in a 31.2 cm × 50 μm fused-silica capillary at an applied voltage of 25 kV and the temperature of 25 °C. The optimal running buffer (pH 8.9) was Na2B4O7 (7.5 mmol L−1) and NaH2PO4 (30 mmol L−1) containing 15 mmol L−1 sodium dodecyl sulfate. Good correlation coefficients were found (γ2 >0.999) at concentrations of 5–17.5 μg mL−1 for nitrendipine and 10–35 μg mL−1 for atenolol, respectively. All the RSD results of precision experiments were below 3%. The recoveries of nitrendipine and atenolol were 98.98–100.15% and 99.46–101.18%, respectively. The limits of detection of this method were 1 μg mL−1 and 0.5 μg mL−1 for nitrendipine and atenolol and the limits of quantification of this method were 2.5 μg mL−1 for nitrendipine and 1.5 μg mL−1 for atenolol. After the optimization, the method was successfully applied for the content uniformity test according to the United States Pharmacopeia.

Ultra-performance liquid chromatography-tandem mass spectrometry method for the determination of nitrendipine in dog plasma and its application to a pharmacokinetic study of a solid self-emulsifying pellet formulation

A rapid, sensitive and selective ultra-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) method was developed and validated for the quantitative determination of nitrendipine (NTD, CAS 39562-70-4) in dog plasma. Using propranolol hydrochloride (CAS 318-98-9) as an internal standard (IS), plasma samples pretreatment adopted a simple liquid-liquid extraction process with diethyl ether. Separation was carried out by a gradient elution on an Acquity UPLC BEH C18 column with a mobile phase consisting of water (containing 0.1% formic acid) and acetonitrile. Detection was performed by a triple-quadrupole mass spectrometry with positive electrospray ionization (ESI) as source ionization in multiple-reaction monitoring (MRM) mode at m/z 361.0 --> 315.0 for NTD and m/z 260.2 --> 116.0 for IS. The method demonstrated good linearity at the concentrations ranged from 0.1-200 ng/mL and the lower limit of quantification (LLOQ) of NTD was 0.1 ng/mL. The intra- and inter-day relative standard deviations (RSD) were less than 10%. The mean extraction recoveries of NTD and IS were 90.2% and 82.4%, respectively. Finally, the method was successfully applied to a pharmacokinetic study of home-made solid self-emulsifying pellets and conventional NTD tablets in beagle dogs following a single oral administration.

On-Line Solid-Phase Extraction Based on Poly (Nipaam-MAA-co-EDMA) Monolith Coupled with High-Performance Liquid Chromatography for Determination of Nitrendipine and Nisoldipine in Human Urine

A solid-phase extraction absorbent material based on poly (N-isopropylacrylamide-co- methacrylic acidco-ethylene glycol dimethacrylate) [poly (NIPAAm-MAA-co-EDMA)] monolithic column was developed for the simultaneous determination of nitrendipine and nisoldipine from human urine. The morphology of monolithic column and pressure drop across the columns were characterized. The results showed excellent permeability and high selectivity. Urine samples (0.05 mL) were injected directly onto the prepared Solid-Phase Extraction (SPE) monolithic column. Most biological matrix compounds in urine were removed by on-line SPE technology, while nitrendipine and nisoldipine retained on the SPE column were effectively separated on a C18 analytical column. For all analytes, linear calibration curves were obtained over a range of 50-500 ng/mL with coefficient of correlation > 0.9996. Accuracy and precision for inter- and intra-day assay showed acceptable results for quantitative assay with Relative Standard Deviation (RSD) less than 10%. The recovery was found to be in the range of 89-102%. The results indicated that the prepared monolith was feasible to be use as an on-line SPE sorbent material and the method was especially appropriate for multi-analytes monitoring in urine samples.

Stability-indicating methods for the enantioselective determination of dihydropyridines by high performance liquid chromatography and capillary electrophoresis

This paper presents simple, rapid, precise and accurate stability-indicating HPLC and CE methods, which were developed and validated for the determination of nitrendipine, nimodipine and nisoldipine. These drugs are calcium channel antagonists of the 1,4-dihydropyridine type which are used in the treatment of cardiovascular diseases. Experimental results showed a good linear correlation between the area and the concentration of drugs covering a relatively large domain of concentration in all cases. The linearity of the analytical procedures was in the range of 2.0–120.0 μg mL−1 for nitrendipine, 1.0–100.0 μg mL−1 for nimodipine and 100.0–600.0 μg mL−1 for nisoldipine, the regression determination coefficient being higher than 0.99 in all cases. The proposed methods were found to have good precision and accuracy. The chemical stability of these drugs was determined under various conditions and the methods have shown adequate separation for their enantiomers and degradation products. In addition, degradation products produced as a result of stress studies did not interfere with the detection of the drugs' enantiomers and the assays can thus be considered stability-indicating.

Voltammetric determination of nitrendipine on composite film modified electrode

This paper was focused on the use of electrochemical methods based on a novel composite film modified electrode for the pharmaceutical analysis. This modified electrode was fabricated by integration of room-temperature ionic liquids (1-butyl-3-methylimidazolium hexafluophosphate) and multi-walled carbon nanotubes with polymeric matrix (chitosan). This sensor showed good stability and high accumulation efficiency. Electrochemical behavior of nitrendipine at this electrode was investigated in detail. A sensitive cathodic peak was observed at −0.76 V on the modified electrode. Under the optimized conditions, the peak current was linear to nitrendipine concentration in the range of 4.0 × 10−7 ∼ 5.0 × 10−5 M, and the detection limit was estimated to be 1.0 × 10−7 M after an accumulation for 150 s on open circuit. In addition, the proposed method was applied to the determination of nitrendipine in real samples, and the recovery was from 97.6 to 102.5%.

Determination of nitrendipine in tablets by HPTLC-densitometry

Summary A sensitive, selective, precise, and stability-indicating high-performance thin-layer chromatographic method coupled with densitometric analysis has been developed for determination of nitrendipine both as the bulk drug and in pharmaceutical dosage forms. The active substance was extracted from tablets with methanol (recovery from 97 to 105%) and chromatographed on silica gel 60 F254 HPTLC plates in horizontal chambers with n-hexane–ethyl acetate–acetone, 6 + 3 + 2 (v/v), as mobile phase. UV densitometric analysis of nitrendipine was performed in absorbance mode at λ = 335 nm. The calibration plot was constructed in the range 0.025 to 0.150 µg µL–1 (corresponding to 0.5–3.0 µg spot–1) with good correlation (r ≥ 0.990) and expressed as a second-order calibration function. Determination of nitrendipine in tablets was characterized by good precision (1.94% < RSD < 6.62%) and accuracy (–3.0 < RSE < 5.12). The HPTLC–densitometric method was successfully used for identification of nitrendipine in the presence of its induced degradation products. Pure drug and tablet extract were subjected to acid and alkali hydrolysis, oxidation, UV degradation, and photodegradation. The degraded products were well resolved from the nitrendipine with different R F values.

HIGH PRESSURE LIQUID CHROMATOGRAPHIC DETERMINATION OF NITRENDIPINE IN HUMAN PLASMA AFTER SOLID PHASE EXTRACTION

A rapid and sensitive Reversed-Phase High Pressure Liquid Chromatographic (RP-HPLC) method has been developed for the quantitative determination of nitrendipine in human plasma. A Hypersil C18 150×4.6 mm, 5 μm analytical column was used with a mixture of CH3CN-H2O at a volume ratio 50:50 v/v. Detection was performed with a variable wavelength UV-VIS detector at 238 nm. The detection limit was 0.4 ng/mL. Nimodipine was used as internal standard (IS) at a concentration of 12 ng/mL. The statistical evaluation of the method was examined performing intra-day and inter-day calibration. Nitrendipine was extracted from human plasma matrices by Solid Phase Extraction (SPE) technique instead of conventional liquid-liquid extraction methods. Recovery of nitrendipine in spiked samples was 97.75±5.43. The method was applied to a preliminary pharmacokinetic study in which an oral dose of 20 mg of nitrendipine was given to eight healthy volunteers.