Validated HPLC Method for the Determination of Nisoldipine

Abstract

Experimental Materials and reagentsNisoldipine was supplied from NODCAR, Egypt, and its pharmaceutical form Sular tablets were manufactured by Rizhao Highrun Biotechnology Co., Ltd, China. All reagents and chemicals of the highest purity and analytical grade were available. Potassium dihydrogen phosphate and HPLC grade methanol were purchased from VWR. Hexane sulphonic acid sodium salt was obtained from Sigma-Aldrich. A standard stock solution 100 µg/ml of Nisoldipine was prepared in 100 ml methanol as solvent. Working solutions were prepared separately by making serial dilutions from the standard solution to obtain calibration graph in the range of 5-30 µg/ml. These solutions were stored at 20°C. Once prepared, analyzed daily for inter and intra-day variations of the method. 20 µl of these solutions were injected into LC system and chromatographic. Chromatographic conditionsHigh performance liquid chromatography experiments were carried out using the model of LC system Agilent 1100 Series with degasser, quaternary pump, auto-sampler, column heater, UVdetector and Chemstation-software. The detector was set to scan from 200 to 500 nm and had a discrete channel set at 275 nm, which was the AbstractIn this study, novel high performance liquid chromatography methods which are described as a simple, selective, sensitive, precise and simultaneous analysis of Nisoldipine in bulk and commercial tablet formulation containing Nisoldipine. Good chromatographic separation was achieved using a specific column Agilent ZORBAX Eclipse Plus C18, 4.6×250 mm and a mobile phase consisting of methanol, 0.01 M potassium dihydrogen phosphate aqueous solution and 0.1 M Hexane sulphonic acid sodium salt (25:65:10, v/v) at pH 4.0 using orthophosphoric acid with a flow rate of 1.0 ml/min. The ultraviolet detector was set at a wavelength of 275 nm. Nisoldipine was eluted at 7.43 min. Due to the high precautions taken during the analysis, no extraneous materials were found to interfere. The linear range for Nisoldipine was 5-30 µg/ml. The linearity, precision, accuracy, robustness, limit of detection and limit of quantification of the proposed method were determined. Regression coefficients (r 2 ≥ 0.999), recovery (97.2-103.1%), the limit of detection (0.4 µg/ml) and the limit of quantification (1.0 µg/ml) were validated and found to be satisfactory. The proposed method is convenient for quantitative routine analysis and purity control of Nisoldipine in its bulk powder and dosage forms.

Nisoldipine in Several Aqueous and Non-Aqueous Cosolvent Solutions: Solubility Modeling and Preferential Solvation Research

“…A good separation result was realized by the use of an LP-C 18 reverse phase column C18, 4.6 × 250 mm, set to 303 K and a mobile phase comprising aqueous solutions of methanol, 0.1 M hexane sulfonic acid sodium, and 0.01 M potassium dihydrogen phosphate (25:10:65, v/v) at pH 4.0 using orthophosphoric acid with a flow rate of 1.0 mL·min –1 . The UV detector was adjusted at a wavelength of 275 nm . Three samples were taken at a desired temperature for a given equilibrated system, and analysis for each sample was made three times.…”

“…The UV detector was adjusted at a wavelength of 275 nm. 42 Standard uncertainties are 0.02 K for the determined temperature and 0.45 kPa for the atmospheric pressure; relative standard uncertainties are 0.0443 for the mole fraction solubility and 0.0002 for solvent mixtures in mass fraction. w, mass fraction of acetonitrile in the acetonitrile (w) + water (1 − w) mixture free of nisoldipine.…”

Chiral separation of calcium channel antagonists by SFC and HPLC using different immobilized chiral stationary phases

“…The first two drugs have one chiral center in their molecular structure, while the third one has a stereogenic axis. These drugs are prescribed as racemic mixtures 4–6 . The enantiomers of these drugs have different pharmacodynamic and pharmacokinetic properties after being administered in the human body, leading to dosage confusion.…”

“…Due to the above facts, US‐FDA, European Committee for Proprietary Medicinal Products, Pharmaceutical and Medical Devices Agencies of Japan, and Health Canada have banned the sale and marketing of all racemic drugs 10–12 . It is important to mention that it is necessary to separate the enantiomers of the racemic drugs and then market them for public use 13 …”

“…] prescribed as racemic mixtures. [4][5][6] The enantiomers of these drugs have different pharmacodynamic and pharmacokinetic properties after being administered in the human body, leading to dosage confusion. It is well documented that among the two enantiomers, one of them is pharmaceutically active and the other may be inactive or toxic, producing some side effects or toxicity and complications in the human body.…”