scholarly journals Stability-Indicating High-Performance Liquid Chromatography Assay for the Determination of Sulthiame in Pharmaceutical Dosage Forms

2016 ◽  
Vol 11 ◽  
pp. ACI.S38656 ◽  
Author(s):  
Ammar Haidar ◽  
Sofiane Kabiche ◽  
Elyes Majoul ◽  
Issa-Bella Balde ◽  
Jean-Eudes Fontan ◽  
...  
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Reversed Phase ◽  
Coefficient Of Determination ◽  
Pharmaceutical Dosage Forms ◽  
Reliable Determination ◽  
Stability Indicating ◽  
Relative Standard

A stability-indicating assay by reversed-phase high performance liquid chromatography method was developed and validated for the determination of sulthiame (STM). The chromatographic separation was achieved on a reversed-phase NovaPack C18 column and an isocratic mobile phase consisting of deionized watenmethanol (70:30, v/v). The flow rate was 1.0 mL/min (ultraviolet detection at 210 nm). The STM was separated within 2.83 min. The linearity of the method was demonstrated in the range of 20.0-200.0 μg/mL and a coefficient of determination of r 2 = 0.9999. The limits of detection and quantification were 4.2 and 9.5 μg/mL, respectively. The intraday and interday precisions were less than 1%. Accuracy of the method ranged from 98.3% to 101.7%, with a relative standard deviation of <1%. STM was degraded by accelerated breakdown in alkaline, acidic, or oxidative stress conditions. This method allows accurate and reliable determination of STM for drug stability assay in pharmaceutical studies.

scholarly journals Development and validation of reversed phase high performance liquid chromatography (RP-HPLC) for quantification of captopril in rabbit plasma

2020 ◽  
Author(s):  
Muhammad Fawad Rasool ◽  
Umbreen Fatima Qureshi ◽  
Nazar Muhammad Ranjha ◽  
Imran Imran ◽  
Mouqadus Un Nisa ◽  
...  
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
Mobile Phase ◽  
High Performance ◽  
Limit Of Detection ◽  
Reversed Phase ◽  
Rabbit Plasma ◽  
Rp Hplc ◽  
Relative Standard

AbstractTh accurate rapid, simple and selective reversed phase high performance liquid chromatography (RP-HPLC) has been established and validated for the determination of captopril (CAP). Chromatographic separation was accomplished using prepacked ODSI C18 column (250 mm × 4.6 mm with 5 μm particle size) in isocratic mode, with mobile phase consisting of water: acetonitrile (60:40 v/v), pH adjusted to 2.5 by using 85% orthophosphoric acid at a flow rate of 1 mL/min and UV detection was performed at 203 nm. RP-HPLC method used for the analysis of CAP in mobile phase and rabbit plasma was established and validated as per ICH-guidelines. It was carried out on a well-defined chromatographic peak of CAP was established with a retention time of 4.9 min and tailing factor of 1.871. The liquid–liquid extraction method was used for extraction of CAP from the plasma. Excellent linearity (R2 = 0.999) was shown over range 3.125–100 µg/mL with mean percentage recoveries ranges from 97 to 100.6%. Parameters of precision and accuracy of the developed method meet the established criteria. Intra and inter-day precision (% relative standard deviation) study was also performed which was less than 2% which indicate good reproducibility of the method. The limit of detection (LOD) and quantification for the CAP in plasma were 3.10 and 9.13 ng/mL respectively. The method was suitably validated and successfully applied to the determination of CAP in rabbit plasma samples.

scholarly journals SIMULTANEOUS DETERMINATION OF DIPHENHYDRAMINE, EPHEDRINE, NOSCAPINE, AND GLYCEROL GLYCOLATE USING STABILITY-INDICATING HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY: APPLICATION TO NOSCOF TABLETS

2019 ◽  
pp. 505-511
Author(s):  
PULAGURTHA BHASKARARAO ◽  
GOWRI SANKAR DANNANA
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Uv Light ◽  
Reversed Phase ◽  
Hplc Method ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Relative Standard ◽  
Validation Parameters

Objective: Noscof tablet is a fixed dosage combination formulation having diphenhydramine (DH), ephedrine (ED), noscapine (NP), and glycerol glycolate (GG). A sensitive, selective, accurate, precise, and stability-indicating reversed-phase high-performance liquid chromatography (RP-HPLC) method with photodiode array detection has been developed and validated for simultaneous analysis of DH, ED, NP, and GG in bulk drug and Noscof tablets. Methods: Reversed-phase chromatographic separation and analysis of DH, ED, NP, and GG were done on an Altima C18 column with 0.01 M KH2PO4 buffer (pH 3.5) and acetonitrile (50:50%, v/v) as mobile phase at 0.8 ml/min flow rate in isocratic mode. Detection was performed at 260 nm. The method was validated in harmony with International Conference on Harmonization (ICH) guidelines. The tablet sample solution was subjected to diverse stress conditions using ICH strategy such as hydrolytic degradation (neutral - with distilled water, alkaline - with 2 N NaOH, and acidic - with 2 N HCl), oxidation (with 10% H2O2), photodegradation (exposing to UV light), and dry heat degradation (exposing to 105°C). Results: Using the above stated chromatographic conditions, sharp peaks were obtained for ED, NP, DH, and GG with retention time of 3.272 min, 4.098 min, 5.467 min, and 6.783 min, respectively. Good regression coefficient values were obtained in the range of 2–12 μg/ml for ED, 3.75–22.5 μg/ml for NP, 3.125–18.75 μg/ml for DH, and 25–150 μg/ml for GG. The quantification limits were 0.181 μg/ml, 0.187 μg/ml, 0.246 μg/ml, and 1.114 μg/ml for ED, NP, DH, and GG, respectively. The values of validation parameters are within the acceptance limits given by ICH. The ED, NP, DH, and GG showed more percent of degradation in acid condition and less percent of degradation in the neutral condition. The peaks of degradants did not interfere with the peaks of analytes. ED, NP, DH, and GG were assessed with a good percentage of the assay (near to 100%) and low percent relative standard deviation (<2%) in Noscof tablets using the proposed method. Conclusion: The stability indicating RP-HPLC method developed was suitable for quantifying ED, NP, DH, and GG simultaneously in bulk as well as in tablet formulation.

scholarly journals Determination of metoprolol in pure and pharmaceutical dosage forms by spectrofluorometry and high performance liquid chromatography

2011 ◽  
Vol 17 (1) ◽  
pp. 25-31 ◽  
Author(s):  
Bilal Yilmaz ◽  
Kadem Meral ◽  
Ali Asci ◽  
Yavuz Organer
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Solvent System ◽  
Dosage Forms ◽  
Content Uniformity ◽  
Pharmaceutical Dosage Forms ◽  
Relative Standard ◽  
Limit Of Quantitation

In this study, a new and rapid spectrofluorometry and high performance liquid chromatography (HPLC) methods were developed for determination of metoprolol in pure and pharmaceutical dosage forms. The solvent system, wavelength of detection and chromatographic conditions were optimized in order to maximize the sensitivity of both the proposed methods. The linearity was established over the concentration range of 50-4000 ng ml-1 for spectrofluorometry and 5.0-300 ng ml-1 for HPLC methods. The intra- and inter-day relative standard deviation (RSD) was less than 4.14 and 3.86% for spectrofluorometry and HPLC, respectively. Limit of quantitation was determined as 30 and 5.0 ng ml-1 for spectrofluorometry and HPLC, respectively. No interference was found from tablet excipients at the selected assay conditions. The methods were applied for the quality control of commercial metoprolol dosage forms to quantify the drug and to check the formulation content uniformity.

Determination of β -Sitosterol with Chemical Course and Material Applications in Jatropha Seed Oil by High Performance Liquid Chromatography

2012 ◽  
Vol 577 ◽  
pp. 69-72 ◽  
Author(s):  
Shu Yu Liu ◽  
Anaerguli Maihemuti
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Seed Oil ◽  
Reversed Phase ◽  
Analytical Recovery ◽  
Relative Standard ◽  
The Mean ◽  
Jatropha Seed

A simple and rapid high performance liquid chromatography (HPLC) assay was developed to identify and measure theβ-sitosterol with chemical course and material applications in jatropha seed oil. The stigmasterol was isolated with a good selectivity by HPLC employing reversed phase C18 columns. The components were separated by mobile phase of methanol-water (99/1, v/v) and detected at 205nm. The quantitation of the stigmasterol was reproducible and the method relative standard deviation is 1.1%. The mean analytical recovery was 96.2%.

scholarly journals SIMULTANEOUS EVALUATION OF ABACAVIR SULFATE AS WELL AS LAMIVUDINE IN MEDICAL FORMULATIONS BY GRADIENT REVERSED-PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY TECHNIQUE

2018 ◽  
Vol 11 ◽  
Author(s):  
Srinivasan Ms
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Reversed Phase ◽  
Hplc Method ◽  
Pharmaceutical Dosage Forms ◽  
Simultaneous Evaluation ◽  
Tablet Formulations ◽  
Abacavir Sulfate

Objective: A precise, accurate, simple, and gradient reversed-phase high-performance liquid chromatography (HPLC) method was adapted for the determination of abacavir sulfate (ABV) in combination with lamivudine (LMV) having tablet formulations simultaneously. This method developed has been validated as per the guidelines of ICH.Method: Waters HPLC has been used in the method with a column named Zorbax C18 with the dimensions as 4.6 nm×150 mm, 3.5 μm. Phosphate buffer (PH - 3.9) was used as Eluent - A, Eluent - B was methanol, and water and methanol (50:50 v/v) were utilized as diluents. The rate of flow was 1.5 ml/min.Results: The wavelength of detection has been detected at about 270 nm. Linearity ranges of ABV and LMV were 88–266 μg/ml and 38–116 μg/ml, respectively. Retention times of ABV (3.66 min) and LMV (10.71 min) were determined. The values of the study of percentage recovery of ABV and LMV were determined to be within 98.3–99.2%.Conclusion: The estimation of ABV and LMV in all pharmaceutical dosage forms could be performed successfully by employing this method.

scholarly journals STABILITY-INDICATING METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF ROSUVASTATIN CALCIUM IN PHARMACEUTICAL DOSAGE FORM BY REVERSE PHASE-HIGH PERFORMANCE LIQUID CHROMATOGRAPHY

2020 ◽  
pp. 9-16
Author(s):  
AWDHUT PIMPALE ◽  
RAJENDRA KAKDE
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Reversed Phase ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Relative Standard ◽  
Tablet Formulations ◽  
Development And Validation ◽  
Rosuvastatin Calcium

Objective: The present work was focused on the development and validation of the reversed-phase high-performance liquid chromatography (RP-HPLC) method, which is simple, rapid, precise, accurate, sensitive, economical, and stability-indicating for the quantification of rosuvastatin calcium in bulk and tablet formulation. Methods: The separation was attained on reversed-phase Princeton (C18) column with dimensions (250 mm × 4.6 mm, 5μ) employing buffer, which is a mixture of water (pH 3.0, adjusted with orthophosphoric acid) and methanol in the ratio (20:80) v/v as mobile phase, at flow rate 1.0 ml/min. and detection was carried out at wavelength 240 nm. The retention time under the optimized condition of rosuvastatin calcium was found to be 2.844 min. Results: The linearity of the method was demonstrated in the concentration range of 6-16 µg/ml for rosuvastatin calcium with a correlation coefficient (r2) of 0.9999. The percentage relative standard deviation was ˂2% and percentage recovery was found to be 100.12-101.37% for rosuvastatin calcium. The assay of marketed tablet formulations was found to be 98.99%. Conclusion: The developed RP-HPLC technique was found to be simple, specific, sensitive, rapid, linear, accurate, precise, and economical and will be used for regular quality control of rosuvastatin calcium in bulk and tablet formulations.

High-Performance Liquid Chromatography Multiresidue Method for the Determination of N-Methyl Carbamates in Fruit and Vegetable Juices

2004 ◽  
Vol 67 (11) ◽  
pp. 2565-2569 ◽  
Author(s):  
CONSUELO SÁNCHEZ-BRUNETE ◽  
BEATRIZ ALBERO ◽  
JOSÉ LUIS TADEO
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Reversed Phase ◽  
Fruit And Vegetable ◽  
Multiresidue Method ◽  
Relative Standard ◽  
Fruit And Vegetable Juices ◽  
Postcolumn Derivatization

A rapid multiresidue method has been developed for the analysis of N-methylcarbamate insecticides (oxamyl, methomyl, propoxur, carbofuran, carbaryl, and methiocarb) in fruit and vegetable juices. The method is based on the adsorption of the N-methyl carbamates in Florisil and the subsequent extraction of pesticides using a low volume of acetone. Residue levels in juice were determined by reversed-phase high-performance liquid chromatography with fluorescence detection after postcolumn derivatization. The separation of carbamates is performed on a C8 column with water-methanol as mobile phase. Recovery studies were performed at 500-, 100-, and 10-ng/ml fortification levels, and average recoveries obtained for carbamates ranged from 79 to 109%, with relative standard deviations between 1.4 and 9.9%. The method was found to be linear over the range assayed from 10 to 1,000 ng/ml, and the detection limits for carbamates varied from 0.8 to 1.9 ng/ml.

scholarly journals A VALIDATED REVERSED-PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR SIMULTANEOUS DETERMINATION OF FIVE ANTIEPILEPTIC DRUGS USED IN THE TREATMENT OF LENNOX–GASTAUT SYNDROME IN THEIR PHARMACEUTICAL DOSAGE FORMS

2018 ◽  
Vol 11 (5) ◽  
pp. 167
Author(s):  
Sonia T Hassib ◽  
Hanaa M A Hashem ◽  
Marianne A Mahrouse ◽  
Eman A Mostafa
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
Simultaneous Determination ◽  
Antiepileptic Drugs ◽  
High Performance ◽  
Reversed Phase ◽  
Dosage Forms ◽  
Pharmaceutical Dosage Forms ◽  
Significant Difference

 Objective: Lennox–Gastaut syndrome (LGS) is mainly treated with antiepileptic drugs (AEDs) but using one AED is not sufficient to relieve all or even most patients. A combination of agents is usually preferred. In the current study, an isocratic, selective, sensitive, precise, and accurate reversed-phase high-performance liquid chromatography (RP-HPLC) method was developed for the simultaneous determination of rufinamide (RUF), lamotrigine (LAM), clonazepam (CLO), valproic acid (VAL), and diazepam (DIA) which are commonly used in the management of LGS in their dosage forms using lacosamide as internal standard.Methods: The method depends on using RESTEK C18 column (5 μm, 250 mm × 4.6 mm) and a mobile phase composed of acetonitrile:water (55: 45, v/v), pH = 3.3 adjusted with phosphoric acid. The method was conducted in an isocratic mode with a flow rate of 1ml/min and ultraviolet detection at 210 nm.Results: The linearity range was 2–40 μg/ml for RUF and DIA, 0.5–40 μg/ml for LAM and CLO, and 36–180 μg/ml for VAL.Conclusion: Statistical analysis revealed no significant difference between the results obtained and the official or reported ones for each cited drug. The method is simple to be easily implemented in quality control studies of the mentioned drugs in their pharmaceutical preparations.

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