Simultaneous Stability-Indicating Determination of Phenylephrine Hydrochloride, Phenylpropanolamine Hydrochloride, and Guaifenesin in Dosage Forms by Reversed-Phase Paired-Ion High-Performance Liquid Chromatography

1983 ◽  
Vol 72 (1) ◽  
pp. 55-59 ◽  
Author(s):  
Gary W. Schieffer ◽  
David Emlyn Hughes
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Reversed Phase ◽  
Dosage Forms ◽  
Phenylephrine Hydrochloride ◽  
Stability Indicating ◽  
Phenylpropanolamine Hydrochloride ◽  
Simultaneous Stability

scholarly journals ANALYITCAL METHOD DEVELOPMENT AND VALIDATION OF A REVERSED-PHASE HIGHPERFORMANCE LIQUID CHROMATOGRAPHY FOR THE DETERMINATION OF MODAFINIL IN BULK AND PHARMACEUTICAL DOSAGE FORMS

2016 ◽  
Vol 9 (5) ◽  
pp. 177
Author(s):  
Bijithra Cholaraja ◽  
Shanmugasundaram P ◽  
Ragan G ◽  
Sankar Ask ◽  
Sumithra M
Keyword(s):  
Particle Size ◽  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Reversed Phase ◽  
Dosage Forms ◽  
Hplc Method ◽  
Rp Hplc ◽  
Development And Validation

ABSTRACTObjective: To development and validation of a reversed-phase high-performance liquid chromatography (RP-HPLC) for the determination of modafinilin bulk and pharmaceutical dosage forms.Methods: A simple, precise, rapid, and accurate RP-HPLC method was developed for the estimation of modafinil in bulk and pharmaceutical dosageforms. Xterra RP 18 (250 mm × 4.6 mm, 5 µ particle size) with a mobile phase consisting of methanol:water 70:30 V/V was used. The flow rate1.0 ml/min and the effluents were monitored at 260 nm. The retention time and recovery time was 12 minutes. The detector response was linear inthe concentration of 10-50 µg/ml. The respective linear regression equation being Y=452.1x+65237. The limit of detection and limit of quantificationwere 4.547 and 1.377 mcg, respectively. The method was validated by determining its accuracy, precision, and system suitability.Result: The objective of the present work is to develop simple, precise, and reliable HPLC method for the analysis of modafinil in bulk andpharmaceutical dosage forms. This is achieved using the most commonly employed Xterra RP 18 (250 mm × 4.6 mm, 5 μ particle size) columndetection at 260 nm. The present method was validated according to ICH guidelines.Conclusion: In this study, a simple, fast and reliable HPLC method was developed and validated for the determination of modafinil in pharmaceuticalformulations.Keywords: Modafinil, Reversed-phase high-performance liquid chromatography, Estimation, ICH guidelines, Tablets. 

scholarly journals A Validated specific Stability-Indicating Reversed-Phase High-Performance Liquid Chromatography Assay Method for L-Ornithine L-Aspartate and Silymarin, and their related Substances and its Application to Dissolution Studies

2020 ◽  
Vol 11 (03) ◽  
pp. 317-328
Author(s):  
Prasada Rao Kammela ◽  
Bhavani Podili ◽  
Mohan Seelam
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
Mobile Phase ◽  
High Performance ◽  
Reversed Phase ◽  
Dosage Forms ◽  
Assay Method ◽  
Active Components ◽  
Stability Indicating ◽  
Related Substances

The present study was aimed at the development and successive validation of a novel, simple, sensitive, and stability-indicating reversed-phase high-performance liquid chromatography (RP-HPLC) method for quantitative calculation of L-ornithine L-aspartate (LOLA) and Silymarin (SL), and also their relevant substances in bulk and pharmaceutical dosage forms. The chromatographic technic was optimized using the impurity-spiked solution. The separation of all the two active components and their impurities was achieved by a chromatographic method with an Agilent Eclipse XDB-C18, 150 × 4.6 mm, 3.5 μ column, using gradient elution with mobile phase A consisting of a mixture of 0.1% orthophosphoric acid and water and acetonitrile as mobile phase B. The instrumental settings included a flow rate of 1 mL/min for both related substances and assay, a detector wavelength of 225 nm, by using a PDA detector. The established method was validated according to the current ICH requirements. The detection limit and the limit of quantification for the two active components and their related impurities were established with respect to test concentration. The calibration graphs plotted were linear with a regression coefficient R2 andgt; 0.999, indicates the linearity of the method was within the limits. Recovery studies were satisfactory and the parameters, such as, specificity, linearity, accuracy, precision, and robustness were determined as part of the method validation. Moreover, using the same method dissolution study was performed on active pharma ingredients to estimate the recovery. The obtained results were within the range of acceptance criteria. These results suggest that the developed method was found to be applicable for routine analysis for testing chromatographic purity of LOLA and SL and it can be utilized for the calculation of both active ingredients and their impurities in tablet dosage forms.

scholarly journals DEVELOPMENT AND VALIDATION OF RAPID STABILITY-INDICATING HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR THE DETERMINATION OF LINAGLIPTIN AND EMPAGLIFLOZIN IN PURE AND DOSAGE FORMS

2020 ◽  
pp. 172-177
Author(s):  
RAGAA EL SHEIKH ◽  
WAFAA S HASSAN ◽  
EMANH YOUSSEF ◽  
ABDULRAHMAN Y HAMDI ◽  
NAIF AHMED BADAHDAH ◽  
...  
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
Correlation Coefficient ◽  
High Performance ◽  
Dosage Forms ◽  
Hplc Method ◽  
Limits Of Detection ◽  
Stability Indicating ◽  
Tablet Dosage

Objective: A new, simple, rapid, sensitive, and accurate stability-indicating high-performance liquid chromatography (HPLC) method was developed and validated for the quantitative determination of linagliptin (LNG) and empagliflozin (EMP) in pure and tablet dosage forms. Methods: An isocratic HPLC method, using a C18 reversed-phase column (150 mm×4.6 mm i.d., particle size 5 μm) with an isocratic binary mobile phase consisting of phosphate buffer and acetonitrile (65:35, v/v), was investigated to separate the drug from its stress degradation products. The flow rate was 1.0 mL/min at ambient temperature and photodiode array detector is used at 226 nm for detection. The developed method was validated for system suitability, linearity, accuracy, precision, limits of detection and quantitation, specificity, stability, and robustness. Results: The retention time of LNG and EMP was found to be 3.276±0.002 and 6.966±0.0006 min, respectively. The calibration curve was found to be linear with the equation y=158926.39X+11.139, with a correlation coefficient of R2=0.9991 for LNG and y=22688.45X+4.259, with a correlation coefficient of R2=0.9994 for EMP over a concentration range of 2.5–7.5 μg/mL and 5.0–15 μg/mL for LNG and EMP, respectively. The limits of detection were 0.29 and 0.48 μg/mL for LNG and EMP, respectively, and the limits of quantification were 0.89 and 1.5 μg/mL for LNG and EMP, respectively. The recovery values of this method are 101.11% and 101.48% for LNG and EMP, respectively, and the reproducibility is within 0.070 and 0.277 for LNG and EMP, respectively. Conclusion: The proposed method is a rapid stability-indicating HPLC method that can be applied for the determination of LNG and EMP in pure and tablet dosage forms.

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.

scholarly journals A STABILITY-INDICATING AND VALIDATED REVERSE-PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHIC METHOD FOR THE SIMULTANEOUS ESTIMATION OF PHENYLEPHRINE AND FEXOFENADINE IN BULK AND TABLET DOSAGE FORMS

2016 ◽  
pp. 144
Author(s):  
B.sai Kumar ◽  
Jyothi G ◽  
Sreenivasa Rao B
Keyword(s):  
Quality Control ◽  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Reversed Phase ◽  
Dosage Forms ◽  
Array Detector ◽  
Simultaneous Estimation ◽  
Stability Indicating ◽  
Pharmaceutical Industries

<p>ABSTRACT<br />Objective: A simple and accurate stability indicating reversed-phase high-performance liquid chromatography method was developed and validated<br />for the simultaneous estimation of phenylephrine and fexofenadine in pharmaceutical dosage forms.<br />Methods: Chromatography was carried out on an ODS C-18 column (4.6 mm×250 mm, 5 µ particle size) with a isocratic mobile phase composed of<br />orthophosphoric acid buffer, acetonitrile, (75:25% v/v) at a flow rate of 1 mL/minutes. The column temperature was maintained at 30°C and the<br />detection was carried out using a photodiode array detector at 210 nm.<br />Results: The retention times for phenylephrine and fexofenadine were 2.096 minutes and 4.241 minutes, respectively. The percentage recoveries<br />of phenylephrine and fexofenadine were 100.63% and 99.84%, respectively. The relative standard deviation for assay of tablets was found to be<br />&lt;2%. The detection and quantification limits were found to be 0.10 and 0.31 µg/mL for phenylephrine and 0.01 and 0.03 µg/mL for fexofenadine,<br />respectively.<br />Conclusion: Thus, the method was fast, accurate, precise, and sensitive; hence, it can be employed for routine quality control of tablets containing<br />both drugs in quality control laboratories and pharmaceutical industries.<br />Keywords: Phenylephrine, Fexofenadine, Stability indicating method, Validation method, Reversed-phase high performance liquid chromatography.</p>

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.

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