scholarly journals Quantitative Estimation of Sorafenib Tosylate Its Pure Form and in Its Tablet Formulation by RP-HPLC Method

2013 ◽  
Vol 2013 ◽  
pp. 1-3 ◽  
Author(s):  
R. Kalaichelvi ◽  
E. Jayachandran
Keyword(s):  
High Performance ◽  
Quantitative Estimation ◽  
Hplc Method ◽  
Pure Form ◽  
Mobile Phase Composition ◽  
Chromatography Method ◽  
Rp Hplc ◽  
Liquid Chromatography Method ◽  
Isocratic Mode

A simple, accurate, specific reverse-phase, high-performance liquid chromatography method has been developed for the determination of sorafenib tosylate in its pure form and its tablets. In this method, sorafenib tosylate was eluted by isocratic mode using a Phenomenex Luna C18 column by a mobile phase composition of acetonitrile and water in the ratio of 82.5 : 17.5, v/v. The flow rate was 1.5 mL/min. The eluted drug was monitored at 265 nm and the method was found to be linear from 5 to 80 μg/mL. The method was validated by linearity, precision, accuracy, LOD, and LOQ. The accuracy report denotes that there is not any interference of additives used in the formulation.

scholarly journals DEVELOPMENT OF METHODS FOR DETERMINATION OF SPECIFIC IMPURITIES IN THE GLUTATIONION RESTORED SUBSTANCE

2019 ◽  
Vol 6 (6) ◽  
pp. 535-547
Author(s):  
K. A. Alexeeva ◽  
D. I. Pisarev ◽  
A. Yu. Malyutina ◽  
N. N. Boyko
Keyword(s):  
Amino Acids ◽  
High Performance ◽  
Hplc Method ◽  
Low Molecular Weight ◽  
Chromatography Method ◽  
Rp Hplc ◽  
Liquid Chromatography Method ◽  
Layer Chromatography ◽  
Better Than

Glutathione (γ-L-glutamyl-L-cysteinylglycine) is the most important low molecular weight intracellular thiol tripeptide consisting of three amino acids – glycine, cysteine and glutamic acid. In Russian pharmacopoeia there is no regulatory documentation for glutathione, therefore, the development of a pharmacopoeial item for the specified substance is a relevant problem.The aim of the article is the development of methods for determining foreign specific impurities in glutathione.Materials and methods. The substance of glutathione reduced (CAS 70-18-8, EC 2007254, Applichem, Germany) containing impurities, and a standard sample of reduced glutathione (Sigma Aldrich, Japan) were used as the objects of the study. The analysis was carried out by using a high-performance liquid chromatography method in the reverse phase version and a thin layer chromatography method. The chromatography using RP HPLC was performed after preliminary derivatization of glutathione and its specific impurities with dancil chloride. Specific impurities in glutathione are dipeptides and amino acids. Therefore, they, like glutathione, can react with dancil chloride. Dancil derivatives are formed, and they can be determined by chromatographic separation.Results. As a result of chromatography by the method of RP HPLC of derivatized dancil chloride glutathione it has been established that this reaction makes it possible to detect impurities in it. Glutathione derivatives are well separated by chromatography by implementing the method of RP HPLC and have different absorption maxima. The glutathione derivative had an absorption maximum at λmax=284 nm. The derivatives belonging to specific glutathione impurities absorb at λmax=288 nm and λmax=296 nm. The data obtained using RP HPLC were confirmed by TLC in the isopropanol-water (2:1) system. Three components were found out, one of which corresponds to glutathione, while two others are impurities.Conclusion. Methods for determining impurities in the glutathione substance using RP HPLC methods with preliminary derivatization with dancil chloride and TLC with ninhydrin detection have been worked out. A comparative analysis of the data obtained makes it possible to state that the OF-HPLC method with pre-column derivatization is more reliable, since it is more sensitive to impurities, and also makes it possible to study the UV profiles of impurity components better than the TLC method. Therefore, for the detection of impurities in the substance of glutathione, it is more preferable to use RP-HPLC with pre-column derivatization. The results of this study can be recommended for inclusion in the regulatory documentation on the substance of glutathione in the section “Impurities”.

scholarly journals Exploring RP-HPLC Method for analysis of Axitinib in Bulk and in-house Tablets

1970 ◽  
Vol 6 (2) ◽  
pp. 135-141
Author(s):  
Shailesh S Chalikwar ◽  
Satish D Kayande ◽  
Inderbir Singh ◽  
Atul A Shirkhedkar
Keyword(s):  
High Performance ◽  
Quantitative Estimation ◽  
Hplc Method ◽  
Array Detector ◽  
Diode Array Detector ◽  
Chromatography Method ◽  
Optimal Flow ◽  
Rp Hplc ◽  
Liquid Chromatography Method ◽  
Tablet Dosage

Axitinib is a tyrosine kinase Inhibiter. In a commenced analysis, a effortless and responsive high-performance liquid-chromatography method was developed and validated for the quantitative estimation of Axitinib in bulk and in-house tablet dosage form. The present method was developed and validated using LC-GC Qualisil BDS C18 (250 mm × 4.6 mm, 5 μm). The separation of Axitinib was employed using a methanol: water 85:15% v/vas a mobile phase at optimal flow rate 1 mL/min and column oven temperature 30°C. While, Axitinib was examined at 330 nm with a photo diode array detector; retention timewas found to be 3.23 min.The intended method was validated by ICH rules for the accuracy, precision, sensitivity, and ruggedness. The linearity was followed in the concentration range of 4 - 24 μg/ mL as demonstrated by correlation coefficient (r2) of 0.9994. The robustness of proposed method was assessed by purposelyvarying the chromatographic conditions. Consequently, the intended method can routinely be subjected for th estimation of Axitinib in bulk and in tablets formulation.

Assay and Dermatokinetics of Tetrahydrocurcumin Lipidic Nanostructures Using Reverse Phase-High Performance Liquid Chromatography

2021 ◽  
Vol 09 ◽  
Author(s):  
Priyanka Narula ◽  
Komal Saini ◽  
Megha Saini ◽  
Dinesh Singla ◽  
Anurag Singh Chauhan ◽  
...  
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Quantitative Estimation ◽  
Healing Process ◽  
Entrapment Efficiency ◽  
Hplc Method ◽  
Reverse Phase ◽  
Chromatography Method ◽  
Rp Hplc

Background: Envisaging the poor solubility (56ng/ml) and permeability of tetrahydrocurcumin (THCC), it was formulated into lipidic nanostructures to enhance its bioavailability upon topical application to promote the healing process for skin inflammatory disorders. Lack of literature on suitable method for determining THCC per se and nanoformulations prompted us to develop a RP-HPLC method to detect the drug in its nanostructures and in pig ear skin post dermatokinetics. Objective: The present investigation aimed to develop a simple, precise and RP-HPLC method for the quantitative estimation of THCC in prepared lipidic nanostructures, its ointment and in skin homogenate obtained post dermatokinetic study. Method: THCC encapsulated nanostructures and ointment were formulated using modified emulsification method and embedded into an ointment base to enhance its spreadability and improve patient compliance. A fast and sensitive reverse phase high performance liquid chromatography method was developed using a Hypersil BDS reverse phase C18 column (4.6 mm × 250 mm, 5 μm) with mobile phase comprising tetrahydrofuran (THF) and 1 mgmL-1 citric acid (4:6), at a flow rate of 1.0 mLmin−1 with a run time of 20 min. Result: THCC nanostructures were successfully prepared using spontaneous microemulsification method. THCC was detected at 282 nm and revealed two peaks which were attributed to the keto-enol tautomerism in the molecule with retention times of 6.23 min and 11.06 min respectively. The assay of THCC in nanostructures and ointment was found to be 98.30% and 99.98% with entrapment efficiency 77.00±2.74 %. The dermatokinetic studies revealed sufficient release of THCC from its ointment up till 24 hr with a concentration of 1382 μgcm-2, for causing a therapeutic effect. Conclusion: The method was found to be reproducible and robust as shown by low coefficient of variation and a constant analyte/IS ratio. It was successfully employed for the estimation of THCC assay in nanostructures and it’s ointment and dermatokinetic analysis in skin.

Development of a sulphurous acid thiolysis-high performance liquid chromatography method for the analysis of procyanidins in pine bark products

2020 ◽  
Vol 10 (9) ◽  
pp. 1581-1587
Author(s):  
Lei Shi ◽  
Chunqi Liang ◽  
Yongzhi Qi
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Hplc Method ◽  
Pine Bark ◽  
Epicatechin Gallate ◽  
Chromatography Method ◽  
Content Determination ◽  
Liquid Chromatography Method

A sulphurous acid thiolysis-HPLC method for the determination of procyanidins in pine bark products was established. The concentration of sulphurous acid is 1.2%, the concentration of benzyl mercaptan is 2%, the reaction temperature is 90 °C, and the reaction time is 60 minutes. Under these conditions, the preservative rates of catechin, epicatechin, epicatechin gallate and their benzyl sulfide derivatives were 89.7%, 86.2%, 95.4%, 63.1%, 64.6% and 73.5%, respectively. According to this study, the calculation method for the procyanidin content determination by the thiolysis-HPLC method was corrected.

scholarly journals Development and Validation of Novel RP-HPLC Method for the Simultaneous Determination of Remogliflozin and Vildagliptin in Bulk and in synthetic Mixture

2021 ◽  
pp. 338-349
Author(s):  
Drashti A. Mandale ◽  
Chainesh Shah ◽  
Rakesh Jatt
Keyword(s):  
Single Dose ◽  
Dose Regimen ◽  
High Performance ◽  
Sglt2 Inhibitor ◽  
Hplc Method ◽  
Synthetic Mixture ◽  
Chromatography Method ◽  
Drug Sample ◽  
Liquid Chromatography Method

Vildagliptin which is DPP-4 inhibitor and Remogliflozin which is SGLT2 inhibitor in single dose regimen lower blood glucose by separate, complementary mechanisms. Both are glucose dependent, accounting for the low risk of hypoglycaemia during treatment. There is no risk factors associated with this combination and moreover it is single dose regimen. The aim of the present study was to develop and validate a simple, rapid and reproducible gradient high performance reverse phase liquid chromatography method for the estimation of Remogliflozin and Vildagliptin in bulk drug sample and in synthetic mixture using Xterra® Waters C18 column (150 mm×4.6 mm, 5 µm) at 25°C with UV detection at 210 nm and for this gradient mode was used. The compounds were eluted gradiently at a flow rate of 1.0ml/min. The average retention times for Remogliflozin and Vildagliptin were 4.881 and 6.334 min, respectively. The calibration curves were linear (r2 =0.988) over the concentration range 10-200 µg/ml for Remogliflozin and 10-200 µg/ml for Vildagliptin. No spectral or chromatographic interferences from formulation excipients were found and hence it was successfully applied for the determination of Remogliflozin and Vildagliptin in bulk and in synthetic mixture. The accuracy of the proposed method was determined by recovery studies and found to be 98-101%. The proposed method was validated and results conformed to ICH parameters.

scholarly journals Development and validation for determination of lisinopril dihydrate in bulk drug and formulation using RP-HPLC method

2018 ◽  
Vol 3 (2) ◽  
pp. 14-18
Author(s):  
Zahid Zaheer ◽  
Sarfaraz Khan ◽  
Mohammad Sadeque ◽  
Hundekari G. I. ◽  
Rana Zainuddin
Keyword(s):  
High Performance ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Rp Hplc ◽  
Liquid Chromatographic Method ◽  
Bulk Drug ◽  
Development And Validation ◽  
Liquid Chromatographic ◽  
Isocratic Mode

A simple, reproducible and efficient reverse phase high performance liquid chromatographic method was developed for Lisinopril in bulk drug and formulation. A column having 150 × 4.6 mm in isocratic mode with mobile phase containing acetonitrile: phosphate buffer (70:30; adjusted to pH 3.0) was used. The flow rate was 0.8 ml/min and effluent was monitored at 216 nm. The retention time (min) and linearity range (μg/ml) for Lisinopril was (1.510) and (10-35). The developed method was found to be accurate, precise and selective for determination of Lisinopril in bulk and formulation.

RAPID HIGH PERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR THE DETERMINATION OF RALTEGRAVIR IN HUMAN SALIVA

INDIAN DRUGS ◽  
2019 ◽  
Vol 56 (09) ◽  
pp. 68-73
Author(s):  
K Vijaya Sri ◽  
M. Shiva Kumar ◽  
M. A. Madhuri ◽  
Suresha K. ◽  
Keyword(s):  
High Performance ◽  
Limit Of Detection ◽  
High Performance Liquid Chromatographic ◽  
Human Saliva ◽  
Hplc Method ◽  
Limit Of Quantification ◽  
Chromatography Method ◽  
Liquid Chromatography Method ◽  
Liquid Chromatographic

In this study, a high-performance liquid chromatographic method (HPLC) was developed, validated and applied for the determination of raltegravir in biological sample like saliva. Liquid- liquid extraction was performed for isolation of the drug and elimination of saliva interferences. Samples of saliva was extracted with 50µL of ortho phosphoric acid and 3ml of methanol was added and spiked with raltegravir. The chromatographic separation was performed on Agilent Eclipse C18 (100 mm × 4.6 mm, 3.5µm) column, by using 80:20 v/v acetonitrile: water as a mobile phase under isocratic conditions at a flow rate of 1.0 mL/min for UV detection at 240 nm. Retention time of raltegravir was found to be 1.030 min. Linearity was found to be in the range of 25-1000 ng/mL with regression equation y = 13864x + 40495 and correlation coefficient 0.999. The low % RSD value indicates the method is accurate and precise. The limit of detection (LOD) and limit of quantification (LOQ) were found to be 0.76 and 2.28 ng/mL, respectively. It can be concluded that this validated HPLC method is easy, precise, accurate, sensitive and selective for determination of raltegravir in saliva.

scholarly journals Quantitative estimation of trimazolin hydrochloride in pharmaceutical preparation by RP-HPLC method

2009 ◽  
Vol 63 (2) ◽  
pp. 87-93 ◽  
Author(s):  
Ivana Savic ◽  
Goran Nikolic ◽  
Vladimir Bankovic ◽  
Ivan Savic
Keyword(s):  
Phase Composition ◽  
Quantitative Determination ◽  
Mobile Phase ◽  
Quantitative Estimation ◽  
Pharmaceutical Preparation ◽  
Hplc Method ◽  
Mobile Phase Composition ◽  
Rp Hplc ◽  
Ich Guidelines

A sensitive and selective RP-HPLC method was developed and validated for the quantitative determination of trimazolin hydrochloride in nasal drops formulations. The mobile phase composition was water-acetonitrile (50:50, v/v) and the UV detection was carried out at 270 nm. Linearity range in the concentration range of 10 to 110 ?g cm-3. The method was tested and validated for various parameters according to ICH guidelines. The detection and quantization limits were found to be 1.45 and 4.8 ?g cm-3, respectively. The results demonstrated that the procedure for estimation of trimazolin hydrochloride in nasal drops formulations was accurate, precise and reproducible.

Development and Validation of a High-performance Liquid Chromatography Method with Ultraviolet Detection for the Determination of Flunitrazepam in Human Plasma

2009 ◽  
Vol 59 (12) ◽  
Author(s):  
Bela Kiss ◽  
Daniela-Saveta Popa ◽  
Marius Bojita ◽  
Felicia Loghin
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
Human Plasma ◽  
High Performance ◽  
Hplc Method ◽  
Simple Liquid ◽  
Chromatography Method ◽  
Liquid Chromatography Method ◽  
The Stability

A high performance liquid chromatography (HPLC) method was developed and validated for determination of flunitrazepam in human plasma. After a simple liquid-liquid extraction, the analyses were carried out on a ODS column with diode array detection at 330nm. The mobile phase consisted in a mixture of potassium dihydrogene phosphate/acetonitrile (40/60, v/v). The method showed good linearity, accuracy and precision. Advantages of this validated assay include a simple plasma extraction method, short analysis time and good sensitivity (LLOQ = 5ng/mL). The stability data indicated a potential instability of flunitrazepam in plasma at room temperature.

scholarly journals Development and Validation of Rapid and Sensitive HPLC Method for the Determination of Methotrexate in Human Serum

2010 ◽  
Vol 2 (1) ◽  
pp. 8-13 ◽  
Author(s):  
M Nagulu ◽  
V Uday Kiran ◽  
Y Narsimha Reddy ◽  
D Rama Krishna
Keyword(s):  
High Performance ◽  
Internal Standard ◽  
Hplc Method ◽  
High Dose ◽  
Chromatography Method ◽  
Quantitation Limit ◽  
High Doses ◽  
Liquid Chromatography Method ◽  
Development And Validation

Methotrexate competitively inhibits dihydrofolic acid reductase and thereby inhibits DNA synthesis and cellular replication.This study describes a simple and fast high-performance liquid chromatography method for the determination of methotrexate [MTX] in serum.samples were collected from adult cancer patients receiving high dose MTX at Mahathma Gandhi Memorial hospital (Warangal,AP.India) at various time intervals after the end of each infusion. Serum was deproteinized with trichloroacetic acid and the supernatant was injected into a 250×4.6 mm octadecylsilane column. Mobile phase was made of TRIS-phosphate buffer (pH 5.7): methanol: acetonitrile (70:20:10) with a flow rate of 1ml/min. Ultraviolet detection was done at 313 nm and at ambient temperature. Para aminoacetophenone was used as internal standard. Methotrexate and internal standard retention times were 4.6 and 9.5 minutes, respectively. Results showed that reproducibility (precision) of method within a day was 2.6 to 6 percent and between days was 5.5 to 9.5 percent. The recovery of the method was between 61.5 and 72.7 percent. The quantitation limit of the method for methotrexate was 0.1μM. This method is suitable for quantitation of methotrexate after infusion of high doses of this drug and has good accuracy, precision and quantitation limit. Key Words: Methotrexate; HPLC; Serum Concentration. DOI: 10.3329/sjps.v2i1.1693Stamford Journal of Pharmaceutical Sciences Vol.2(1) 2009: 8-13

Sign in / Sign up

Export Citation Format

Share Document