scholarly journals Development and validation of an RP-HPLC method for the simultaneous determination of Escitalopram Oxalate and Clonazepam in bulk and its pharmaceutical formulations

2012 ◽  
Vol 1 (8) ◽  
pp. 193-198 ◽  
Author(s):  
Chusena Narasimharaju Bhimanadhuni ◽  
Devala Rao Garikapati ◽  
Pasupuleti Usha
Keyword(s):  
Simultaneous Determination ◽  
High Performance ◽  
Pharmaceutical Formulations ◽  
Pharmaceutical Journal ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Validation Parameters ◽  
Tablet Dosage ◽  
Liquid Chromatographic

A Simple, efficient and reproducible reverse phase high performance liquid chromatographic method was developed and validated for the Simultaneous determination of Escitalopram oxalate and Clonazepam in combined dosage form. The separation was effected on a Hypersil ODS C18 column (250mm X 4.6mm; 5µ) using a mobile phase mixture of buffer and acetonitrile in a ratio of 50:50 v/v at a flow rate of 1.0ml/min. The detection was made at 240nm. The retention time of Escitalopram oxalate and Clonazepam was found to be 2.840± 0.007min and 4.007±0.006 min. Calibration curve was linear over the concentration range of 20-120µg/ml and 1-6µg/ml for Escitalopram oxalate and Clonazepam. All the analytical validation parameters were determined and found in the limit as per ICH guidelines, which indicates the validity of the method. The developed method is also found to be precise, accurate, specific, robust and rapid for the simultaneous determination of Escitalopram oxalate and Clonazepam in tablet dosage forms.DOI: http://dx.doi.org/10.3329/icpj.v1i8.11249 International Current Pharmaceutical Journal 2012, 1(8): 193-198 

REVERSE PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHIC METHOD FOR DETERMINATION OF REGORAFENIB IN TABLET DOSAGE FORM

INDIAN DRUGS ◽  
2018 ◽  
Vol 55 (06) ◽  
pp. 63-68
Author(s):  
R. Raut ◽  
◽  
A. Patil ◽  
V. K Munipalli ◽  
M. Patel ◽  
...  
Keyword(s):  
High Performance ◽  
Dosage Form ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Control Analysis ◽  
Reverse Phase ◽  
Ich Guidelines ◽  
Tablet Dosage ◽  
Liquid Chromatographic

A simple precise and rapid Reverse Phase High Performance Liquid Chromatographic (RP-HPLC) method has been developed for quantitative determination of Regorafenib in tablet dosage form. In this method Hypersil Gold (C18, 150mm× 4.6mm id, 3μ) column with mobile phase consisting of Trifluoroacetic acid (0.2% v/v) and Acetonitrile in the ratio of (50: 50 v/v) at 400C in an isocratic mode was used. The detection was carried out at 260 nm and 20μL injection volume was selected with the flow rate 1mL/min. The linearity range of Regorafenib shows concentration between 5-200 μg/mL. The regression coefficient obtained was 0.999. Retention time of Regorafenib was found to be 6.49 minutes. Acetonitrile and Water in the ratio of (3:1) was used as a diluent. The method was validated as per ICH guidelines and is simple, fast, accurate, precise and can be applied for routine quality control analysis of Regorafenib in tablet dosage form.

scholarly journals Development of a New High-Performance Liquid Chromatographic Method for the Determination of Ceftazidime

2008 ◽  
Vol 91 (4) ◽  
pp. 739-743 ◽  
Author(s):  
Andréia de Haro Moreno ◽  
Hérida Regina Nunes Salgado
Keyword(s):  
High Performance ◽  
High Performance Liquid Chromatographic ◽  
Reversed Phase ◽  
Hplc Method ◽  
Calibration Graph ◽  
Raw Material ◽  
Relative Standard ◽  
Validation Parameters ◽  
Liquid Chromatographic

Abstract A rapid, accurate, and sensitive high-performance liquid chromatographic (HPLC) method was developed and validated for the determination of ceftazidime in pharmaceuticals. The method validation parameters yielded good results and included range, linearity, precision, accuracy, specificity, and recovery. The excipients in the commercial powder for injection did not interfere with the assay. Reversed-phase chromatography was used for the HPLC separation on a Waters C18 (WAT 054275; Milford, MA) column with methanolwater (70 + 30, v/v) as the mobile phase pumped isocratically at a flow rate of 1.0 mL/min. The effluent was monitored at 245 nm. The calibration graph for ceftazidime was linear from 50.0 to 300.0 g/mL. The values for interday and intraday precision (relative standard deviation) were <1. The results obtained by the HPLC method were calculated statistically by analysis of variance. We concluded that the HPLC method is satisfactory for the determination of ceftazidime in the raw material and pharmaceuticals.

scholarly journals Simultaneous Determination of Simvastatin and Ezetimibe in Tablets by HPLC

2009 ◽  
Vol 6 (2) ◽  
pp. 541-544 ◽  
Author(s):  
D. Anantha Kumar ◽  
D. P. Sujan ◽  
V. Vijayasree ◽  
J. V. L. N. Seshagiri Rao
Keyword(s):  
Simultaneous Determination ◽  
High Performance ◽  
Ammonium Acetate ◽  
High Performance Liquid Chromatographic ◽  
Dosage Forms ◽  
Reverse Phase ◽  
Liquid Chromatographic Method ◽  
Tablet Dosage ◽  
Liquid Chromatographic

A reverse phase high performance liquid chromatographic method was developed for the simultaneous determination of simvastatin and ezetimibe in tablet dosage forms. The separation was effected on a C18 Supelcosil column (250 mm x 4.6 mm; 5µ) using a mobile phase consisting of 0.01 M ammonium acetate buffer and acetonitrile (35:65v/v) at a flow rate of 1 mL/min. The detection was made at 240 nm. The retention times for ezetimibe and simvastatin were 5.9 and 8.5 min respectively. Calibration curves were linear over the ranges of 0.5-40 µg/mL for simvastatin and 2.5-50 µg/mL for ezetimibe. The proposed method was validated as per the ICH and USP guidelines. The method is accurate and precise and found to be suitable for the quantitative analysis of both the drugs individually and in combination in tablet dosage forms.

scholarly journals Simple, Accurate and Efficient High Performance Liquid Chromatographic Method for Determination of Vandetanib in Bulk and in Pharmaceutical Forms

2021 ◽  
pp. 153-160
Author(s):  
M. Murali ◽  
P. Venkateswara Rao
Keyword(s):  
High Performance ◽  
Orthophosphoric Acid ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Pharmaceutical Dosage Forms ◽  
Ich Guidelines ◽  
Liquid Chromatographic Method ◽  
Tablet Dosage ◽  
Liquid Chromatographic

A simple, selective, linear, precise and accurate isocratic RP-HPLC method was developed and validated for rapid assay of Vandetanib, an anticancer drug, in both bulk and tablet dosage form. Elution at a flow rate of 1ml/min was employed on a symmetry C18 column at ambient temperature. The mobile phase consisted of acetonitrile, water and orthophosphoric acid in the ratio of 90:08:02 (v/v/v). Linearity was observed in concentration range of 50-200 ppm. The retention time for Vandetanib was 3.326 min. The method was validated as per the ICH guidelines. The proposed method can be successfully applied for the estimation of Vandetanib in pharmaceutical dosage forms. Moreover the detection alone was also verified through LC-MS of the Vandetanib drug using ESI method which provides future scope for study of this drug using LC-MS method also.

Development and Validation of Midostaurin Assay by RP-HPLC Method

2018 ◽  
Vol 11 (6) ◽  
pp. 4318-4322
Author(s):  
Abrar Ahmed ◽  
Tayyaba Mahtab ◽  
Sumaiyya Saleem
Keyword(s):  
Myeloid Leukemia ◽  
High Performance ◽  
Kinase Inhibitor ◽  
Pharmaceutical Formulations ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Liquid Chromatographic Method ◽  
Development And Validation ◽  
Liquid Chromatographic

Midostaurin is a multi-targeted protein kinase inhibitor that has been used for the treatment of acute myeloid leukemia.  Here, a rapid and precise reverse phase high-performance liquid chromatographic method has been developed for the validation of midostaurin, in its API form as well as in capsule dosage form. Chromatography was carried out on a X-Bridge C18 (4.6 x 250 mm, 5 µm) column using a mixture of methanol: water (75:25% v/v) as the mobile phase at a flow rate of 1.0 mL/min, the detection was carried out at 243nm and the retention time of the midostaurin was found to be 3.155. The method produce linear responses in the concentration range of 10-50 µg/mL of midostaurin. The method precision for the determination of assay was below 2.0 % RSD. The LOD and LOQ values obtained were 1.2 µg/mL and 3.8 µg/mL respectively. There were no significant changes observed upon changing chromatographic conditions indicating the method to be robust. Therefore this validated method can be useful in the quality control of bulk and pharmaceutical formulations of midostaurin. 

scholarly journals Simultaneous determination of ethinyl estradiol and drospirenone in oral contraceptive by high performance liquid chromatography

2013 ◽  
Vol 49 (3) ◽  
pp. 521-528 ◽  
Author(s):  
Viviane Benevenuti Silva ◽  
Angel Arturo Gaona Galdos ◽  
Cintia Maria Alves Mothe ◽  
Michele Bacchi Pallastrelli ◽  
Maria Segunda Aurora Prado ◽  
...  
Keyword(s):  
Simultaneous Determination ◽  
Mobile Phase ◽  
High Performance ◽  
Ethinyl Estradiol ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Elution Time ◽  
Liquid Chromatographic Method ◽  
Liquid Chromatographic

A simple, rapid, economical and reliable high performance liquid chromatographic method has been developed and successfully applied in simultaneous determination of ethinyl estradiol and drospirenone in coated tablets. The HPLC method was performed on a LiChroCART® 100RP column (125x4 mm i.d., 5 µm) with acetonitrile:water 50:50 (v/v) as mobile phase, pumped at a flow rate of 1.0 mL.min-1. The fluorescence detection for ethinyl estradiol was made at λex= 280 nm and λem= 310 nm and a UV detection for drospirenone was made at 200 nm. The elution time for ethinyl estradiol and drospirenone were 4.0 and 5.7 min, respectively. The method was validated in accordance to USP 34 guidelines. The proposed HPLC method presented advantages over reported methods and is suitable for quality control assays of ethinyl estradiol and drospirenone in coated tablets.

Development and Validation of a High Performance Liquid Chromatographic Method for Simultaneous Determination of Vitamins A and D3 in Fluid Milk Products

2015 ◽  
Vol 98 (2) ◽  
pp. 390-396 ◽  
Author(s):  
Yang Chen ◽  
Ravinder M Reddy ◽  
Wenjing Li ◽  
Ramesh R Yettlla ◽  
Salvador Lopez ◽  
...  
Keyword(s):  
Simultaneous Determination ◽  
High Performance ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Array Detector ◽  
Technology Standard ◽  
Development And Validation ◽  
Liquid Chromatographic ◽  
Fluid Milk

Abstract An HPLC method for simultaneous determination of vitamins A and D3 in fluid milk was developed and validated. Saponification and extraction conditions were studied for optimum recovery and simplicity. An RP HPLC system equipped with a C18 column and diode array detector was used for quantitation. The method was subjected to a single-laboratory validation using skim, 2% fat, and whole milksamples at concentrations of 50, 100, and 200% of the recommended fortification levels for vitamins A and D3 for Grade “A” fluid milk. The method quantitation limits for vitamins A and D3 were 0.0072 and 0.0026 μg/mL,respectively. Average recoveries between 94 and 110%and SD values ranging from 2.7 to 6.9% were obtainedfor both vitamins A and D3. The accuracy of the method was evaluated using a National Institute of Standards and Technology standard reference material (1849a) and proficiency test samples.

scholarly journals RP-HPLC Determination of Atomoxetine Hydrochloride in Bulk and Pharmaceutical Formulations

2011 ◽  
Vol 8 (4) ◽  
pp. 1958-1964 ◽  
Author(s):  
H. R. Prajapati ◽  
P. N. Raveshiya ◽  
J. M. Prajapati
Keyword(s):  
Flow Rate ◽  
High Performance ◽  
Pharmaceutical Formulations ◽  
High Performance Liquid Chromatographic ◽  
Reversed Phase ◽  
Hplc Method ◽  
Limit Of Quantification ◽  
Rp Hplc ◽  
Liquid Chromatographic

A reversed phase high performance liquid chromatographic (RP–HPLC) method was developed and subsequently validated for the determination of atomoxetine hydrochloride in bulk and pharmaceutical formulation. The separation was done by a PerkinElmer Brownlee analytical C8 column (260 mm x 4.6 mm, 5 µm) using methanol: 50 mM KH2PO2buffer (PH adjusted to 6.8 with 0.1 M NaOH), 80:20 v/v as an eluent. UV detection was performed at 270 nm at a flow rate 1.0 mL/min. The validation of the method was performed, and specificity, reproducibility, precision accuracy and ruggedness were confirmed. The correlation coefficient was found to be 0.997 for atomoxetine hydrochloride. The recovery was in the range of 99.94 to 100.98% and limit of quantification was found to be 5.707 µg/mL. The method is simple, rapid, selective and economical too and can be used for the routine analysis of drug in pharmaceutical formulations.

scholarly journals Validation and Stability Indicating RP-HPLC Method for the Determination of Sildenafil Citrate in Pharmaceutical Formulations and Human Plasma

2008 ◽  
Vol 5 (s2) ◽  
pp. 1117-1122 ◽  
Author(s):  
B. Prasanna Kumar Reddy ◽  
Y. Ramanjaneya Reddy
Keyword(s):  
Human Plasma ◽  
High Performance ◽  
Signal To Noise Ratio ◽  
Pharmaceutical Formulations ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Sildenafil Citrate ◽  
Rp Hplc ◽  
Liquid Chromatographic

A simple, selective, accurate reverse phase-high performance liquid chromatographic (RP-HPLC) method was developed and validated for the analysis of sildenafil citrate in pharmaceutical formulations. Chromatographic separation achieved isocratically on a C18column (Use Inertsil C18, 5μ , 150 mm x 4.6 mm) utilizing a mobile phase of acetonitrile/phosphate buffer (70:30, v/v, pH 7.0) at a flow rate of 0.8 mL/m with UV detection at 228 nm. The retention time was 4.087. The method is accurate (99.15-101.85%), precise (intra-day variation 0.13-1.56% and inter-day variation 0.30-1.60%) and linear within range 0.1-30 μg/mL (R2=0.999) concentration and was successfully used in monitoring left over drug. The detection limit of sildenafil citrate at a signal-to-noise ratio of 3 was 1.80 ng/mL in human plasma while quantification limit in human serum was 5.60 ng/mL. The proposed method is applicable to stability studies and routine analysis of sildenafil citrate in pharmaceutical formulations as well as in human plasma samples.

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