scholarly journals A Simple and Validated Reverse Phase HPLC Methodfor the Determination of Rabeprazole inPharmaceutical Dosage Forms

2010 ◽  
Vol 7 (2) ◽  
pp. 569-577 ◽  
Author(s):  
Uma Mahesh Karra ◽  
Sanjeeva Yarkala
Keyword(s):  
High Performance ◽  
Limit Of Detection ◽  
Hplc Method ◽  
Reverse Phase Hplc ◽  
Reverse Phase ◽  
Rp Hplc ◽  
Limit Of Quantitation ◽  
Tablet Formulations ◽  
Bulk Drug

A simple and rapid reverse phase high performance liquid chromatography (RP-HPLC) method was developed and validated for quantitative determination of rabeprazole in bulk drug samples and formulations. Rabeprazole was analyzed by using reverse phase LC-GC column (Inertsil ODS, 4.6 mm x 25 cm, 5 microns), with mobile phase consisting of methanol: water (78:22 v/v). The flow rate was set 1.0 mL/min and analysis was performed at wavelength 288 nm using Photo Diode Array (PDA) detector at ambient temperature. The method was validated and stability studies were conducted under different conditions. The retention time for rabeprazole was around 4.12 minutes. The calibration curves were linear (r≥0.9998) over a concentration range from 20.0 to 80.0 μg/mL. Limit of detection (LOD) and Limit of quantitation (LOQ) were 8 ng/mL and 24 ng/mL respectively. The developed method was successfully applied to estimate the amount of rabeprazole in tablet formulations.

scholarly journals Validated Reverse Phase HPLC Method for the Determination of Irinotecan in Pharmaceutical Dosage Forms

2007 ◽  
Vol 4 (1) ◽  
pp. 128-136 ◽  
Author(s):  
Murali Balaram V. ◽  
VENKATESWARA Rao J. ◽  
Ramakrishnag S. Sankar Ganesh G. ◽  
Balamurali Krishna T.
Keyword(s):  
High Performance ◽  
Limit Of Detection ◽  
Hplc Method ◽  
Reverse Phase Hplc ◽  
Reverse Phase ◽  
Pharmaceutical Dosage Forms ◽  
Rp Hplc ◽  
Limit Of Quantitation ◽  
Bulk Drug

A simple and rapid reverse phase high performance liquid chromatography (RP-HPLC) method was developed and validated for quantitative determination of irinotecan in bulk drug samples and formulations. Irinotecan was analyzed by using reverse phase cyano column (4.6 mmx25 cm, 5 microns), with mobile phase consisting of phosphate buffer: acetonitrile (75:25v/v), pH adjusted to 2.5 with phosphoric acid. The flow rate was set 0.8 mL/min and the analysis was performed at wavelength 225 nm using Photo Diode Array (PDA) detector at ambient temperature. The method was validated and stability studies were conducted under different conditions. The retention time for irinotecan was around 5.82 minutes. The calibration curves were linear (r≥ 0.9998) over a concentration range from 20.0 to 80.0 μg/mL. Limit of detection (LOD) and Limit of quantitation (LOQ) were 8 ng/mL and 24 ng/mL respectively. The developed method was successfully applied to estimate the amount of irinotecan in injection formulations.

scholarly journals A A RAPID AND SENSITIVE RP-HPLC METHOD FOR THE QUANTITATIVE ANALYSIS OF EMPAGLIFLOZIN IN BULK AND PHARMACEUTICAL DOSAGE FORM

2019 ◽  
pp. 60-65
Author(s):  
MADHURIMA BASAK ◽  
Santhosh Reddy Gouru ◽  
Animesh Bera ◽  
Krishna veni Nagappan
Keyword(s):  
Quantitative Analysis ◽  
High Performance ◽  
Dosage Form ◽  
Limit Of Detection ◽  
Hplc Method ◽  
Reverse Phase ◽  
Pharmaceutical Dosage Form ◽  
Rp Hplc ◽  
Limit Of Quantitation ◽  
Bulk Drug

Objective: The present study aims at developing an accurate precise, rapid and sensitive Reverse Phase High-Performance Liquid Chromatography (RP-HPLC) method for assessing Empagliflozin in bulk drug and in the pharmaceutical dosage form. Methods: The proposed method employs a Reverse Phase Shim Pack C18 column (250 mm × 4.6 mm id; 5 µm) using a mobile phase comprising of acetonitrile and water in the ratio of 60:40 v/v flushed at a flow rate of 1 ml/min. The eluents were monitored at 223 nm. Results: Empagliflozin was eluted at a retention time of 5.417 min and established a co-relation co-efficient (R2>0.999) over a concentration ranging from 0.0495-100µg/ml. Percentage recovery was obtained between 98-102% which indicated that the method is accurate. The Limit of Detection (LOD) and Limit of Quantitation (LOQ) were found at 0.0125µg/ml and 0.0495µg/ml, respectively. Conclusion: An RP-HPLC method which was relatively simple, accurate, rapid and precise was developed and its validation was performed for the quantitative analysis of empagliflozin in bulk and tablet dosage form (10 and 25 mg) in accordance to International Conference of Harmonization (ICH) Q2 (R1) guidelines. The proposed method may aid in routinely analyzing empagliflozin in pharmaceuticals.

"A New RP-HPLC Method for the Simultaneous Determination of Drotaverine Hydrochloride and Paracetamol in a Tablet Dosage Form"

2012 ◽  
Vol 4 (4) ◽  
pp. 1544-1549
Author(s):  
A J Vyas ◽  
J K Patel ◽  
J V Chavda ◽  
Bhandari A
Keyword(s):  
Correlation Coefficient ◽  
Limit Of Detection ◽  
Hplc Method ◽  
Rp Hplc ◽  
Limit Of Quantitation ◽  
Drotaverine Hydrochloride ◽  
Tablet Formulations ◽  
Bulk Drug ◽  
Tablet Dosage

A simple, precise, and accurate isocratic RP-HPLC method was developed and validated for determination of Drotaverine hydrochloride (DROT) and paracetamol (PCM) in bulk drug and tablet formulations. Isocratic RP-HPLC separation was achieved on a Varian Microsorb mv C18 column (250 4.6 mm id, 5 mm particle size) using the mobile phase acetonitrile: water: triethylamine (TEA) (55:45:0.3%) with the pH adjusted to 3.5 and orthophosphoric acid at a flow rate of 1.6 ml/min. The retention time of DROT and PCM were 3.2713 and 1.5735 minutes, respectively. The detection was performed at 230 nm and samples of 20 µl were manually injected. The method was validated for linearity, precision, accuracy, robustness, and specificity. The method was found to be linear in the concentration range of 2-16 µg/ml with a correlation coefficient of 0.9997 for DROT and 12.5-100 µg/ml with a correlation coefficient of 0.9992 for PCM. The Calculated Limit of detection (LOD) and Limit of Quantitation (LOQ) for DROT were 0.0872 and 0.2644 µg/ml, respectively, and for PCM 0.2965 and 0.8984 µg/ml, respectively. The accuracy (recovery) was found to be in the range of 99.13%-101.52% with RSD of 1.194% for DROT and 99.09%-100.33% for PCM with RSD of 1.096%.

scholarly journals Rapid, Sensitive and Accurate Method for Determination of Lafutidine Hydrochloride in Human Plasma by RP-HPLC Syste

2014 ◽  
Vol 26 ◽  
pp. 9-20
Author(s):  
Paras P. Vekariya ◽  
Hitendra S. Joshi
Keyword(s):  
Human Plasma ◽  
High Performance ◽  
Limit Of Detection ◽  
Solid Phase ◽  
Hplc Method ◽  
Array Detector ◽  
Reverse Phase ◽  
Rp Hplc ◽  
Limit Of Quantitation

Simple and rapid reverse phase high-performance liquid chromatography (RP-HPLC) method was developed and validated using Phenomenex Gemini c18 (4.6 x 250 mm, 5 µ) reverse phase column for the determination of LAF in human plasma, Solid Phase Extraction (SPE) technique was used for the extraction of analyte, detection was carried out by Photo Diode Array detector at 216 nm. Chromatographic resolution of the LAF was achieved within 4.6 min by using mobile phase Methanol and 5 mM Di-Potassium Hydrogen Phosphate Buffer (pH 9.5) (80:20, v/v), flow rate was 1.0 mL/min. Calibration curve was linear with correlation coefficient of 0.9996 in the range of 50-1000 ng/mL, Limit of Detection (LOD) and Limit of Quantitation (LOQ) were 10 ng/mL and 30 ng/mL respectively, intra and inter-day deviations were lower than 3.92% and 3.98% respectively. The overall mean recovery of LAF was 94.57%. No any endogenous constituents were found to interfere at retention time of the analyte. This new RP-HPLC method was successfully validated and may be applied to conduct bioavailability & bioequivalence studies of LAF.

scholarly journals RP-HPLC Method for the Simultaneous Estimation of Rosiglitazone and Gliclazide in Tablets

2009 ◽  
Vol 6 (4) ◽  
pp. 1188-1192 ◽  
Author(s):  
G. Rathinavel ◽  
U. Uma Nath ◽  
J. Valarmathy ◽  
L. Samueljoshua ◽  
C. Selvin Thanuja ◽  
...  
Keyword(s):  
Limit Of Detection ◽  
Ammonium Phosphate ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Reverse Phase Hplc ◽  
Reverse Phase ◽  
Rp Hplc ◽  
System Suitability ◽  
Tablet Dosage

A reverse phase HPLC method is described for the determination of rosiglitazone and gliclazide in tablet dosage form. Chromatography was carried on Phenomenix Gemini C18column using in mixture of ammonium phosphate buffer, Acetonitrile and methanol in the ratio 50: 35: 15 v/v as mobile phase at a flow rate 1 mL min-1and the effluent was monitored at 254 nm. The retention time for rosiglitazone was 3.74 and gliclazide 7.84 min. The limit of detection for rosiglitazone was 4.07μg/mL and gliclazide 1.19 μg/mL. The LOQ obtained for rosiglitazone was 12.33 μg/mL and 3.612 μg/mL. The percentage assay for rosiglitazone was 99.92% and gliclazide was 99.82%. The method was validated for accuracy precision and system suitability. The proposed method was fast accurate and precise so it can be used for regular quality control of the drug.

scholarly journals Development of simple and sensitive HPLC method for determination of glyphosate residues in soybean

2015 ◽  
Vol 3 ◽  
pp. 21-26
Author(s):  
Om Prakash Sharma ◽  
Nanthanit Pholphana ◽  
Nuchanart Rangkadilok ◽  
Preeda Parkpian ◽  
Jutamaad Satayavivad
Keyword(s):  
High Performance ◽  
Limit Of Detection ◽  
Hplc Method ◽  
Reverse Phase Hplc ◽  
Intermediate Precision ◽  
Soybean Sample ◽  
Relative Standard ◽  
Limit Of Quantitation ◽  
Residue Levels

The purpose of this study was to develop a simple and sensitive high performance liquid chromatography (HPLC) method for determination of glyphosate (GP) residues in soybean grains. From soybean matrix, glyphosate was extracted with a mixture of water and methanol (4:1, v/v) from soybean samples followed by protein precipitation with equal volume of methanol. No preconcentration and further clean up of the sample were required. Pre-column derivatization was carried out with excess amount of 9- fluorenylmethyl chloroformate (FMOC-Cl) in the presence of borate buffer. The gradient program developed in this method was successfully applied to a reverse phase HPLC system with a C18 column (ACE 5 μm 4.6 x 250 mm), and eluted with a mobile phase consisting of 50 mM phosphate buffer, pH 2.5, and acetonitrile at the flow rate of 0.8 ml/min and fluorescence detection. Parameters and conditions affecting extraction, derivatization reaction and chromatographic separation were systematically examined. Linearity of the method ranged from 0.005 - 1.0 μg/ml. The correlation coefficient (r2) of calibration curve for glyphosate in soybean sample was found to be 0.99929. The limit of detection (LOD) and limit of quantitation (LOQ) values were determined to be 0.125 mg/kg and 0.25 mg/kg, respectively. Average recovery was 95.2%. Repeatability and intermediate precision calculated on the basis of peak area were excellent and showed relative standard deviation ranged from 0.15 - 1.29% and 1.15 - 3.87%, respectively. The developed method has been successfully applied for determination of glyphosate residues in soybean grains obtained from Thailand and Nepal. Soybean samples (53) from two different lots were analyzed and glyphosate residues ranged from 0.23 mg/kg to 5.06 mg/kg. Almost 50% soybean samples contained nearly consistent residue levels in both lots but in remaining samples there was a significant variation of glyphosate levels between two lots. Relatively higher residues were detected in samples from Thailand (0.27-5.06 mg/kg) compared to Nepal (0.23-0.99 mg/kg). The results suggest that the proposed method can be used to determine glyphosate residues in foods derived from soybean and other crops such as corn, cotton, wheat, etc. where glyphosate is widely applied to these crops.

scholarly journals Isocratic Reverse-Phase HPLC Method for Determination of Aspirin, Paracetamol, and Naproxen

2021 ◽  
Author(s):  
Md. Mynul Hassan ◽  
Sung-Wook Nam
Keyword(s):  
High Performance ◽  
Hplc Method ◽  
Low Flow ◽  
Uv Detector ◽  
Reverse Phase Hplc ◽  
Reverse Phase ◽  
Elution Time ◽  
Rp Hplc ◽  
Inflammatory Drugs

Nonsteroidal anti-inflammatory drugs (NSAIDs), which block the activity of cyclooxygenase (COX) isoenzymes and inhibit the synthesis of prostaglandin, have been used for pain relief. We have developed a method to separate a mixture of three NSAIDs, such as aspirin, paracetamol, and naproxen, using reverse-phase high-performance liquid chromatography (RP-HPLC). An isocratic mobile phase consisting of acidic water and acetonitrile was selected to run at a low flow rate, such as 0.8 mL/min. The mixture of three NSAIDs was injected at a low volume into a C18 column that was 150 mm in length and characterized using a UV detector at 230 nm. We identified three peaks in the chromatogram indicating the three compounds. The elution time of the peaks was less than 10 minutes. To identify multiple peaks on the isocratic flow using a short column, further studies are required regarding the proposed method to generate microfluidic devices for nanoLC.

scholarly journals Optimization and validation of an RP-HPLC method for the estimation of 6-mercaptopurine in bulk and pharmaceutical formulations

2014 ◽  
Vol 50 (4) ◽  
pp. 793-797 ◽  
Author(s):  
Vanita Somasekhar
Keyword(s):  
Limit Of Detection ◽  
Pharmaceutical Formulations ◽  
Hplc Method ◽  
Detector Response ◽  
Reverse Phase Hplc ◽  
Reverse Phase ◽  
Limit Of Quantification ◽  
Rp Hplc ◽  
Accuracy And Precision

A reverse phase HPLC method is described for the determination of 6-mercaptopurine in bulk and tablets. Chromatography was carried on a C18 column using a mixture of acetonitrile and 0.05 mol/L sodium acetate buffer (10:90 v/v) as the mobile phase at a flow rate of 1 mL/min-1 with detection at 324 nm. The retention time of the drug was 3.25 min. The detector response was linear in the concentration of 0.01-5 μg/mL. The limit of detection and limit of quantification were 17 and 52 ng/mL respectively. The method was validated by determining its sensitivity, linearity, accuracy and precision. The proposed method is simple, economical, fast, accurate and precise and hence can be applied for routine quality control of mercaptopurine in bulk and tablets.

scholarly journals RP-HPLC Method for the Determination of Cinitapride in the Presence of its Degradation Products in Bulk Drug

2010 ◽  
Vol 7 (1) ◽  
pp. 311-319 ◽  
Author(s):  
S. M. N. Roy ◽  
Kiran V. Mangaonkar ◽  
A. Y. Desai ◽  
Santosh M. Yetal
Keyword(s):  
Degradation Products ◽  
Internal Standard ◽  
Hplc Method ◽  
Good Separation ◽  
Reverse Phase Hplc ◽  
Reverse Phase ◽  
Rp Hplc ◽  
Precision And Accuracy ◽  
Bulk Drug

A reverse phase HPLC method is described for the determination of cinitapride hydrogen tartrate in the presence of its degradation products in bulk drug. A drug was subjected to all stress conditions such as reduction, oxidation acidic and alkaline medium. Chromatography was recorded on an Intersil ODS-3 column using mixture of acetonitrile and phosphate buffer, pH adjusted to 6.7 in the ratio (70:30 v/v) as the mobile phase at the rate of 1.0 mL/min with detection at 260 nm. Glimepride was used as internal standard. The retention time of drug cinitapride was 3.8 min and glimepride an internal standard was 2.5 minute. The drug was found to degrade extensively in reduction conditions and mild degradation in the presence of in alkaline, acidic and oxidative but the drug was stable in thermal stress. The method was validated by determining its specificity, linearity, precision and accuracy. The developed method with good separation of all degradation products from drug could be successfully applied for the determination of cinitapride in the presence of its degradation products in the bulk drug. The proposed method is simple, fast, accurate and precise and hence applied for routine quality control of cinitapride in bulk drug. It can be used for analysis of samples during stability testing.

scholarly journals Development and Validation of a Rapid RP-HPLC Method for the Estimation of Esmolol Hydrochloride in Bulk and Pharmaceutical Dosage Forms

2010 ◽  
Vol 7 (3) ◽  
pp. 807-812 ◽  
Author(s):  
Vanita Somasekhar ◽  
D. Gowri Sankar
Keyword(s):  
Limit Of Detection ◽  
Hplc Method ◽  
Detector Response ◽  
Reverse Phase Hplc ◽  
Limit Of Quantification ◽  
Pharmaceutical Dosage Forms ◽  
Rp Hplc ◽  
Accuracy And Precision ◽  
Development And Validation

A reverse phase HPLC method is described for the determination of esmolol hydrochloride in bulk and injections. Chromatography was carried on a C18column using a mixture of acetonitrile, 0.05 M sodium acetate buffer and glacial acetic acid (35:65:3 v/v/v) as the mobile phase at a flow rate of 1 mL/min with detection at 275 nm. The retention time of the drug was 4.76 min. The detector response was linear in the concentration of 1-50 μg/mL. The limit of detection and limit of quantification was 0.614 and 1.86 μg/mL respectively. The method was validated by determining its sensitivity, linearity, accuracy and precision. The proposed method is simple, economical, fast, accurate and precise and hence can be applied for routine quality control of esmolol hydrochloride in bulk and injections.

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