scholarly journals Determination of Rosuvastatin and Ezetimibe in a Combined Tablet Dosage Form Using High-Performance Column Liquid Chromatography and High-Performance Thin-Layer Chromatography

2010 ◽  
Vol 93 (4) ◽  
pp. 1222-1227 ◽  
Author(s):  
Susheel John Varghese ◽  
Thengungal Kochupappy Ravi
Keyword(s):  
Simultaneous Determination ◽  
Mobile Phase ◽  
High Performance ◽  
Dosage Form ◽  
Good Precision ◽  
Uv Detector ◽  
Solution Ph ◽  
Phase Quantification ◽  
Tablet Dosage

Abstract This paper describes validated HPLC and HPTLC methods for the simultaneous determination of rosuvastatin (ROS) and ezetimibe (EZE) in a combined tablet dosage form. The isocratic RP-HPLC analysis was performed on a Chromolith C18 column (100 6 mm id) using 0.1 (v/v) orthophosphoric acid solution (pH 3.5)acetonitrile (63 + 37, v/v) mobile phase at a flow rate of 1 mL/min at ambient temperature. Quantification was carried out using a photodiode array UV detector at 245 nm over the concentration range of 0.510 g/mL for ROS and EZE. The HPTLC separation was carried out on an aluminum-backed sheet of silica gel 60F254 layers using n-butyl acetatechloroformglacial acetic acid (1 + 8 + 1, v/v/v) mobile phase. Quantification was achieved with UV densitometry at 245 nm over a concentration range of 0.10.9 g/spot for ROS and EZE. The analytical methods were validated according to International Conference on Harmonization guidelines. Low RSD values indicated good precision. Both methods were successfully applied for the analysis of the drugs in laboratory-prepared mixtures and commercial tablets. No chromatographic interference from the tablet excipients was found. These methods are simple, precise, and sensitive, and are applicable for simultaneous determination of ROS and EZE in pure powder and tablets.

VALIDATED HPTLC METHOD FOR SIMULTANEOUS DETERMINATION OF OLMESARTAN MEDOXIMIL AND METOPROLOL SUCCINATE IN TABLET DOSAGE FORM

INDIAN DRUGS ◽  
2012 ◽  
Vol 49 (10) ◽  
pp. 13-17
Author(s):  
V. V Kunjir ◽  
◽  
S. B. Jadhav ◽  
A. J Purkar ◽  
P. D. Chaudhari
Keyword(s):  
Simultaneous Determination ◽  
Mobile Phase ◽  
High Performance ◽  
Dosage Form ◽  
Chromatographic Method ◽  
Metoprolol Succinate ◽  
Ich Guidelines ◽  
Tablet Dosage ◽  
Hptlc Method

A high performance thin layer chromatographic method has been developed for the simultaneous determination of olmesartan medoximil and metoprolol succinate from tablet dosage form. The mobile phase consisting of water-methanol-ammonium sulphate (4.5:4.5:1.5 v/v/v) and wavelength of detection 233 nm was used. The developed method was validated as per ICH guidelines.

scholarly journals DEVELOPMENT AND VALIDATION OF HIGH-PERFORMANCE LIQUID CHROMATOGRAPHIC METHOD FOR DETERMINATION OF DAPAGLIFLOZIN AND ITS IMPURITIES IN TABLET DOSAGE FORM

2019 ◽  
pp. 447-453
Author(s):  
CAROLINE GRACE A ◽  
PRABHA T ◽  
SIVAKUMAR T
Keyword(s):  
Mobile Phase ◽  
High Performance ◽  
Dosage Form ◽  
Chromatographic Method ◽  
High Performance Liquid Chromatographic ◽  
Good Precision ◽  
Liquid Chromatographic Method ◽  
Tablet Dosage ◽  
Liquid Chromatographic

Objective: The aim of the present work is the development of new, sensitive, specific, and accurate high-performance liquid chromatographic method for the separation and determination of dapagliflozin and its impurities in tablet dosage form. Methods: The chromatographic separation of drug and its impurities was achieved using Hypersil BDS C18 column (250 mm × 4.6 mm, 5 μ) with mobile phase consisted of mobile phase-A (Buffer pH 6.5) and mobile phase-B (acetonitrile:water 90:10) by gradient program at a flow rate of 1 mL/min with ultraviolet detection at 245 nm. Results: Dapagliflozin and its impurities A, B, C, D, E, and impurity-F were successfully eluted at the retention time of 16.95, 2.72, 7.82, 10.58, 21.11, 30.37, and 34.36 min, respectively, with good resolution. The method was validated according to the international conference on harmonization guidelines. The validation results showed good precision, accuracy, linearity, specificity, sensitivity, and robustness. Conclusion: Successful separation and determination of dapagliflozin and its six impurities were achieved by the proposed method. The developed method can be applied for the routine analysis of dapagliflozin and its impurities in pharmaceutical formulations.

A VALIDATED METHOD FOR THE DETERMINATION OF TAPENTADOL HYDROCHLORIDE IN BULK AND ITS PHARMACEUTICAL FORMULATION BY DENSITOMETRIC ANALYSIS

INDIAN DRUGS ◽  
2012 ◽  
Vol 49 (12) ◽  
pp. 51-55
Author(s):  
S Kathirvel ◽  
◽  
K. Madhu Babu
Keyword(s):  
Mobile Phase ◽  
High Performance ◽  
Dosage Form ◽  
Chromatographic Method ◽  
Glacial Acetic Acid ◽  
Calibration Plot ◽  
Pharmaceutical Dosage Form ◽  
Aluminum Plates ◽  
Tablet Dosage

Described in this manuscript is the first reported new, simple high performance thin layer chromatographic method for the determination of tapentadol hydrochloride in bulk and its tablet dosage form. The drug was separated on aluminum plates precoated with silica gel 60 F254 with butanol: water: glacial acetic acid in the ratio of 6:2:2 (v/v/v) as mobile phase. Quantitative analysis was performed by densitometric scanning at 254 nm. The method was validated for linearity, accuracy, precision and robustness. The calibration plot was linear over the range of 200-600 ng band -1 for tapentadol hydrochloride. The method was successfully applied to the analysis of drug in a pharmaceutical dosage form.

DEVELOPMENT AND VALIDATION OF NEW HPT LC METHOD FOR SIMULTANEOUS ESTIMATION OF RUPATIDINE FUMARATE AND MONTELUKAST SODIUM IN TABLET DOSAGE FORM

INDIAN DRUGS ◽  
2013 ◽  
Vol 50 (06) ◽  
pp. 29-35
Author(s):  
T Raja ◽  
◽  
A. L Rao
Keyword(s):  
Simultaneous Determination ◽  
High Performance ◽  
Dosage Form ◽  
Pharmaceutical Formulations ◽  
Solvent System ◽  
Simultaneous Estimation ◽  
Montelukast Sodium ◽  
Aluminum Plates ◽  
Tablet Dosage

A new simple high performance thin layer chromatographic method for simultaneous determination of rupatidine fumarate and montelukast sodium in bulk and tablet dosage form was investigated. Chromatographic separation of the drugs was performed on aluminum plates precoated with silica gel 60 F254 as the stationary phase and the solvent system consisted of acetone:methanol:toluene (2:3:5, V/V/V). Densitometric evaluation of the separated zones was performed at 286 nm and the method was validated. The Rf values and drug content of rupatidine fumarate and montelukast sodium were 0.57±0.02, 0.68±0.02 and 98.3%, 97.67% respectively. The calibration curves of peak area versus concentration, were linear from 50-300 ng per band for both rupatidine fumarate and montelukast sodium and the regression coefficient (r2 ) was greater than 0.99. The method was validated for linearity, accuracy, robustness and application for assay as per ICH guidelines. The study showed that the developed method was simple and accurate and would be suitable for the simultaneous determination of rupatidine fumarate and montelukast sodium in bulk and pharmaceutical formulations.

scholarly journals Simultaneous Determination of Paracetamol, Chlorzoxazone and Diclofenac Sodium in Tablet Dosage Form by High Performance Liquid Chromatography

2011 ◽  
Vol 8 (3) ◽  
pp. 1206-1211
Author(s):  
Madhukar A. Badgujar ◽  
Satish G. Pingale ◽  
Kiran V. Mangaonkar
Keyword(s):  
Simultaneous Determination ◽  
High Performance ◽  
Dosage Form ◽  
Diclofenac Sodium ◽  
High Performance Liquid Chromatographic ◽  
Control Analysis ◽  
Liquid Chromatographic Method ◽  
Tablet Dosage ◽  
Liquid Chromatographic

A simple, precise and rapid isocratic reverse phase high performance liquid chromatographic method was developed for the simultaneous determination of paracetamol, chlorzoxazone and diclofenac sodium from tablet dosage form. The chromatographic separation was performed on an inertsil C18column (250 mm × 4.6 mm i.d 5 µm particle size). Mobile phase consisted of a mixture of phosphate buffer (0.02 M KH2PO4, pH adjusted to 3.7 using orthophosphoric acid), acetonitrile and methanol in the ratio of (25: 25: 50) at a flow rate of 1.0 mL/min. The wavelength was set at 220 nm. The proposed method was validated for linearity, accuracy, precision, LOD and LOQ. The calibration was linear over the range of 50-150 µg/mL for paracetamol, 50-150 µg/mL for chlorzoxazone and 5-15 µg/mL for diclofenac sodium. The retention times were found as 2.8 min for paracetamol, 4.2 min for chlorzoxazone and 6.4 min for diclofenac sodium. The method can be easily adopted for quality control analysis.

scholarly journals Simultaneous Determination of Alprazolam and Fluoxetine Hydrochloride in Tablet Formulations by High-Performance Column Liquid Chromatography and High-Performance Thin-Layer Chromatography

2009 ◽  
Vol 92 (4) ◽  
pp. 1082-1088 ◽  
Author(s):  
Rashmin B Patel ◽  
Mrunali R Patel ◽  
Madhira B Shankar ◽  
Kashyap K Bhatt
Keyword(s):  
Simultaneous Determination ◽  
Mobile Phase ◽  
High Performance ◽  
Hplc Method ◽  
Uv Detection ◽  
Fluoxetine Hydrochloride ◽  
Phase Quantification ◽  
Tablet Formulations ◽  
Layer Chromatography

Abstract This paper describes validated HPLC and HPTLC methods for simultaneous determination of alprazolam (ALP) and fluoxetine hydrochloride (FXT) in pure powder and formulation. The HPLC separation was achieved on a Nucleosil C8 column (150 mm length, 4.6 mm id, 5 m particle size) using acetonitrilephosphate buffer pH 5.5 (45 + 55, v/v) as the mobile phase at a flow rate of 1.0 mL/min at ambient temperature. The HPTLC separation was achieved on an aluminum-backed layer of silica gel 60F254 using acetonetolueneammonia (6.0 + 3.5 + 0.5, v/v/v) as the mobile phase. Quantification in the HPLC method was achieved with UV detection at 230 nm over the concentration range 414 g/mL for both drugs, with mean recovery of 99.95 0.38 and 99.85 0.56 for ALP and FXT, respectively. Quantification in the HPTLC method was achieved with UV detection at 230 nm over the concentration range of 4001400 ng/spot for both drugs, with mean recovery of 99.32 0.45 and 99.78 0.81 for ALP and FXT, respectively. These methods are simple, precise, and sensitive, and they are applicable for the simultaneous determination of ALP and FXT in pure powder and formulations.

Development of LC Method for the Simultaneous Determination of Antidepressant Drug Combination Melitracen Hydrochloride and Flupentixol Dihydrochloride in their Combined Dosage Form

2011 ◽  
Vol 2011 ◽  
pp. 1-6 ◽  
Author(s):  
Usmangani K. Chhalotiya ◽  
Kashyap K. Bhatt ◽  
Dimal A. Shah ◽  
Gautam R. Chauhan ◽  
Sunil L. Baldania
Keyword(s):  
Simultaneous Determination ◽  
High Performance ◽  
Dosage Form ◽  
Antidepressant Drug ◽  
Potassium Dihydrogen Phosphate ◽  
Chemical Oxidation ◽  
Reversed Phase ◽  
Dihydrogen Phosphate ◽  
Tablet Dosage

A simple, specific and stability-indicating reversed-phase high-performance liquid chromatographic method was developed for the simultaneous determination of melitracen hydrochloride and flupentixol dihydrochloride in tablet dosage form. A Brownlee C-18, 5 μm column having 250×4.6 mm i.d. in isocratic mode, with mobile phase containing 0.025 M potassium dihydrogen phosphate: methanol (10 : 90, v/v; pH 7.3) was used. The flow rate was 1.0 mL/min, and effluents were monitored at 230 nm. The retention times of melitracen hydrochloride and flupentixol dihydrochloride were 7.75 min and 5.50 min, respectively. The linearity for melitracen hydrochloride and flupentixol dihydrochloride were in the range of 0.5–60 μg/mL. The recoveries obtained for melitracen hydrochloride and flupenthixol dihydrochloride was 99.81–100.77% and 99.42–100.12%, respectively. Both the drugs were subjected to acid and alkali hydrolysis, chemical oxidation, and dry heat degradation and photodegradation. The proposed method was validated and successfully applied to the estimation of melitracen hydrochloride and flupentixol dihydrochloride in combined tablet dosage form.

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