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

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.

INDIAN DRUGS ◽  
2012 ◽  
Vol 49 (12) ◽  
pp. 51-55
Author(s):  
S Kathirvel ◽  
◽  
K. Madhu Babu

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.


2012 ◽  
Vol 1 (8) ◽  
pp. 193-198 ◽  
Author(s):  
Chusena Narasimharaju Bhimanadhuni ◽  
Devala Rao Garikapati ◽  
Pasupuleti Usha

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 


INDIAN DRUGS ◽  
2012 ◽  
Vol 49 (10) ◽  
pp. 13-17
Author(s):  
V. V Kunjir ◽  
◽  
S. B. Jadhav ◽  
A. J Purkar ◽  
P. D. Chaudhari

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.


2010 ◽  
Vol 7 (1) ◽  
pp. 198-202 ◽  
Author(s):  
R. Shinde Sachin ◽  
I. Bhoir Suvarna ◽  
S. Pawar Namdev ◽  
B.Yadav Suman ◽  
M. Bhagwat Ashok

A Simple, fast and precise reversed phase high performance liquid chromatographic method is developed for the simultaneous determination of satranidazole and ofloxacin. Chromatographic separation of these drugs were performed on Kromasil C18column (250 x 4.6 mm, 5 µ) as stationary phase with a mobile phase comprising of 20 mM potassium dihydrogen phosphate: acetonitrile in the ratio of 60:40 (v/v) containing 0.1% glacial acetic acid at a flow rate of 1 mL/min and UV detection at 318 nm. The linearity of satranidazole and ofloxacin were in the range of 1.5 to 3.6 µg/mL and 1.0 to 2.4 µg/mL respectively. The recovery was calculated by standard addition method. The average recovery was found to be 100.63% and 100.02% for satranidazole and ofloxacin respectively. The proposed method was found to be accurate, precise and rapid for simultaneous determination of satranidazole and ofloxacin


Author(s):  
E. Amulya ◽  
N. Naveen Kumar ◽  
CH. Mounika ◽  
V. Kowmudi ◽  
N. Supriya ◽  
...  

A rapid and precise reverse phase high performance liquid chromatographic method has been developed for the validated of Trihexyphenidyl and Haloperidol, in its pure form as well as in tablet dosage form. Chromatography was carried out on a Altima C18 (4.6 x 150mm, 5μm) column using a mixture of Methanol: TEA Buffer pH 4.5: Acetonitrile (50:25:25) as the mobile phase at a flow rate of 1.0ml/min, the detection was carried out at 225 nm. The retention time of the Trihexyphenidyl and Haloperidol was 2.102, 3.537±0.02min respectively. The method produce linear responses in the concentration range of 15-75ppm of Trihexyphenidyland 37.5-187.5ppm of Haloperidol. The method precision for the determination of assay was below 2.0%RSD. The method is useful in the quality control of pharmaceutical formulations.


2011 ◽  
Vol 8 (3) ◽  
pp. 1206-1211
Author(s):  
Madhukar A. Badgujar ◽  
Satish G. Pingale ◽  
Kiran V. Mangaonkar

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.


2011 ◽  
Vol 2011 ◽  
pp. 1-6 ◽  
Author(s):  
Usmangani K. Chhalotiya ◽  
Kashyap K. Bhatt ◽  
Dimal A. Shah ◽  
Gautam R. Chauhan ◽  
Sunil L. Baldania

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.


Sign in / Sign up

Export Citation Format

Share Document