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 ◽  
...  

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.

Author(s):  
M. Murali ◽  
P. Venkateswara Rao

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.


2008 ◽  
Vol 5 (s2) ◽  
pp. 1149-1153 ◽  
Author(s):  
A. Lakshmana Rao ◽  
B. N. V. Ravi Kumar ◽  
G. G. Sankar

A simple, rapid, sensitive and precise High Performance Liquid Chromatographic (HPLC) method has been developed for the estimation of rabeprazole in bulk and tablet dosage form. In this method RP-C18column (150 mm x 4.6 mm I.D, 5 µ m particle size) with mobile phase consisting of methanol and water in the ratio of 65:35 v/v in isocratic mode was used. The detection wavelength is 284 nm and the flow rate is 0.8 mL/min. Tinidazole is used as internal standard. In the range of 0.25-20 µ g/mL, the linearity of rabeprazole shows a correlation coefficient of 0.9999. The drug and internal standard were eluted at 4.41± 0.05 and 2.16± 0.04 min. respectively. The intra- and inter-day variation was found to be less than 1% showing high precision of the assay method. The detection limit was found to be 100 ng/mL. The mobile phase selected for the proposed method is simple, fast, accurate and precise and hence can be applied for routine quality control analysis of rabeprazole in bluk and its tablet dosage from.


INDIAN DRUGS ◽  
2012 ◽  
Vol 49 (05) ◽  
pp. 61-64
Author(s):  
A. L Rao ◽  
◽  
R. V Bhaskara

A reverse phase high performance liquid chromatographic method was developed and validated asper ICH guidelines for estimation of trandolapril and verapamil in combined tablet dosage form. Theseparation was obtained using a mobile phase consisting of acetonitrile and phosphate buffer adjustingpH to 3.0 in the ratio of 70:30 v/v and using Waters C18 (250 x 4.6 mm, 5 mcm) column maintained atambient temperature. The flow rate was 1.2 mL min-1 and UV detection was monitored at 215 nm. Theretention time (min) and linearity range (mcg mL-1) for trandolapril and verapamil were (5.12, 2.70) and(20-60, 20-60), respectively. The method validation results are within the acceptance criteria for precision,accuracy and linearity. The proposed method was found to be suitable for routine quality control ofmarketed formulation containing these APIs.


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.


2012 ◽  
Vol 1 (5) ◽  
pp. 98-102 ◽  
Author(s):  
Chusena Narasimharaju Bhimanadhuni ◽  
Devala Rao Garikapati ◽  
Chintha Srinivas

A reverse phase high performance liquid chromatographic method was developed for the determination of duloxetine hydrochloride in bulk and dosage form. The separation was effected on a kromasil ODS C18 column (250mmX4.6mm, 5?) using a mobile phase mixture of buffer and methanol in a ratio of 85:15 v/v at a flow rate of 1.0ml/min. The detection was made at 230nm. The retention time of duloxetine hydrochloride was found to be 3.443±0.06 min. Calibration curve was linear over the concentration range of 20-120?g/ml of duloxetine hydrochloride. The propose method was validated as per the ICH guidelines. The method was accurate, precise, specific and rapid found to be suitable for the quantitative analysis of the drug and dosage form.DOI: http://dx.doi.org/10.3329/icpj.v1i5.10281International Current Pharmaceutical Journal 2012, 1(5): 98-102


2016 ◽  
Vol 12 (3) ◽  
pp. 413-418
Author(s):  
Haixia Lv ◽  
Suying Ma ◽  
Xiao Wang ◽  
Xiaojun Shang

Purpose: To develop and validate a new, simple, sensitive and accurate high performance liquid chromatographic (HPLC) method for the simulataneous determination of matrine and secnidazole in suppositories.Methods: The method involved using a SinoChoom ODS-BP C18 column (5 ƒÊm, 4.6 mm ~ 200 mm) and mobile phase consisting of  acetonitrile.triethylamine (0.05 %) in 0.025 mol/L KH2PO4 (20:80, v/v).The flow rate was 1 mL/min and detection was monitored at 210 and 311 nm for matrine and secnidazole, respectively. Total run time was 10 min and the column was maintained at 35 oC.Results: The excipients in the suppository did not interfere with the drug peaks. Matrine was eluted at a retention time (RT) of 4.30 min while linearity for the quantification of drug was obtained in the concentration range of 10.0 - 100.0 ƒÊg/mL (r2 = 0.9991). Secnidazole was eluted at a retention time (tr) of 6.69 min and linearity for the quantification of the drug was obtained in the concentration range of 10.0 - 150.0 ƒÊg/mL (r2 = 0.9993). Intra- and inter-day variations were < 1.0 % for both matrine andsecnidazole.Conclusion: The developed HPLC method was validated according to International Conference on Harmonisation (ICH) guidelines and proved to be suitable for the simultaneous determination of matrine and secnidazole in suppositories.Keywords: Matrine, Secnidazole, Suppository, HPLC, Assay


1970 ◽  
Vol 1 (4) ◽  
pp. 77-80
Author(s):  
Chusena Narasimha Raju Bhimanadhuni ◽  
Devala Rao Garikapati ◽  
Swetha Karamsetty

A reverse phase high performance liquid chromatographic method was developed for the determination of Modafinil in bulk and dosage form. The separation was effective on a Hypersil ODS C18 column (250 mm x 4.6 mm; 5μ) using a mobile phase mixture of Buffer:Acetonitrile in a ratio of 55:45 (v/v) at a flow rate of 1.0ml/min. The detection was made at 220nm. The retention time of modafinil was found to be 4.80±0.06 min. Calibration curve was linear over the concentration range of 20-120μg/ml of modafinil. The proposed method was validated as per the ICH guidelines. The method was accurate, precise, specific and rapid and thus found to be suitable for the quantitative analysis of modafi-nil in the bulk and dosage form.Key Words: Method development; validation; Modafinil; Tablets; Hypersil C18 Column; RP-HPLC.DOI: http://dx.doi.org/10.3329/icpj.v1i4.10062International Current Pharmaceutical Journal 2012, 1(4): 77-80 


2015 ◽  
Vol 13 (1) ◽  
pp. 51-56 ◽  
Author(s):  
Md Abdullah Al Mahmud ◽  
Subrata Bhadra ◽  
Afroza Haque ◽  
Md Elias Al Mamun ◽  
Syed Shabbir Haider

This paper describes a simple, sensitive and selective high performance liquid chromatographic (HPLC) method for the separation and determination of gliclazide (GLI) and enalapril (ENA) maleate simultaneously in tablet dosage forms. The chromatographic separation was performed on an ODS column (250 mm × 4.6 mm i.d., 5 ?m particle size) at 40 ± 0.5°C, with a mobile phase composed of phosphate buffer (pH 4.4), acetonitrile and methanol in the ratio of 45:40:15, (v/v/v). The flow rate was maintained at 1.5 ml/min, injected volume was 20 ?l and detection wavelength was 217 nm. The method was validated according to ICH Q2 (R1) guidelines and found to be linear over a range of 40-120 ?g/ml (R2 = 0.991) and 2.5-7.5 ?g/ml (R2 = 0.998) for gliclazide and enalapril maleate, respectively. The proposed method was applied successfully for the assay of these two drugs in their combined inhouse developed tablet formulations and could be applicable for routine quality control analysis. DOI: http://dx.doi.org/10.3329/dujps.v13i1.21859 Dhaka Univ. J. Pharm. Sci. 13(1): 51-56, 2014 (June)


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