scholarly journals APPLICATION OF VALIDATED RP-HPLC METHOD FOR THE DETERMINATION OF ARMODAFINIL IN BULK AND FORMULATION

2017 ◽  
pp. 158-161
Author(s):  
Devi Ramesh ◽  
Mohammad Habibuddin
Keyword(s):  
Retention Time ◽  
Mobile Phase ◽  
Hplc Method ◽  
Reverse Phase Hplc ◽  
Reverse Phase ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Validation Parameters ◽  
Isocratic Mode

Objective: The objective of the present study is to develop and validate a simple, rapid, sensitive reverse phase HPLC method for the determination of Armodafinil present in bulk and its pharmaceutical formulations.Methods: The chromatographic separation was achieved by using Hypersil ODS C-18 (150 x 4.6 mm, 5µ) in an isocratic mode with mobile phase methanol: phosphate buffer 3.0 (60:40 %v/v) was used. The flow rate was 1 ml/min and effluent was monitored at 225 nm. The method was validated for validation parameters i.e. linearity, accuracy, precision and robustness according to ICH guidelines.Results: The retention time of Armodafinil was 4.2 min and the linearity range of the method was 500-20000ng/ml with regression (r2) coefficient 0.9998. The method was validated for precision, accuracy, robustness and which were found to be within the acceptable limits according to the ICH guidelines. Also, the method was successfully applied for the estimation of Armodafinil in the marketed formulation of Nuvigil and the recovery was found to be>98%.Conclusion: The developed method possess good selectivity, specificity, there is no interference found in the blank at a retention time of ARM and good correlation between the peak area and concentration of the drugs under prescribed conditions. Hence, the method can be applied for routine analysis of Armodafinil. 

scholarly journals RP-HPLC Determination of Raloxifene in Pharmaceuticl Tablets

2006 ◽  
Vol 3 (1) ◽  
pp. 60-64 ◽  
Author(s):  
P. Venkata Reddy ◽  
B. Sudha Rani ◽  
G. Srinu Babu ◽  
J. V. L. N. Seshagiri Rao
Keyword(s):  
Flow Rate ◽  
Retention Time ◽  
Mobile Phase ◽  
Dosage Forms ◽  
Hplc Method ◽  
Reverse Phase Hplc ◽  
Reverse Phase ◽  
Pharmaceutical Dosage Forms ◽  
Rp Hplc

A reverse phase HPLC method is developed for the determination of Raloxifene in pharmaceutical dosage forms. Chromatography was carried out on an inertsil C18 column using a mixture of acetonitrile and phosphate buffer (30:70 v/v) as the mobile phase at a flow rate of 1 mL/min. Detection was carried out at 290 nm .The retention time of the drug was 10.609 min. The method produced linear responses in the concentration range of 0.5-200 µg/mL of Raloxifene. The method was found to be applicable for determination of the drug in tablets.

Development of validated method for the determination of exemestane by using RP-HPLC

2018 ◽  
Vol 9 (1) ◽  
pp. 185
Author(s):  
Siva Sai Kiran B ◽  
Raja S
Keyword(s):  
Detection Limit ◽  
Retention Time ◽  
Mobile Phase ◽  
Reversed Phase ◽  
Chromatographic Peak ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Hplc Grade Water ◽  
Isocratic Mode

A novel RP-HPLC validated method for determination of Exemestane is developed. The chromatographic separation was done on Phenomenex Luna reversed phase C18 (150 mm x 4.6 mm, 5 μm) column in isocratic mode, using Acetonitrile: HPLC grade water (50:50, v/v) as mobile phase at 254 nm wavelength. Exemestane chromatographic peak is eluted with retention time 4.656 min. The linearity range was 5-30 μg/ml with correlation coefficient 0.999. The method was validated as per ICH Guidelines. The quantification and detection limit for estimation of Exemestane was found to be 0.365 and 1.926 μg/ml respectively. Recovery of Exemestane was found in the range of 98.0-102.0%. Keywords: RP-HPLC; Exemestane; Validation; Estimation

A VALIDATED RP-HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF PANTOPRAZOLE AND CINITAPRIDE IN A PHARMACEUTICAL FORMULATION

INDIAN DRUGS ◽  
2014 ◽  
Vol 51 (01) ◽  
pp. 27-33
Author(s):  
N. R Dighade ◽  
◽  
S. P. Padmane ◽  
A. V. Kasture
Keyword(s):  
Flow Rate ◽  
Retention Time ◽  
Mobile Phase ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Capsule Formulation ◽  
Reverse Phase Hplc ◽  
Reverse Phase ◽  
Rp Hplc ◽  
Effluent Flow Rate

The study describes a validated stability indicating reverse- phase HPLC method for the simultaneous estimation of pantoprazole and cinitapride in capsule formulation. The proposed RP-HPLC method utilizes an Eclipse XDB C18 Column (150 × 4.6 mm i.d., 5μm), optimum mobile phase consisting of 10 mM phosphate buffer: acetonitrile: THF in the ratio of 64:36:0.5 V/V (pH 3.5) V/V, effluent flow rate 1 mL/min and UV detection wavelength of 266 nm. The selected chromatographic conditions were found to effectively separate pantoprazole and cinitapride with retention time of 7.17 min and 3.56 min, respectively. Linearity for pantoprazole and cinitapride was found in the range of 2-30 μg/mL and 0.15- 2.28 μg/mL, respectively. The developed method was statistically validated for the linearity, accuracy, precision, robustness, ruggedness and specificity. The proposed method was found to be simple, accurate, precise, economical and specific. Therefore, it can be used for simultaneous analysis of these drugs in capsule formulation.

scholarly journals Validation of developed method by RP-HPLC for simultaneous estimation of famotidine and ibuprofen in human plasma and studying the stability of the drugs in plasma

2018 ◽  
Vol 12 (1) ◽  
pp. 34-48
Author(s):  
K. S Ashutosh ◽  
D. Manidipa ◽  
R. J. V. L. N. Seshagiri ◽  
S. D. Gowri
Keyword(s):  
Human Plasma ◽  
Mobile Phase ◽  
Simultaneous Estimation ◽  
Hplc Separation ◽  
Reverse Phase ◽  
Rp Hplc ◽  
The Stability ◽  
Sodium Dihydrogen ◽  
Isocratic Mode

The RP-HPLC separation was carried out by reverse phase chromatography on a Symmetry C18 (4.6 x 150 mm, 3.5 μm, make: XTerra) with a mobile phase composed of sodium dihydrogen ortho phosphate [pH 2.5] and acetonitrile in the ratio of 30:70 v/v in an isocratic mode at a flow rate of 1.2 mL/min. The run time was maintained for 8.0 min. The detection was monitored at 236 nm. The accuracy was calculated in human plasma and the % recovery was found 99.80 - 99.85 for famotidine and 99.56 -99.85.5 for ibuprofen and reproducibility was found to be satisfactory. The calibration curve for famotidine in human plasma was linear over 3.32 to 6.65 μg/mL and 100- 200 μg/mL for ibuprofen in human plasma respectively. The inter-day and intra-day precision in human plasma was found within limits. The proposed method has adequate sensitivity, reproducibility, and specificity for the determination of famotidine and ibuprofen in plasma. The LLOQ obtained by the proposed method in human plasma were 1.24 and 5.0 μg/mL for famotidine and ibuprofen respectively. The proposed method is simple, fast, accurate, and precise for the quantification of famotidine and ibuprofen in plasma as per the ICH guidelines.Kathmandu University Journal of Science, Engineering and TechnologyVol. 12, No. I, June, 2016, Page: 34-48

scholarly journals DETERMINATION OF CHROMATOGRAPHIC ASSAY AND VALIDATION OF OFLOXACIN IN BULK AND PHARMACEUTICAL DOSAGE FORM

2018 ◽  
Vol 11 ◽  
Author(s):  
Sumithra M
Keyword(s):  
Mobile Phase ◽  
Dosage Form ◽  
Chromatographic Method ◽  
Assay Method ◽  
Reverse Phase ◽  
Pharmaceutical Dosage Form ◽  
Ich Guidelines ◽  
Validation Parameters ◽  
The Mean

Objective: The objective of the study is simple, sensitive; eco-friendly reverse phase chromatographic method has been developed and validated for the quantitative determination of ofloxacin in bulk and marketed formulation. Method: The developed method was done using Hypersil silica C18 (250 mm × 4.6 mm, 5 μ particle size) as column and the mobile phase is containing water and methanol in the ratio of (10:90) vol/vol. The mobile phase pass at 1 ml/min flow rate and the eluted solution is measured at 270 nm using a PDA detector. Results: The assay method is linear from the concentration range of 5–30 μg/ml. The corelation coefficient is 0.9998. The mean percentage recovery for the developed method is found to be in the range of 98.4–100.6%. The developed method complies robustness studies. Conclusion: The validation of the developed method was done by as per the ICH guidelines. It obeys the linearity, accuracy, precision, and robustness studies. Validation parameters are within the limitations. The results of the developed process indicated the reverse phase chromatographic method is simple, accurate as well as precise, rapid and eco-friendly method for routine analysis of ofloxacin in bulk and its pharmaceutical dosage form.

scholarly journals RP-HPLC METHOD FOR THE ESTIMATION OF ZILEUTON IN TABLET FORMULATION

2021 ◽  
Vol 9 (1) ◽  
pp. 141-149
Author(s):  
Romana Mahivish ◽  
Manjunath SY ◽  
Hemant Kumar
Keyword(s):  
Chromatographic Analysis ◽  
Mobile Phase ◽  
Hplc Method ◽  
Tablet Formulation ◽  
Solution Stability ◽  
Uv Detector ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
System Controller

A simple, rapid, accurate and precise RP-HPLC method was developed and validated for the determination of zileuton in table dosage form. Chromatographic analysis of the drug was achieved on Cyberlab HPLC comprising of LC- 100P pump, a variable wavelength programmable LC-UV100 UV detector and SCL system controller.  Flowrosil C18 column (250 mm x 4.6 mm, 5 μ) as stationary phase with mobile phase consisting of Methanol: Acetonitrile: 1% GAA in the ratio of 70:10:20 v/v. The method showed a good linear response in the concentration range of 5-30 μg/ml with correlation coefficient of 0.9993. The flow rate was maintained at 1.0 ml/min and detection was carried out at 230 nm. The retention time was 3.12 min. The method was statistically validated for accuracy, precision, linearity, ruggedness, robustness, solution stability, selectivity and sensitivity. The results obtained in the study were within the limits of ICH guidelines and hence this method can be used for the determination of zileuton in tablet formulation.

scholarly journals Stability indicating RP-HPLC method for the estimation of flucloxacillin sodium in a tablet dosage form

2020 ◽  
Vol 1 (4) ◽  
pp. 95-100
Author(s):  
Sonalika Patro ◽  
S. Harshith Kumar ◽  
M. Barath kumar ◽  
E. Masthaniah ◽  
K. Sairam ◽  
...  
Keyword(s):  
Mobile Phase ◽  
Dosage Form ◽  
Theoretical Plate ◽  
Hplc Method ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
System Suitability ◽  
Precision Study ◽  
Tablet Dosage

A Simple, accurate and precise method was developed and validated for the determination of flucloxacillin sodium in its tablet dosage form. The separation was eluted on xterra c18 column (4.6x150mm, 5micron) using a mixture of octane buffer and methanol as mobile phase in a ratio of (30:70) which was pumped through column at a flow rate of  1ml/min. Optimised wavelength for flucloxacillin was 237nm, the retention time was 2.305minutes and the percentage purity was found to be 98.14%. System suitability parameters such as theoretical plate and tailing factor for flucloxacillin sodium was found to be 2991.64 and 1.90 respectively, the proposed method was validated as per ICH guidelines (ICH, Q2 AND (R1)) the method was found to be linear at the concentration range of 20-100µg/ml and the correlation coefficient (r2) value was found to be 0.9994 percentage RSD for precision was 0.9% and percentage RSD for ruggedness was 0.5%. The precision study was precise, robust and repeatable. The LOD and LOQ values are 2.98 and 9.98 respectively. Hence the suggested RP-HPLC method can be used for routine analysis for flucloxacillin sodium in tablet dosage form.

scholarly journals A Validated RP-HPLC Method for Simultaneous Estimation of Ciprofloxacin and Flucionolone in Pharmaceutical Formulation

2018 ◽  
Vol 6 (03) ◽  
pp. 48-51
Author(s):  
D. Mamatha ◽  
G. Naveen ◽  
Devi Singh
Keyword(s):  
Theoretical Plate ◽  
Hplc Method ◽  
Pharmaceutical Formulation ◽  
Assay Method ◽  
Plate Count ◽  
Simultaneous Estimation ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Validation Parameters

A simple, accurate, precise and sensitive RP-HPLC assay method have been validated for the simultaneous estimation of ciprofloxacin and flucionolone in pharmaceutical formulation by RP-HPLC .ciprofloxacin and flucionolone is separated using Develosil ODS HG-5 RP C18, 5μm, 15cmx4.6mm i.d. column at a flow rate of 0.8 ml/ min. Here resolution was good, theoretical plate count and symmetry was appropriate .The LOD and LOQ were calculated using statistical methods. The % RSD values were less than 1.The validation parameters, tested in accordance with the requirements of ICH guidelines, prove the suitability of this method. The method was successfully applied for determination of drug in tablets, wherein no interference from tablet excipients was observed, indicating the specificity of the developed method.The proposed method was found to be simple, precise, accurate, rapid, economic and reproducible for the estimation of ciprofloxacin and flucionolone in pharmaceutical formulation.

scholarly journals Stability-indicating HPLC-DAD method for the determination of empagliflozin

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Shilpi Pathak ◽  
Pradeep Mishra
Keyword(s):  
Hplc Method ◽  
Coefficient Of Determination ◽  
Forced Degradation ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Validation Parameters ◽  
Forced Degradation Studies ◽  
Tablet Dosage

Abstract Background A stability-indicating RP-HPLC method was developed and validated for the estimation of empagliflozin drug and its tablet dosage form using a DAD detector. The mobile phase consisted of methanol/acetonitrile/0.1%OPA (75:20:5). The peak was observed at 2.54 min using 222.0 nm absorption maxima. Results Calibration curve plot was found within the range of 10–50 µg/mL. The coefficient of determination (R2) was found to be 0.9990. Forced degradation studies were performed for the empagliflozin in various conditions, and the results were calculated as %RSD values and were found to be within the limits. Conclusion The method was validated as per ICH guidelines with respect to all validation parameters.

scholarly journals Validated RP-HPLC Method for the Determination of Ivabradine Hydrochloride in Pharmaceutical Formulation

2017 ◽  
Vol 9 (05) ◽  
Author(s):  
MD. Muzaffar -ur- Rehman1 ◽  
G. Nagamallika
Keyword(s):  
Mobile Phase ◽  
Dosage Forms ◽  
Hplc Method ◽  
Pharmaceutical Formulation ◽  
Intermediate Precision ◽  
Pharmaceutical Dosage Forms ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Bulk Drug

A simple, rapid, precise, and accurate RP-HPLC method for the estimation of Ivabradine Hydrochloride an anti-anginal agent, both as a bulk drug and in pharmaceutical formulation was developed. The chromatographic separation was achieved on a Thermosil C18 150 × 4.5 mm, 5μm column by using a mobile phase containing a mixture of methanol and phosphate buffer pH 6.5 in the ratio of 65:35 % v/v at a flow rate of 1ml/min and at an ambient temperature. The detection was monitored at a wavelength of 265nm. A clear chromatographic peak was identified with the retention time of 4.36 min and tailing factor of 1.23. The developed method was validated according to ICH guidelines with respect to specificity, linearity, accuracy, precision and robustness. The method shows a good linear relationship with correlation co-efficient of more than 0.992 in the concentration range of 30μg-150μg. The method showed mean % Recovery of 100.4% and %RSD for repeatability and intermediate precision was less than 2%. The proposed method can be used successfully for the quantitative determination of Ivabradine HCL in pharmaceutical dosage forms.

Sign in / Sign up

Export Citation Format

Share Document