Development and Validation of Stability Indicating UPLC Method for Simultaneous Estimation of Phenylephrine and Fexofenadine in Suspension Dosage Form

2020 ◽  
Vol 13 (5) ◽  
pp. 5069-5074
Author(s):  
Rajitha G ◽  
Geetha Susmita Adepu
Keyword(s):  
Quality Control ◽  
Dosage Form ◽  
Orthophosphoric Acid ◽  
Simultaneous Estimation ◽  
Control Analysis ◽  
Relative Standard ◽  
Pharmaceutical Industries ◽  
Acquity Uplc ◽  
Development And Validation ◽  
Liquid Chromatographic

Phenylephrine and fexofenadine are widely used products for common cold and allergic conditions. In this study, a simple, reliable, sensitive and economical Ultra Performance Liquid Chromatographic (UPLC) method was developed and validated for the simultaneous estimation of phenylephrine and fexofenadine in suspension dosage form. Efficient chromatographic separation was achieved on Acquity UPLC HSS C18 x 1.8μm column with mobile phase consisting of orthophosphoric acid buffer (pH = 2.8) and acetonitrile (55:45% v/v) at a flow rate of 0.3ml.min-1 and 1μl injection volume. TUV detector was used and detection wavelength was 272nm. The retention times of phenylephrine and fexofenadine were found to be 1.347 and 1.536 ± 0.01 mins respectively. The percentage recoveries of phenylephrine and fexofenadine were 99.93% and 99.31% respectively. The relative standard deviation for assay was found to be <2. The detection and quantification limits were found to be 0.04 and 0.13μg/ml for phenylephrine and 0.21 and 0.65μg/ml for fexofenadine respectively. Thus, the developed UPLC method was simple, rapid, sensitive and economical and it can be applied for the routine quality control analysis of combined dosage forms in quality control laboratories and in pharmaceutical industries.

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF ABACAVIR SULPHATE AND LAMIVUDINE IN TABLET DOSAGE FORM BY RP-HPLC

INDIAN DRUGS ◽  
2015 ◽  
Vol 52 (08) ◽  
pp. 12-16
Author(s):  
S Vidyadhara ◽  
◽  
L. S Reddyvalam ◽  
T. Koduri ◽  
P. K. Borra ◽  
...  
Keyword(s):  
High Performance ◽  
Dosage Form ◽  
Method Development ◽  
Correlation Coefficients ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Development And Validation ◽  
Tablet Dosage ◽  
Liquid Chromatographic

A simple, accurate, precise high-performance liquid chromatographic (HPLC) method has been developed and validated for the simultaneous determination of abacavir sulphate (ABA) and lamivudine (LAM) in combined dosage form. Separation was performed on a C18 column [Agilent ODS UG 5 column, 250 mm x 4.5 mm], with methanol: water (50:50 V/V) isocratic elution using a flow rate of 1mL/min. Good sensitivity was observed with UV detection at 277 nm. After method development, the interference of other active compounds and excipients, repeatability and linearity, were investigated. Retention times of LAM and ABA were found to be 3.3 and 6.3 min, respectively. The method was validated over the range from 2.5-12.5 μg/mL for LAM and 5-25 μg/mL for ABA with correlation coefficients of 0.9997 and 0.9996, respectively. This method was shown to be accurate, robust, selective, linear, and repeatable and can be successfully employed in routine quality control for the simultaneous analysis of ABA and LAM in tablets.

scholarly journals Development and validation of new analytical method for the simultaneous estimation of daunorubicin and cytarabine in bulk and pharmaceutical dosage form

2021 ◽  
pp. 32-39
Author(s):  
Kankipati Benjimen ◽  
K. Thejomoorthy ◽  
P.Sreenivasa Prasanna
Keyword(s):  
Quality Control ◽  
Mobile Phase ◽  
Dosage Form ◽  
Simultaneous Estimation ◽  
Regression Equations ◽  
Control Test ◽  
Pharmaceutical Dosage Form ◽  
Precise Method ◽  
Development And Validation ◽  
Quality Control Test

A simple, Accurate, precise method was developed for the simultaneous estimation of the Daunorubicin and Cytarabine inhalation dosage form. Chromatogram was run through BDS C18 150 x 4.6 mm, 5m. Mobile phase containing 0.1% OPA: Acetonitrile taken in the ratio 60:40 was pumped through column at a flow rate of 1.0 ml/min. Temperature was maintained at 30°C. Optimized wavelength selected was 240nm. Retention time of Daunorubicin and Cytarabine were found to be 2.245 min and 2.813. %RSD of the Daunorubicin and Cytarabine were and found to be 0.6and 0.3 respectively. %Recovery was obtained as 99.39% and 99.26% for Daunorubicin and Cytarabine respectively. LOD, LOQ values obtained from regression equations of Daunorubicin and Cytarabine were 0.03, 0.10 and 0.31, 0.94 respectively. Regression equation of Daunorubicin is y = 2677x + 703.5, y = 2524x + 104.7 of Cytarabine.Retention times were decreased and that run time was decreased, so the method developed was simple and economical that can be adopted in regular Quality control test in Industries.  

scholarly journals Method development and validation for simultaneous estimation of amlodipine besylate and enalapril maleate in solid dosage form

2021 ◽  
Vol 8 (3) ◽  
pp. 129-133
Author(s):  
Manisha Masih
Keyword(s):  
Dosage Form ◽  
Method Development ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Solution Stability ◽  
Amlodipine Besylate ◽  
Enalapril Maleate ◽  
Solid Dosage ◽  
Development And Validation ◽  
Liquid Chromatographic

A rapid, sensitive, specific, accurate and precise high pressure liquid chromatographic method (HPLC) method involving UV detection has been developed for the determination and quantification of Amlodipine Besylate and Enalapril maleate in bulk and combined dosage form. The determination was carried out on a Phenomenex C18 column (Dimention : 250 x 4.6 mm, 5 μm). The sample was analysed using filtered and degassed mixture of methanol : 0.1N HCl (1:1) as mobile phase at a flow rate of 1ml/min and effluent was monitored at 218nm. The retention time for Amlodipine besylate was 7.6 min and for Enalapril maleate 3.2 min. Amlodipine besylate and Enalapril maleate showed a linear response in the concentration range of 10-50μg/ml. The correlation co-efficient ('r' value) for Amlodipine besylate and Enalapril maleate was 0.9992 and 0.9994, respectively. The method was validated in terms of linearity, precision, accuracy, specificity, robustness and solution stability. The proposed method can be used for routine analysis of Amlodipine Besylate and Enalapril maleate in bulk and combined dosage form

scholarly journals Development and validation of new analytical method for the simultaneous estimation of Netupitant and Palonosetron in bulk and pharmaceutical dosage form

2021 ◽  
pp. 27-35
Author(s):  
Pushpa Divya P ◽  
Raj Kumar kudari
Keyword(s):  
Quality Control ◽  
Retention Time ◽  
Dosage Form ◽  
Simultaneous Estimation ◽  
Regression Equations ◽  
Control Test ◽  
Pharmaceutical Dosage Form ◽  
Precise Method ◽  
Development And Validation ◽  
Quality Control Test

A simple, Accurate, precise method was developed for the simultaneous estimation of the Netupitant and Palonosetron in pharmaceutical dosage form. Retention time of Palonosetron and Netupitant were found to be 2.266 min and 2.805 min. %RSD of the Netupitant and Palonosetron were and found to be 0.8 and 1.1 respectively. %Recovery was obtained as 100.08% and 100.15% for Netupitant and Palonosetron respectively. LOD, LOQ values obtained from regression equations of Netupitant and Palonosetron were 1.63, 4.94 and 0.003, 0.010. respectively. Regression equation of Netupitant is y =11553x + 9661.and y = 51072x + 152.0. of Palonosetron. Retention times were decreased and that run time was decreased, so the method developed was simple and economical that can be adopted in regular Quality control test in Industries.

scholarly journals Development and Validation of RP-HPLC Method for the Simultaneous Estimation of Haloperidol and Trihexyphenidyl in API and Combined Tablet Dosage Form

2018 ◽  
Vol 3 (03) ◽  
pp. 36-40 ◽  
Author(s):  
E. Amulya ◽  
N. Naveen Kumar ◽  
CH. Mounika ◽  
V. Kowmudi ◽  
N. Supriya ◽  
...  
Keyword(s):  
High Performance ◽  
Dosage Form ◽  
Pharmaceutical Formulations ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Liquid Chromatographic Method ◽  
Development And Validation ◽  
Tablet Dosage ◽  
Liquid Chromatographic

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.

DEVELOPMENT AND VALIDATION OF A UV SPECTROPHOTOMETRIC Q-ABSORBANCE RATIO METHOD FOR SIMULTANEOUS ESTIMATION OF EPERISONE HYDROCHLORIDE AND ACECLOFENAC IN BULK AND TABLET DOSAGE FORM

INDIAN DRUGS ◽  
2018 ◽  
Vol 55 (11) ◽  
pp. 50-56
Author(s):  
M. Simoes ◽  
◽  
L. Almeida
Keyword(s):  
Dosage Form ◽  
Limit Of Detection ◽  
Ratio Method ◽  
Simultaneous Estimation ◽  
Absorbance Ratio ◽  
Ich Guidelines ◽  
Relative Standard ◽  
Limit Of Quantitation ◽  
Development And Validation ◽  
Tablet Dosage

A simple, sensitive, rapid, accurate, precise and economical Q-absorbance ratio method has been developed for the simultaneous estimation of eperisone hydrochloride and aceclofenac in combined dosage form. The solvent used was methanol:water (70:30 v/v). The iso-absorptive point was found to be 269.5 nm. Calibration curves were linear over a concentration range of 6-21 μg/ml for eperisone hydrochloride and 8-28 μg/mL for aceclofenac, respectively. The developed method was validated as per International Conference on Harmonization (ICH) guidelines for various parameters such as linearity, precision, accuracy, limit of detection and limit of quantitation. Accuracy of method was determined through recovery studies which were found to be 99.0% - 100.89 % for eperisone hydrochloride and 98.67% - 100.44 % for aceclofenac. Method was found to be reproducible with relative standard deviation (RSD) for intra-and inter-day precision less than 2% over the concentration range. The proposed method can be used for routine analysis of eperisone hydrochloride and aceclofenac in bulk and tablet dosage form.

scholarly journals A NEW STABILITY-INDICATING RP-HPLC-PDA METHOD FOR SIMULTANEOUS ESTIMATION OF TRIPLICATE MIXTURE OF RAMIPRIL, ATORVASTATIN AND CLOPIDOGREL IN TABLET DOSAGE FORM

2018 ◽  
Vol 10 (5) ◽  
pp. 90
Author(s):  
Subba Rao ◽  
B. Balaswami ◽  
P. Venkata Ramana ◽  
P. Sanjeeva ◽  
G. Srenivasulareddy
Keyword(s):  
Quality Control ◽  
Dosage Form ◽  
Simultaneous Estimation ◽  
Forced Degradation ◽  
Column Temperature ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Relative Standard ◽  
Quality Control Tool ◽  
Tablet Dosage

Objective: To develop a novel, accurate, precise and linear reverse phase high performance liquid chromatographic (RP-HPLC) method for simultaneous quantitative estimation of ramipril, atorvastatin and clopidogrel in Atamra-CV tablet and validate as per international conference on harmonization (ICH) guidelines and to perform the force degradation studies using the developed method.Methods: In the present work, the good chromatographic separation was achieved isocratically using a shim-pack HPLC Kromasil 150 mm x 4.6 mm, 5 m. m. And mobile phase consisting of 0.05 M potassium dihydrogen orthophosphate pH 3 adjusted with orthophosphoric acid and acetonitrile in the ratio (52:48), at flow rate 1 ml/min and column temperature (30 °C). The effluents obtained were monitored at 210 nm with the UV-visible detector.Results: The retention time of ramipril, atorvastatin and clopidogrel was found to be 2.893 min, 5.012 min and 6.102 min respectively. The linearity of ramipril, atorvastatin and clopidogrel was found in the range of 25-150 % and the correlation coefficient for ramipril, atorvastatin and clopidogrel were>0.999. The high recovery values (98%-101%) indicate a satisfactory accuracy. The low percent relative standard deviation (% RSD) values in the precision study reveals that the method is precise. The three-drug samples were subjected to stress conditions of acidic and alkaline hydrolysis, oxidation, photolysis and thermal degradation. The proposed method proved to be stability-indicating by resolution of the analytes from their forced-degradation products.Conclusion: The developed method is novel, simple, precise, rapid, accurate and reproducible for simultaneous estimation of ramipril, atorvastatin and clopidogrel tablet dosage form. Hence the proposed method may find practical applications as a quality-control tool in the simultaneous analysis of the three drugs in combined dosage forms in quality-control laboratories. The proposed method was made use of photodiode array (PDA) as a tool for peak identification and purity confirmation.

scholarly journals Liquid Chromatographic Determination of Cetirizine in Oral Formulations

2005 ◽  
Vol 88 (2) ◽  
pp. 424-427 ◽  
Author(s):  
Lisiane Bajerski ◽  
Simone G Cardoso ◽  
Isabel Fraçao Diefenbach ◽  
Marcelo Donadel Malesuik ◽  
Silvia Helena Miollo Borgmann
Keyword(s):  
Chromatographic Determination ◽  
Reversed Phase ◽  
Control Analysis ◽  
Solution Ph ◽  
Constant Flow Rate ◽  
Oral Formulations ◽  
Relative Standard ◽  
Development And Validation ◽  
Liquid Chromatographic

Abstract The development and validation of a reversed-phase liquid chromatographic (LC) method for the determination of cetirizine dihydrochloride in oral formulations are described. An isocratic LC analysis was performed on a reversed-phase C18 column (250 × 4.6 mm id, 5 μm particle size). The mobile phase was 1% orthophosphoric acid solution, pH 3.0–acetonitrile (60 + 40, v/v), pumped at a constant flow rate of 1.0 mL/min. Measurements were made at a wavelength of 232 nm. The calibration curves were linear over the range of 10–30 μg/mL (r2 = 0.9999). The relative standard deviation (RSD) values for intraday precision were 0.94 and 1.43% for tablets and compounded capsules, respectively. The RSD values for interday precision were 0.13 and 0.82% for tablets and compounded capsules, respectively. Recoveries ranged from 97.7 to 101.8% for tablets and from 98.4 to 102% for compounded capsules. No interferences from the excipients were observed. Because of its simplicity and accuracy, the method is suitable for routine quality-control analysis for cetirizine in tablets and compounded capsules.

scholarly journals Simultaneous Estimation of Paracetamol, Phenylephrine Hydrochloride and Triprolidine Hydrochloride by Second Order Derivative Spectroscopy

2019 ◽  
Vol 31 (12) ◽  
pp. 2931-2936
Author(s):  
Mukem Bhattarai ◽  
Hema Basnett ◽  
Ateeb Das ◽  
Pravat Manna ◽  
Debarupa Dutta ◽  
...  
Keyword(s):  
Dosage Form ◽  
Second Order ◽  
Order Derivative ◽  
Simultaneous Estimation ◽  
Control Analysis ◽  
Phenylephrine Hydrochloride ◽  
Ich Guidelines ◽  
Relative Standard ◽  
The Individual ◽  
Tablet Dosage

A simple, sensitive and reproducible second order derivative UV spectrophotometric method was developed for simultaneous estimation of mixture of paracetamol, phenylephrine hydrochloride and triprolidine hydrochloride in the tablet dosage form. The method utilizes second order derivative technique, which helps to isolate the individual peaks of the mixture drugs and overcome the problem of merging of mixture peaks with each other. For quantification of paracetamol, phenylephrine hydrochloride and triprolidine hydrochloride wavelength selected were 244, 276 and 297 nm, respectively. The method was linear over the concentration range of 5-40 μg/mL. Intra-day and inter-day precision were within acceptable range (percentage relative standard deviation 2.27 %). The percentage recovery was within the range between 97.22-99.43 %. The method was also found to be robust and rugged. The method stands validated as per ICH guidelines and hence, can be used for the routine quality control analysis of paracetamol, phenylephrine hydrochloride and triprolidine hydrochloride in the tablet dosage form.

scholarly journals ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF CURCUMIN AND CYCLOSPORINE BY RP-HPLC

2018 ◽  
pp. 26-33
Author(s):  
Neha Desai ◽  
Munira Momin ◽  
Upasana Singh ◽  
Tabassum Khan ◽  
Atul Sherje
Keyword(s):  
High Performance ◽  
Dosage Form ◽  
Method Development ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Rp Hplc ◽  
Relative Standard ◽  
Method Development And Validation ◽  
Precision Study ◽  
Development And Validation

Objective: The present work was undertaken with an aim to develop and validate a rapid reverse-phase high-performance liquid chromatography (RP-HPLC) method for the estimation of curcumin and cyclosporine in the capsule dosage form. Methods: The RP-HPLC method for the simultaneous estimation of curcumin and cyclosporine was developed using Agilent (Infinity 1260) HPLC system and Eclipse XDB-C18 (4.6 x 150 mm i.d., 5µ) stationary phase. The optimized mobile phase comprised of acetonitrile: water: methanol (50: 10: 40 v/v/v) pumped at a flow rate of 0.5 ml/min. Separation of drugs was achieved in an isocratic mode and elution was monitored using PDA detector at 214 nm. The method was validated as per ICH-Q2R1 guidelines. Results: Retention time of the curcumin and cyclosporine were found to be 3.073 min and 6.373 min with the correlation coefficient (R2) of 0.9993 and 0.998 respectively. The response of curcumin and cyclosporine was found linear in the concentration range of 8-48 μg/ml and 4-24 μg/ml respectively. The percent recovery values were found in the range of 97-103% indicating satisfactory accuracy of the method. The percent relative standard deviation (% RSD) values for the precision study was less than 2 which suggest that the method is precise. Conclusion: The proposed method was found accurate, precise and specific for the determination of curcumin and cyclosporine in bulk as well as in capsule dosage form. Thus, the present method can be used for routine analysis and quality control of curcumin and cyclosporine in bulk and capsule dosage form.

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