scholarly journals Development and Validation of Stability indicating method for the estimation of Axitinib in tablet dosage forms by UPLC

2017 ◽  
Vol 5 (03) ◽  
pp. 01-06 ◽  
Author(s):  
Gorja Ashok ◽  
Sumantha Mondal
Keyword(s):  
Ultra Performance Liquid Chromatography ◽  
Dosage Forms ◽  
Chromatography Method ◽  
Pharmaceutical Dosage Forms ◽  
Stability Indicating ◽  
Stability Indicating Method ◽  
Liquid Chromatography Method ◽  
Development And Validation ◽  
Neutral Conditions ◽  
Tablet Dosage

A Stability Indicating Ultra-Performance Liquid Chromatography method was developed and validated for quantification of Axitinib in tablets. The chromatographic separation was done in an isocratic mode using the STD RP-18 Endcapped (50mm × 4.6mm, 2μ particle size) column. The mobile phase 0.1% OPA and acetonitrile 55:45 (%v/v) at the flow rate of 0.2mL/min and at ambient temperature was used. The wavelength used for detection was 249nm. The retention time for Axitinib was found to 1.03min. Axitinib was linear in the concentration range of 12.5μg/mL to 75μg/mL respectively. The developed method was validated and found to be accurate, specific and robust. The drug was subjected to the stressed conditions like acidic, basic, oxidative, photolytic, thermal and neutral conditions. The degradation results are found satisfactory. This method can be applied for the estimation of Axitinib in pharmaceutical dosage forms.

scholarly journals Development and Validation of Stability Indicating RP-HPLC Method for the Estimation of Cinacalcet Hydrochloride in Bulk and Their Formulations

2020 ◽  
Vol 10 (6) ◽  
pp. 6610-6618
Keyword(s):  
Dosage Forms ◽  
Hplc Method ◽  
Forced Degradation ◽  
Pharmaceutical Dosage Forms ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Cinacalcet Hydrochloride ◽  
Development And Validation ◽  
Tablet Dosage

A Simple, selective, accurate, precise, linear, and stability-indicating RP-HPLC method was developed and validated for the estimation of Cinacalcet hydrochloride in bulk and tablet dosage forms. Chromatographic separation was achieved on X-Terra Symmetry C18 (4.6 x 150mm; 5 m) with mobile phase containing Phosphate buffer: Acetonitrile (40:60 v/v) pH adjusted to 3.0 ±0.05 with diluted ortho-phosphoric acid. The flow rate was maintained at 0.9 mL/min. The eluent was monitored at 282 nm. Moreover, the retention time of Cinacalcet was 2.8 minutes. The method was validated for linearity, accuracy, precision, and robustness as per ICH guidelines. The developed method was found linear between 25-150 μg/ml, and the linear regression coefficient was 0.999. The % RSD values are less than 2 % indicating the accuracy and precision of the method. The percentage of recovery was obtained from 98-102%. The system suitability parameters were found to be within the limit. Forced degradation studies were conducted under various conditions. The proposed method is simple, rapid, precise, and accurate. It can be used for the quantitation of Cinacalcet hydrochloride in bulk and commercial pharmaceutical dosage forms.

scholarly journals Stability-indicating Reversed Phase-Ultra Performance Liquid Chromatography Method Development and Validation for Simultaneous Determination of Encorafenib and Binimetinib in Formulation

2020 ◽  
pp. 488-494
Author(s):  
Taduvai Venkata Raveendranath ◽  
Rajaiah Thangaraj Saravanakumar ◽  
Anjana Male
Keyword(s):  
Method Development ◽  
Detection System ◽  
Ultra Performance Liquid Chromatography ◽  
Reversed Phase ◽  
Simultaneous Estimation ◽  
Regression Equations ◽  
Chromatography Method ◽  
Stability Indicating ◽  
Stability Indicating Method ◽  
Liquid Chromatography Method

A simple, accurate and precise stability indicating method was developed for the simultaneous estimation of the encorafenib (ECRB) and binimetinib (BMTB) in a dosage form by UPLC. Chromatographic elution was processed through a HSS C18 (100 x 2.1 mm, 1.8m) reverse phase column and the mobile phase composition of 0.01N KH2PO4 buffer (3.5 pH) and acetonitrile in the proportion of 55:45 was processed thru a column at a flow rate of 1.0 ml/min. Temperature of the column oven was kept at 30.0°C and the wavelength maximum of detection system was set to 294 nm. Retention times of ECRB and BMTB were found to be 0.767 min and 1.130 min respectively. Repeatability of the method was determined in the form of %RSD and findings were 0.3 and 0.6 for ECRB and BMTB respectively. The percentage recovery of the method was found to be 99.59% and 99.70% for ECRB and BMTB respectively. LOD, LOQ values obtained from regression equations of ECRB and BMTB were 0.51, 1.55mg/ml and 1.47, 4.44 mg/ml respectively. Regression equation of ECRB was y = 6684.x + 18102 and BMTB was y = 13118x + 2159. Two analytes were subjected for acid, peroxide, photolytic, alkali, neutral and thermal degradation studies and the results shown that the percentage of degradation was found between 0.76% and 6.88%. Retention times and total run time of two drugs were decreased and the developed method was simple and economical. So, the developed method can be adopted in industries as a regular quality control test for the quantification of ECRB and BMTB.

scholarly journals Development and validation of stability indicating assay method for estimation of lumefantrine in bulk and tablet dosage form

2020 ◽  
Vol 11 (SPL4) ◽  
pp. 1921-1927
Author(s):  
Vijay H Ikale ◽  
Hemant K. Jain ◽  
Ashish B. Budhrani ◽  
Manoj S. Patil ◽  
Tikesh Agrawal ◽  
...  
Keyword(s):  
Chromatographic Analysis ◽  
Mobile Phase ◽  
Assay Method ◽  
Oxidation Condition ◽  
Stability Indicating ◽  
Stability Indicating Method ◽  
Degradation Studies ◽  
Development And Validation ◽  
Neutral Conditions ◽  
Tablet Dosage

Simple, precise, accurate, sensitive, economical, and rapid stability indicating method was developed for the estimation of Lumefantrine in bulk and tablets. Chromatographic analysis was performed on A Hibar C18 (4.6×250 mm, 5μm) column and mobile phase made up of acetonitrile: methanol (50:50 v/v); used for this study. The flow rate of the mobile phase was to 1.2 ml/min; the temperature of the column was adjusted to 40°C and UV analysis was carried out at 234 nm. The degradation studies were performed and the analytical method was validated as per ICH Q2R1 guideline. The Retention time of Lumefantrine was found to be 8.8 min. The developed method was found to be linear in the concentration range of 10-60 μg/ml. The value of the correlation coefficient between peak area and concentration was found to be 0.995. The value of % RSD was found to be within prescribed limits for precision studies which indicate reproducibility of the method. The values of LOD and LOQ were obtained at 14.54 and 44.07 μg/ml, respectively. The results of degradation studies indicate that the drug was found to be stable in acidic, basic, neutral, photolytic, and neutral conditions while degraded in oxidation condition. 

scholarly journals A NEW NP-UPLC METHOD FOR THE SEPARATION AND SIMULTANEOUS QUANTIFICATION OF RAMUCIRUMAB AND ERLOTINIB

2021 ◽  
pp. 75-81
Author(s):  
SIVA MADHU CHAITANYA ◽  
SRINATH NISSANKARARAO ◽  
SATYA LAKSHMI GANDHAM
Keyword(s):  
Liquid Chromatography ◽  
Dosage Form ◽  
Ultra Performance Liquid Chromatography ◽  
Chromatography Method ◽  
Pharmaceutical Dosage Form ◽  
Stability Indicating ◽  
Chiralcel Od ◽  
Successful Separation ◽  
Liquid Chromatography Method ◽  
Fine Resolution

Objective: This investigation demonstrates a stability-indicating and reliable “normal phase ultra-performance liquid chromatography” method to simultaneously quantify Ramucirumab and Erlotinib in the pharmaceutical dosage form. Methods: Successful separation was accomplished using Chiralcel-OD-3 column (50 mm x 4.6 mm, 3 μm) with an isocratic type of elution using a mobile phase containing n-hexane+isopropyl alcohol+methanol (89:10:1), respectively with 1.0 ml/min flow rate. The wavelength sensor was attuned at 266 nm to quantify Ramucirumab and Erlotinib. Results: Erlotinib and Ramucirumab peaks were eluted with fine resolution at retention times 1.7807 min and 3.175 min, respectively. In the 10-150 μg/ml and 1-15 μg/ml concentration ranges for Erlotinib and Ramucirumab, the calibration graphs were linear, with regression coefficients of 0.99928 and 0.99976, respectively. The suggested ultra-performance liquid chromatography approach has been shown as sensitive, precise, robust, accurate, specific and stability indicating through the resolution of Erlotinib and Ramucirumab from its degradation-based compounds. Conclusion: The established ultra-performance liquid chromatography technique was effectively extended to the evaluation of Erlotinib and Ramucirumab in the pharmaceutical dosage form and the test results appeared satisfactory.

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