DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-UPLC METHOD FOR THE QUANTIFICATION OF BALOXAVIR MARBOXIL IN TABLET FORMULATION

2020 ◽  
pp. 94-99
Author(s):  
T. VENKATA RAVEENDRANATH ◽  
R. T. SARAVANAKUMAR ◽  
C. H. K. V. L. S. N. ANJANA
Keyword(s):  
Retention Time ◽  
Orthophosphoric Acid ◽  
Regression Equation ◽  
Mobile Phase Composition ◽  
Stability Indicating ◽  
Stability Indicating Method ◽  
Development And Validation ◽  
Tablet Dosage ◽  
Chromatographic Elution ◽  
Quality Control Test

Objective: Aim of the present work is to develop a simple, accurate and precise stability-indicating method for the quantification of baloxavir marboxil (BLMX) in tablet dosage form by UPLC. Methods: Chromatographic elution was processed through a HSS C18 (100 x 2.1 mm, 1.8 mm) reverse phase column and the mobile phase composition of buffer 0.1% orthophosphoric acid and acetonitrile in the ratio of 50:50 was processed through a column at a flow rate of 0.3 ml/min. Column oven temperature was maintained at 30 °C and the detection wavelength was processed at 240 nm. Results: Retention time of BLMX was found to be 0.87 min. Repeatability of the method was determined in the form of %RSD and the value was 0.2. The percentage mean recovery of the method was found to be 99.47%. LOD, LOQ values obtained from the regression equation of BLMX were 0.69 and 2.10 mg/ml, respectively. Regression equation and correlation coefficient values of BLMX were y = 16994x+7179.2 and 0.9996. Drug was subjected for acid, peroxide, photolytic, alkali, neutral and thermal degradation studies and the results shown that the percentage of degradation was found between 5.96% and 9.55%. Conclusion: Retention time and total run time of the drug was 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 BLMX.

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. 

Development and Validation of Stability-indicating Reverse Phase HPLC Assay for Tramadol in Bulk and Tablet Formulations

2019 ◽  
Vol 12 (3) ◽  
pp. 4544-4552
Author(s):  
Pankaj Padmakar Nerkar ◽  
Vaishali Badjuar ◽  
Pradyum Ige ◽  
Hitendra Mahajan ◽  
Sameer Ansari
Keyword(s):  
Orthophosphoric Acid ◽  
Correlation Coefficients ◽  
Reversed Phase ◽  
Hplc Method ◽  
Reverse Phase Hplc ◽  
Stability Indicating ◽  
Stability Indicating Method ◽  
Ich Guidelines ◽  
Tablet Formulations ◽  
Development And Validation

This manuscript describes the development and validation of a simple, isocratic, and accurate reversed-phase HPLC method for the assay of tramadol in bulk powder form and tablet formulations. The chromato-graphic separation was achieved on an Qualisil BDS C18 (250 mm x 4.6mm, 5μm) column using acetonitrile: methanol: phosphate buffer pH 3.4 adjusted with orthophosphoric acid: (20:10:70, v/v) as a mobile phase, at a flow rate of 1 mL/min and detection at 271 nm. The linear range for tramadol were 2.0 to 10 μg/mL was obtained with correlation coefficients ≥ 0.999. The retention time was found to be 4.47 min for tramadol that was subjected to stress conditions, such as hydrolysis, oxidation, photolysis and thermal degradation, and the stressed samples were analyzed using the above methodology. The method was validated for the precision, accuracy, linearity and robustness. The developed stability-indicating method for tramadol was validated as per ICH guidelines.

scholarly journals DEVELOPMENT AND VALIDATION OF STABILITY INDICATING METHOD RP-HPLC METHOD OF ACOTIAMIDE

2018 ◽  
Vol 10 (9) ◽  
pp. 1 ◽  
Author(s):  
Charu P. Pandya ◽  
Sadhana J. Rajput
Keyword(s):  
Limit Of Detection ◽  
Hplc Method ◽  
Limit Of Quantification ◽  
Stability Indicating ◽  
Stability Indicating Method ◽  
Rp Hplc ◽  
Acid And Base ◽  
Stress Degradation ◽  
Development And Validation ◽  
Tablet Dosage

Objective: The objective of present work was to develop and validate simple, precise, accurate and specific stability indicating method for determination of acotiamide in presence of its degradation products.Methods: An isocratic RP-HPLC method has been developed using C-8 Thermo Hypersil BDS Column (250 x 4.6 mm i.d., 5µparticle size) with the mobile phase composition of acetonitrile: 0.1 % triethylamine in 0.2% formic acid (30: 70) at column oven temperature of 40 °C. The flow rate was 1.0 ml min-1 and effluent was detected at 282 nm. The method was validated in terms of linearity, accuracy, precision, LOD (Limit of Detection), LOQ (Limit of Quantification) and robustness as per ICH guidelines.Results: The method was found to be linear in the range of 10-60µg/ml. Limit of detection and limit of quantification was found to 0.36µg/ml and 1.10 µg/ml.% Recovery was found to be in the range of 99.45%-99.75%and precision less than 2%. The developed method was successfully applied for estimation of Acotiamide in marketed tablet formulation and percentage assay was found to be 100.45%. Acotiamide was subjected to stress degradation under acid, base, neutral hydrolysis, oxidation, dry heat, photolysis conditions. Significant degradation was observed in acid and base degradation.Conclusion: The developed RP-HPLC method was simple, rapid, accurate, precise and stability indicating for the estimation of Acotiamide in bulk and tablet dosage form.

Development and validation of a stability-indicating RP-HPLC method for simultaneous determination of dapagliflozin and saxagliptin in fixed-dose combination

2018 ◽  
Vol 42 (4) ◽  
pp. 2459-2466 ◽  
Author(s):  
N. Singh ◽  
P. Bansal ◽  
M. Maithani ◽  
Y. Chauhan
Keyword(s):  
Hplc Method ◽  
Fixed Dose ◽  
Simultaneous Estimation ◽  
Stability Indicating ◽  
Stability Indicating Method ◽  
Rp Hplc ◽  
Dose Combination ◽  
Development And Validation ◽  
Tablet Dosage

A simple and precise stability indicating method for the simultaneous estimation of dapagliflozin and saxagliptin in combined tablet dosage form was developed and validated using RP-HPLC.

scholarly journals STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF LEDIPASVIR AND SOFOSBUVIR IN BULK DRUG BY USING RP-HPLC

2020 ◽  
pp. 307-318
Author(s):  
RowthulaPrasanna Surya Bhavani RowthulaPrasanna Surya Bhavani ◽  
M.Sandhya Maduri M.Sandhya Maduri
Keyword(s):  
Method Development ◽  
Simultaneous Estimation ◽  
Stability Indicating ◽  
Stability Indicating Method ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Method Development And Validation ◽  
Bulk Drug ◽  
Development And Validation ◽  
Tablet Dosage

A new, simple, precise, accurate, and reproducible RP-HPLC for stability-indicating method development and validation of Ledipasvir and Sofosbuvir in bulk form. Separation ofLedipasvir and Sofosbuvir was successfully achieved Dona Zorbax C8, 250 X4.6mm, 5µm or equivalent in an isocratic mode utilizing 0.1% OPA: Methanol (45:55) at a flow rate of 1.0mL/min and the eluate was monitored at 238nm, with a retention time of 3.303 and 7.303minutes for Ledipasvir and Sofosbuvir respectively. The method was validated and their response was found to be linear in the drug concentration range of 45µg/ml to135 µg/ml for Ledipasvirand 200µg/ml to 600 µg/ml for and Sofosbuvir. The values of the correlation coefficient were found to 0.999 for Ledipasvirand 1 for Sofosbuvir respectively. The LOQ for Ledipasvirwere found to be  0.695 respectively. The LOQ for Sofosbuvir was found to be 2.2063 respectively. This method was found to be a good percentage recovery for Ledipasvir and Sofosbuvirwere found to be 100 and 100 respectively indicates that the proposed method is highly accurate. The specificity of the method shows a good correlation between retention times of standard with the sample so, the method specifically determines the analyte in the sample without interference from the excipients of tablet dosage forms. The method was extensively validated according to ICH guidelines for Linearity, Accuracy, Precession, Specificity, and Robustness.

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 Stability indicating method development and validation for the determination of haloperidol and benzhexol by RP-HPLC

2019 ◽  
Vol 1 (2) ◽  
pp. 52-58 ◽  
Author(s):  
M. Syamala ◽  
S Angalaparameswari ◽  
T. VimalakKannan ◽  
C. Sumanjali ◽  
T. Jyotshna
Keyword(s):  
Method Development ◽  
Simultaneous Estimation ◽  
Regression Equations ◽  
Stability Indicating Method ◽  
Rp Hplc ◽  
Method Development And Validation ◽  
Development And Validation ◽  
Tablet Dosage ◽  
Quality Control Test

A simple, Accurate, precise method was developed for the simultaneous estimation of the Haloperidol and Benzhexol in Tablet dosage form. The chromatogram was run through Kromasil (250mm 4.6mm, 5µ). Mobile phase containing Buffer and Acetonitrile and methanol in the ratio of 48:52 was pumped through column at a flow rate of 1.0 ml/min. The temperature was maintained at 30°C. The optimized wavelength for Haloperidol and Benzhexol was 220nm. The retention time of Haloperidol and Benzhexol were found to be 2.415 min and 2.820min. %RSD of the Haloperidol and Benzhexol were and found to be 0.6 and 0.2 respectively. %Recover was Obtained as 98.92% and 99.60% for Haloperidol and Benzhexol. LOD, LOQ values were obtained from regression equations of Haloperidol and Benzhexol were 0.42ppm, 1.27ppm and 0.04ppm, 0.14ppm respectively. Regression equation of Haloperidol is y = 24009x + 38704, and of Benzhexol is y = 40558x + 2880. Retention times are 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

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