scholarly journals Development and Validation of a Stability-Indicating RP-HPLC Assay Method and Stress Degradation Studies on Dapiprazole

2012 ◽  
Vol 51 (9) ◽  
pp. 856-860 ◽  
Author(s):  
T. Ramesh ◽  
P. N. Rao
Keyword(s):  
Assay Method ◽  
Hplc Assay ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Stress Degradation ◽  
Degradation Studies ◽  
Development And Validation

scholarly journals STABILITY INDICATING RP-HPLC ASSAY METHOD FOR ESTIMATION OF MIDODRINE HYDROCHLORIDE IN BULK AND TABLETS

2016 ◽  
Vol 8 (9) ◽  
pp. 283 ◽  
Author(s):  
Hemant K. Jain ◽  
Kishor N. Gujar ◽  
Varsha A. Randhe
Keyword(s):  
High Performance ◽  
High Performance Liquid Chromatographic ◽  
Assay Method ◽  
Forced Degradation ◽  
Hplc Assay ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Forced Degradation Studies ◽  
Degradation Studies ◽  
The Stability

<p><strong>Objective: </strong>To develop an accurate, simple, sensitive and precise stability indicating reverse phase-high performance liquid chromatographic (RP-HPLC) assay method for estimation of Midodrine hydrochloride (MD) in bulk and tablets.</p><p><strong>Methods: </strong>The chromatographic separation was performed on enable C<sub>18</sub>, (250 mm X 4.6 mm, 5 μm) column. The mobile phase consists of triethylamine buffer 0.02%, pH-3: acetonitrile (38:62 v/v) was delivered at a flow rate of 0.6 ml/min and UV detection at 289 nm. The method was validated with forced degradation studies as per ICH guidelines.</p><p><strong>Results: </strong>The retention time of the drug was found to be 3.56 min. The developed method was found to be linear in a concentration range of 19.98-99.9μg/ml of the drug (r<sup>2</sup>= 0.9998). The low value of % RSD indicates reproducibility of the method. The low value of LOD and LOQ suggests the sensitivity of the method. The results of forced degradation studies indicated that the drug was stable in acidic condition and degraded in basic, oxidative and hydrolytic conditions.</p><strong>Conclusion: </strong>The present study represents first stability-indicating HPLC assay method that deals with the estimation of midodrine hydrochloride. It can be concluded from the results that the developed method is simple, rapid, accurate, specific, sensitive and precise. Thus, this method can be used for routine analysis of midodrine hydrochloride formulation and to check the stability of bulk samples.<p> </p>

scholarly journals STABILITY INDICATING RP-HPLC ASSAY METHOD FOR ESTIMATION OF DIMETHYL FUMARATE IN BULK AND CAPSULES

2017 ◽  
Vol 9 (5) ◽  
pp. 121 ◽  
Author(s):  
Hemant K. Jain ◽  
Archana A. Gunjal
Keyword(s):  
Dimethyl Fumarate ◽  
Hplc Method ◽  
Assay Method ◽  
Forced Degradation ◽  
Dihydrogen Phosphate ◽  
Column Temperature ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Forced Degradation Studies ◽  
Degradation Studies

Objective: To develop an accurate, simple, precise and specific stability indicating RP-HPLC method for estimation of dimethyl fumarate in bulk and capsules.Methods: An Inertsil ODS (150x4.6 mm, 5µ) column and a mobile phase containing acetonitrile: potassium dihydrogen phosphate buffer pH 6.8 (50:50% v/v) was used for this study. The flow rate was maintained at 1.0 ml/min; column temperature was fixed at 35 °C and UV detection was carried out at 210 nm. The forced degradation studies were performed and method was validated with as per ICH guidelines.Results: The retention time of dimethyl fumarate was found to be 3.3±0.02 min. The value of correlation coefficient between peak area and concentration was found to be 0.9993. The mean percent recovery of dimethyl fumarate in capsules was found in the range of 99.65 to 101.64%. The results of forced degradation studies indicated that the drug was found to be stable in basic, oxidative and thermal conditions while degraded in acidic conditions.Conclusion: It can be conducted from results that the developed HPLC method is simple, accurate, precise and specific. Results of stress testing study revealed that the method is stability indicating. Thus, this method can be used for routine analysis of dimethyl fumarate capsules and check their stability.  

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 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.

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