Stability Indicating Forced Degradation Studies

2019 ◽  
Vol 12 (1) ◽  
pp. 429
Author(s):  
Shubhangi V. Sutar ◽  
Veerendra. C. Yeligar ◽  
Shitalkumar S. Patil
Keyword(s):  
Forced Degradation ◽  
Stability Indicating ◽  
Forced Degradation Studies ◽  
Degradation Studies

scholarly journals Stability indicating thin-layer chromatographic method for estimation of antidiabetic drug Remogliflozin etabonate

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Dimal A. Shah ◽  
Ishita I. Gondalia ◽  
Vandana B. Patel ◽  
Ashok Mahajan ◽  
Usmangani Chhalotiya ◽  
...  
Keyword(s):  
Thin Layer ◽  
High Performance ◽  
Chromatographic Method ◽  
Tablet Formulation ◽  
Base Hydrolysis ◽  
Forced Degradation ◽  
Stability Indicating ◽  
Forced Degradation Studies ◽  
Degradation Studies ◽  
Remogliflozin Etabonate

Abstract Background A sensitive, precise, and stability-indicating high-performance thin-layer chromatographic (HPTLC) method has been developed for the analysis of Remogliflozin etabonate in tablet formulation. HPTLC plates precoated with silica gel 60 F254 were used as the stationary phase; methanol: ethyl acetate: toluene: NH3 (2:4:4:0.1, v/v/v) was used as mobile phase, and densitometry was used for the quantitative estimation of the drug. The proposed method was validated with respect to linearity, accuracy, precision, and robustness and applied for the estimation of drug in tablet dosage form. Results The Rf value of Remogliflozin etabonate was observed to be 0.61. The densitometric estimation was performed in reflectance mode at 229 nm. The method was found to be linear in the range of 500–8000 ng/band for Remogliflozin etabonate. The possible degradation pathway was estimated by performing forced degradation studies. The degradant peaks were well resolved from the drug peak with acceptable resolution in their Rf value. Conclusion An accurate and precise high-performance thin-layer chromatographic method has been developed for the quantification of Remogliflozin etabonate in tablets. Forced degradation studies were performed, and drug was found to be highly susceptible to acid, base hydrolysis, and oxidative stress degradation and gets converted into active drug Remogliflozin. Both Remogliflozin etabonate and Remogliflozin bands were well resolved. The method was applied for the analysis of drug in tablet formulation, and it can be used for routine quality control analysis, as well as for the analysis of stability samples.

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 OF FORCED DEGRADATION STUDIES OF FAVIPIRAVIR BY RP-HPLC

2021 ◽  
Vol 10 (6) ◽  
pp. 3823-3826
Author(s):  
, Shyamala
Keyword(s):  
Mobile Phase ◽  
High Performance ◽  
Ultra Violet ◽  
Active Pharmaceutical Ingredient ◽  
Spectral Studies ◽  
Forced Degradation ◽  
Stability Indicating ◽  
Stability Indicating Method ◽  
Forced Degradation Studies ◽  
Degradation Studies

Forced degradation studies and stability indicating method were developed for the estimation of Favipiravir by reverse phase High performance liquid chromatography in active Pharmaceutical ingredient and its tablet dosage form. The method was achieved by using C18 column (250 X 4.6mm X 4µm) with mobile phase mixture ortho phosphoric acid and acetonitrile in the ratio 60:40. The mobile phase was allowed to pump with the flow rate 1ml/min by maintaining detection wavelength at 324nm using ultra-violet detector. Favipiravir drug was subjected to various stress conditions according to International Conference of Harmonization Q1A(R2) guidelines to establish stability indicating method. Favipiravir drug was found to be sensitive at peroxide degradation. The impurity peak was characterized by mass spectral studies. The method was validated for analytical standards such as linearity, accuracy, Precision, sensitivity and robustness. A rapid and sensitive method was developed for the estimation of favipiravir which indicates its stability indicating behavior.

scholarly journals Analysis of Chromium (III)Picolinate in Capsule dosage form by using Stability indicating HPTLC Method

2019 ◽  
Vol 12 (6) ◽  
pp. 101-108
Author(s):  
Aditi R. Kakade ◽  
Savita Yadav
Keyword(s):  
Nutritional Supplement ◽  
Chromium Picolinate ◽  
Forced Degradation ◽  
Capsule Formulation ◽  
Stability Indicating ◽  
Ich Guidelines ◽  
Forced Degradation Studies ◽  
Method Optimization ◽  
Degradation Studies ◽  
Hptlc Method

Chromium (III) picolinate is used as a nutritional supplement and has been valuable effects on carbohydrate and lipid metabolism alleviating symptoms associated with diabetes. A chromium supplement produces beneficial results in reducing insulin sulfonylurea or metformin requirements. Hence, stability indicating HPTLC method was developed for estimation of Chromium picolinate in capsule formulation. The development of HPTLC method optimization on precoated silica gel 60 F254 aluminium plates of 20 cm x 20 cm, 250μm thickness. The mobile phase used was methanol: ethyl acetate6:4 (v/v). The densitometry detection was done at 264 nm. Also, the forced degradation studies were performed and method was validated with as per ICH guidelines. The Rf value obtained was 0.39 ±0.05.Linearity data for the calibration curve gave a good linear relationship over the concentration range of 100-600ng/spot for Chromium picolinate (correlation coefficient R2 =0.9997). The percent recovery of Chromium picolinate in marketed formulation was found in the range of 99.56%.Force degradation and validation of method was done as per ICH guidelines and the results are within the compliance limit.The developed HPTLC method gave good results for force degradation studies show that the method is stability indicating. Thus, this method can be used for routine analysis of Chromium picolinate and can be use for its future usage

scholarly journals QUANTIFICATION OF ROPINIROLE HYDROCHLORIDE IN API AND TABLETS BY NOVEL STABILITY-INDICATING RP-HPLC METHOD: IT’S VALIDATION AND FORCED DEGRADATION STUDIES

2019 ◽  
pp. 293-298
Author(s):  
SADASHIVAIAH R. ◽  
Rohith G. ◽  
SATHEESHA BABU B. K.
Keyword(s):  
Retention Time ◽  
High Performance ◽  
Human Error ◽  
Hplc Method ◽  
Forced Degradation ◽  
Chromatography Method ◽  
Stability Indicating ◽  
Forced Degradation Studies ◽  
Ropinirole Hydrochloride ◽  
Degradation Studies

Objective: A simple, economical, robust and stability-indicating reverse phase high performance liquid chromatography method was developed and validated for the quantification of ropinirole hydrochloride in API and tablets to achieve shorter retention time, to minimize human error by avoiding the use of buffers and weighing procedure and analyze more number of samples in shorter period of time with good accuracy. Methods: The chromatographic conditions for separation of ropinirole hydrochloride was carried out using Gemini NX C18 column (15 cm x 4.6 mm), 5 µm particle size with the mobile phase composing of methanol: acetonitrile (70:30 v/v), delivered at flow rate 0.7 ml/min and UV detection wavelength at 250 nm. Results: The retention time was observed at 2.718 min. The system suitability results were found to be within limits. The method was precise, with lower than 2 %RSD and the calibration curve was linear (r2=1) over a concentration range of 2.5-160 µg/ml. The detection and quantification limit was found to be 0.045 µg/ml and 0.15 µg/ml, respectively. Recovery of the drug was found between 100.09-100.19%. The assay of ropinirole hydrochloride in ROPITOR® and ROPARK® tablets were found to be 100.4 and 103.60 %, respectively. The forced degradation studies were carried out to demonstrate the specificity of the method by exposing the API under conditions of hydrolysis, oxidation, thermal and photolytic as per ICH Q1A(R2) guidelines. Conclusion: The low coefficient of variation and agreeable recovery confirmed that the newly developed method could be employed for routine analysis of ropinirole hydrochloride in API and tablets.

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