scholarly journals A VALIDATED STABILITY INDICATING UV-SPECTROPHOTOMETRIC SIMULTANEOUS ESTIMATION OF ROSUVASTATIN CALCIUM AND FENOFIBRATE IN BULK AND PHARMACEUTICAL FORMULATION

2021 ◽  
Author(s):  
APEKSHA FUNDE ◽  
JAYSHREE KOKAT
Keyword(s):  
Pharmaceutical Formulation ◽  
Ratio Method ◽  
Simultaneous Estimation ◽  
Forced Degradation ◽  
Stability Indicating ◽  
Stability Indicating Method ◽  
Absorbance Ratio ◽  
Development And Validation ◽  
Interday Precision ◽  
Rosuvastatin Calcium

Objective: The present work deals with the development and validation of the absorbance ratio method for the estimation of rosuvastatin calcium and fenofibrate in bulk and pharmaceutical formulation. Studied forced degradation characteristics of bulk and pharmaceutical formulation as per stability guidelines. Methods: The bulk and pharmaceutical formulation studied by the absorbance ratio method. It is the ratio of absorbances at two selected wavelengths. One wavelength is the isoabsorptive point and another wavelength is λ max of one of the components. From the overlay spectra of the two drugs, ROS and FEN showed the isoabsorptive point at 249.5 nm. The second wavelength used was 287 nm, which was the λ max of FEN. Results: The drugs obeyed Beer's law and showed a good correlation. The correlation coefficient for the ROS was 0.999 and for FEN 0.999. The RSD for intraday precision was 0.57 for ROS and 0.057 for FEN. The interday precision was 0.05 for ROS and 0.03for FEN, respectively. The detection limit and quantification limit were found to be 0.048 and 0.14 μg/ml for ROS and 0.069 and 0.21μg/ml for FEN, respectively. More degradation was found in acid hydrolysis and photostability degradation. Conclusion: A simple, precise, accurate, validated, stability-indicating method for simultaneous estimation of rosuvastatin calcium and fenofibrate in bulk and pharmaceutical formulation has been developed.

scholarly journals Stability indicating method development and validation for simultaneous estimation of atorvastatin calcium and celecoxib in bulk and niosomal formulation by RP-HPLC

2015 ◽  
Vol 51 (3) ◽  
pp. 653-661 ◽  
Author(s):  
Priyanka S. Jadhav ◽  
Priti M. Jamkar ◽  
Amelia M. Avachat
Keyword(s):  
High Performance ◽  
Method Development ◽  
High Performance Liquid Chromatographic ◽  
Simultaneous Estimation ◽  
Atorvastatin Calcium ◽  
Stability Indicating ◽  
Stability Indicating Method ◽  
Bulk Drug ◽  
Development And Validation ◽  
Liquid Chromatographic

The present work describes development and validation of a specific, sensitive, precise and stability-indicating high-performance liquid chromatographic method of analysis of atorvastatin calcium and celecoxib, both as a bulk drug and in niosomal formulation. The analysis has been performed by using Cosmosil-C18 column (4.6 mm´250 mm, 5 m) at 25 °C using acetonitrile: ammonium acetate buffer pH 5.0: methanol (50:25:25 v/v/v) as mobile phase. The detection was carried out at 277nm with a flow rate of 1.0mL/min. The retention times of Atorvastatin calcium and Celecoxib were 6.195 and 3.989min, respectively. The method was validated according to ICH guidelines, for specificity, precision, linearity, accuracy and robustness. Atorvastatin calcium and Celecoxib were subjected to stress conditions of hydrolysis, oxidation, photolysis and thermal degradation. The degradation was observed in oxidation and acid hydrolysis. The linearity for atorvastatin calcium and celecoxib were in the range of 100-500 µg/mL. The recovery study of atorvastatin and celecoxib were found to be in the range of 98.96 - 99.92% and 98.90-100%, respectively. The proposed method was validated and successfully applied to the estimation of Atorvastatin calcium and Celecoxib in combined in-house niosomal formulation.

scholarly journals DEVELOPMENT AND VALIDATION OF STABILITY INDICATING CHROMATOGRAPHIC METHOD FOR SIMULTANEOUS ESTIMATION OF SACUBITRIL AND VALSARTAN IN PHARMACEUTICAL DOSAGE FORM

2017 ◽  
Vol 9 (5) ◽  
pp. 1
Author(s):  
Shweta Mishra ◽  
C. J. Patel ◽  
M. M. Patel
Keyword(s):  
Dosage Form ◽  
Degradation Products ◽  
Potassium Phosphate ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Forced Degradation ◽  
Pharmaceutical Dosage Form ◽  
Stability Indicating ◽  
Development And Validation ◽  
Tablet Dosage

Objective: This study aims to develop and validate a stability indicating HPLC method for simultaneous estimation of sacubitril and valsartan in pharmaceutical dosage form.Methods: Sacubitril and valsartan separation were achieved by LC-20 AT C18 (250 mm x 4.6 mm) column and buffer (potassium phosphate, pH 3.0): methanol (50:50) as mobile phase, at a flow rate of 1 ml/min (millilitre per minute). Detection was carried out at 224 nm (nanometer). The different HPLC experimental parameters were optimized and the method was validated according to the standard guideline. Forced degradation experiments were carried out by exposing sacubitril and valsartan standard and sample for thermal, photolytic, oxidative and acid-base hydrolytic stress conditions.Results: Retention time of sacubitril and valsartan were found to be 4.170 min (minute) and 6.530 min (minute) respectively. The method has been validated for linearity, accuracy, precision, LOD, and LOQ. Linearity observed for sacubitril is 12.25-36.75 μg/ml (microgram per milliliter) and for valsartan is 12.75-38.25 μg/ml (microgram per milliliter). The results showed that sacubitril and valsartan and the other degradation products were fully resolved and thus the proposed method is stability-indicating.Conclusion: The proposed HPLC method was found to be simple, specific, precise, accurate, rapid and economical for simultaneous estimation of valsartan and sacubitril in bulk and tablet dosage form. Thus the validated economical method was applied for forced degradation study of sacubitril and valsartan tablet.

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