scholarly journals UV Spectrophotometric Method Development and Validation for Determination of Cetilistat in API and in Pharmaceutical Dosage Form

2018 ◽  
Vol 7 (1) ◽  
pp. 1-8
Author(s):  
S. A. Kshirsagar ◽  
S. B. Mane ◽  
Y. S. Hanchate ◽  
A. S. Katte
Keyword(s):  
Spectrophotometric Method ◽  
Dosage Form ◽  
Method Development ◽  
Pharmaceutical Dosage Form ◽  
Method Development And Validation ◽  
Development And Validation

scholarly journals UV-SPECTROPHOTOMETRIC METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF IPRATROPIUM BROMIDE IN API AND PHARMACEUTICAL DOSAGE FORM

2020 ◽  
pp. 69-73
Author(s):  
ANJALI P. KOKANE ◽  
VARSHA S. TEGELI ◽  
BHAGYASHRI S. SHINDE
Keyword(s):  
Spectrophotometric Method ◽  
Dosage Form ◽  
Ipratropium Bromide ◽  
Method Development ◽  
Specific Method ◽  
Pharmaceutical Dosage Form ◽  
Ich Guidelines ◽  
Validation Parameters ◽  
Method Development And Validation ◽  
Development And Validation

Objective: The current work intended towards the developed and validated by using Simple, rapid, sensitive, precise and specific method UV Spectrophotometric method for the estimation of Ipratropium bromide in API and pharmaceutical formulation. Methods: Water used as a solvent and the absorbance of the drug was measured at the absorbance’s maxima of Ipratropium bromide λmax is 214 nm. Result: Calibration curve plotted in concentration range 20-120µg/ml exhibit the linearity relationship with line equation y=0.0062x+0.3161 and r2=0.995. The Accuracy was found to be 99.5-100.1%, the precision %RSD= 0.12888-0.30533, and the LOD and LOQ is 8.78266-28.5881. The method was found to comply with all the validation parameters as per ICH guidelines indicating the sensitivity of the method towards analyte. Conclusion: The method can be used satisfactory for the routine analysis of Ipratropium Bromide present in API and Pharmaceutical dosage form.

Simple and Sensitive Analytical Method Development and Validation of Nitazoxanide and Ofloxacin by RP- HPLC

2021 ◽  
pp. 84-86
Author(s):  
Abhishek Agrawal ◽  
Prem Kumar Bichala ◽  
Swapna Singh
Keyword(s):  
Dosage Form ◽  
Method Development ◽  
Hplc Method ◽  
Pharmaceutical Dosage Form ◽  
Quality Control Laboratory ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Method Development And Validation ◽  
Development And Validation

RP-HPLC method was developed for the determination for the validation of Nitazoxanide and Ofloxacin in pharmaceutical dosage form. Chromatographic separation was performed on Develosil ODS HG-5 RP C18, 15x4.6mm, 5µm column, with mobile phase comprising of mixture of ACN: Methanol: Citric acid in the ratio of 50:45:5 v/v, at the flow rate 1.0ml/min and the detection was carried out at 296nm. The comprehensive forced stress testing has been carried out as per USP guidelines. The drug Nitazoxanide is subjected to synthetic Benzamide, and the drug Ofloxacin is subject to synthetic Fluoroquinolone. RP- HPLC method was developed to separate analyte from all other degradation peaks. The method was successfully validated as per ICH guidelines for the purpose of conducting studies of the analyte in quality control laboratory. The drug was subjected to different degradation conditions; it was found to be stable in all degradation conditions. The purposed HPLC method was found to be precise, specific, accurate, rapid and economical for the determination of Nitazoxanide and Ofloxacin in pharmaceutical dosage form. The sample recoveries in all formulations were in good agreement with their respective label claims and this method can be used for routine analysis. The linearity range was found to be 0-50 (µg/ml) for Nitazoxanide and 0-50 (µg/ml) for Ofloxacin. Calibration curve was plotted and correlation co-efficient for the drugs found to be 0.999 and 0.997. Hence the results obtained were within the limits.

UV-SPECTROPHOTOMETRIC METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF SAXAGLIPTIN IN API AND PHARMACEUTICAL DOSAGE FORM

2020 ◽  
pp. 63-66
Author(s):  
BHAGYASHRI S. SHINDE ◽  
M. S. KALSHETTI ◽  
ANJALI P. KOKANE
Keyword(s):  
Spectrophotometric Method ◽  
Dosage Form ◽  
Method Development ◽  
Pharmaceutical Formulation ◽  
Pharmaceutical Dosage Form ◽  
Ich Guidelines ◽  
Recovery Study ◽  
Method Development And Validation ◽  
Curve Method ◽  
Development And Validation

Objective: A new sensitive, economical, simple, rapid UV spectrophotometric method has been developed for the estimation of Saxagliptin in API and pharmaceutical formulation. Methods: Calibration curve method was used for the estimation of Saxagliptin in API and pharmaceutical formulation. Results: The method was validated for linearity, range, accuracy, precision, robustness, LOD, LOQ. Linearity was found in the range of 10-60µg/ml. Accuracy was performed by using a recovery study. The amount of drug recovered was found to be in the range of 99.01-100.1%. All the parameters were validated as per the ICH guidelines. Conclusion: This method is suitable forused routine analysis of present Saxagliptin in API and Pharmaceutical dosage form.

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