Development and validation of a liquid chromatography-ultraviolet absorbance detection assay using derivatisation for the novel marine anticancer agent ES-285·HCl [(2S,3R)-2-amino-3-octadecanol hydrochloride] and its pharmaceutical dosage form

2003 ◽  
Vol 1020 (2) ◽  
pp. 251-258 ◽  
Author(s):  
Monique W.J den Brok ◽  
Bastiaan Nuijen ◽  
Elena Miranda ◽  
Pablo Floriano ◽  
Simon Munt ◽  
...  
Keyword(s):  
Liquid Chromatography ◽  
Dosage Form ◽  
Anticancer Agent ◽  
The Novel ◽  
Pharmaceutical Dosage Form ◽  
Ultraviolet Absorbance ◽  
Absorbance Detection ◽  
Detection Assay ◽  
Development And Validation

scholarly journals DEVELOPMENT AND VALIDATION OF UV SPECTROPHOTOMETRICMETHOD FOR QUANTITATIVE ESTIMATION OF GLIPIZIDEIN PHARMACEUTICAL DOSAGE FORM

2020 ◽  
pp. 104-107
Author(s):  
ANUJA SURYAWANSHI ◽  
AFAQUEANSARI ◽  
MALLINATH KALSHETTI
Keyword(s):  
Dosage Form ◽  
Limit Of Detection ◽  
Quantitative Estimation ◽  
The Novel ◽  
Limit Of Quantification ◽  
Pharmaceutical Dosage Form ◽  
Novel Method ◽  
Bulk Drug ◽  
Development And Validation

Objective: The present work is aimed to develop a simple, rapid, selective and economical UV spectrophotometric method for quantitative determination of Glipizideinbulk and pharmaceutical dosage form. Methods: In this method Dimethyl Form amide (DMF) was used as solvent, the absorption maxima was found to be275 nm in DMF. The developed method was validated for linearity, accuracy, precision, ruggedness, robustness, LOD and LOQ in accordance with the requirements of ICH guideline. Results: The linearity was found to be 10-60 µg/ml having linear equation y=0.017x-0.006 with correlation coefficient of 0.997. The% recovery was found to be in the range of 98.7-100%. The % RSD for intra-day and inter-day precision was found to be 0.569923 and 0.40169 respectively. The limit of detection (LOD) and limit of quantification (LOQ) was found to be3.06 µg/ml and 9.27 µg/ml respectively. Conclusion: The developed method was validated as per ICH Q2(R1) guidelines. The novel method is applicable for the analysis of bulk drug in its pharmaceutical dosage form.

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