Development and Validation of Rapid and Simple Bioanalytical Method for Docetaxel with One Step Protein Precipitation
By: Mehendale, P. C
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Contributor(s): Athawale, R. B.
Publisher: Mumbai Indian Drug Manufacture's Association - IDMA 2019Edition: Vol. 56 (07).Description: 23-32.Subject(s): PHARMACEUTICSOnline resources: Click here
In:
Indian drugsSummary: Rapid and simple bio-analytical method with one step protein precipitation and extraction using acetonitrile as extraction solvent was developed for docetaxel. The extraction efficiency was 87.81% with satisfactory separation of docetaxel and IS peaks by isocratic elution with C18 column (25 cm X 4.5 mm, 0.5μm), acetonitrile and water (53:47 % V/V) as a mobile phase at ambient temperature and flow rate of 1mL/min. Paclitaxel solution in acetonitrile (10 mcg/ mL) was used as internal standard. The calibration curve was linear over the concentration range 50 – 5000 ng/mL, regression coefficient R2= 0.99936 and slope 0.00034. The limit of quantification and limit of detection were found to be 33 ng/ mL and 100 ng/mL, respectively. Coefficient of variation for within day and between the days was in the range of 10.9 to 14.9 and 12.5 to 15.05, respectively. Accuracy of the method indicated % recovery of 97.92 – 104.24%. Thus, a precise, accurate and robust method was developed and validated as per FDA guidelines.
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School of Pharmacy Archieval Section | Not for loan | 2018648 |
Rapid and simple bio-analytical method with one step protein precipitation and extraction using acetonitrile as extraction solvent was developed for docetaxel. The extraction efficiency was 87.81% with satisfactory separation of docetaxel and IS peaks by isocratic elution with C18 column (25 cm X 4.5 mm, 0.5μm), acetonitrile and water (53:47 % V/V) as a mobile phase at ambient temperature and flow rate of 1mL/min. Paclitaxel solution in acetonitrile (10 mcg/ mL) was used as internal standard. The calibration curve was linear over the concentration range 50 – 5000 ng/mL, regression coefficient R2= 0.99936 and slope 0.00034. The limit of quantification and limit of detection were found to be 33 ng/ mL and 100 ng/mL, respectively. Coefficient of variation for within day and between the days was in the range of 10.9 to 14.9 and 12.5 to 15.05, respectively. Accuracy of the method indicated % recovery of 97.92 – 104.24%. Thus, a precise, accurate and robust method was developed and validated as per FDA guidelines.
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