A Rapid and Sensitive Bio Analytical RP-HPLC Method for Detection of Docetaxel: Development and Validation
Prachi Balaram Kharkar1, Swapnil Sunil Talkar1, Vandana Bharat Patravale1★★ Corresponding author
- 1Department of Pharmaceutical Sciences and Technology, Institute of Chemical Technology, Nathalal Parekh Marg, Matunga, Mumbai, INDIA.
CORRESPONDENCE
Vandana Bharat Patravale
Department of Pharmaceutical Sciences and Technology, Institute of Chemical Technology, Nathalal Parekh Marg, Matunga, Mumbai, INDIA.
Received: 22-08-2017; Revised: 17-09-2017; Accepted: 25-10-2017.
Volume 51, Issue 4S · pp. s729–s734 · PUBLISHED 2017 · DOI: 10.5530/ijper.51.4s.105
ABSTRACT
Objective: A rapid and selective high-performance liquid chromatographic (HPLC) method has been developed and validated for Docetaxel anhydrous (DTX) using Ketoconanzole (KCZ) as an internal standard in biological fluids. Methods: The analyte was extracted from human plasma by liquid-liquid extraction method using acetonitrile. The analysis was carried out on Licrosphere IV, C8 column (LC–GC Chromatography Solutions Pvt. Ltd, Mumbai, and India) (4.6×250 mm) with isocratic elution using a mobile phase composition of 0.2% triethylamine (pH 6.4 with orthophosphoric acid) (45%) and Acetonitrile (55%). The flow rate was 1.5ml/min with absorbance wavelength of 230 nm. Results: The developed method was found to be linear over the range of 100- 2500 ng/mL with correlation coefficients of about 0.999. The limit of quantification for docetaxel was found to be 100 ng/mL. The limit of detection was found to be 50 ng/ mL. The intra- and inter-day precision was determined to be <5% and the accuracy was 99–105%. The overall recovery for docetaxel was about 89.0% -91.0%. The total analysis time was only 10.0 min. The method was successfully applied for determination of DTX in rat plasma, to establish the pharmacokinetic profile of a marketed formulation. Conclusion: A simple, sensitive, rapid, accurate and prudent RP-HPLC method was developed, validated and applied for the Docetaxel anhydrous.
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Kharkar, P. B., Talkar, S. S., & Patravale, V. B. (2017). A Rapid and Sensitive Bio Analytical RP-HPLC Method for Detection of Docetaxel: Development and Validation. Indian Journal of Pharmaceutical Education and Research, 51(4S), s729–s734. https://doi.org/10.5530/ijper.51.4s.105