A Rapid and Sensitive Bio Analytical RP-HPLC Method for Detection of Docetaxel: Development and Validation

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, C 8 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.

Docetaxel-Loaded Methoxy poly(ethylene glycol)-poly (L-lactic Acid) Nanoparticles for Breast Cancer: Synthesis, Characterization, Method Validation, and Cytotoxicity

“…Several previous reports claim to develop a rapid, sensitive, and reliable HPLC method for the detection of docetaxel (DTX) in biological matrices [36,37]. Attempts have also been made to develop and validate methods to detect DTX-loaded PLGA nanoparticles [38].…”

“…The quantitative determination of analytes and drug metabolites in the biological matrix plays an important role in the estimation and interpretation of bioavailability, bioequivalence, and pharmacological and pharmacokinetic profiles of a drug [36]. Data suggested that the specificity, accuracy, and precision followed ICH guidelines.…”

Development of Quantitative Method of Tulobuterol Hydrochloride in Rat Plasma: Validation and Application to Preclinical Pharmacokinetics

“…It was analyzed as the ratio of the peak area of extracted plasma samples as per sample preparation in three replicates to unextracted plasma-free samples in three replicates [23]. It was, analyzed by plasma concentrations of tulobuterol hydrochloride such as 150, 300, and 450 ng/ml at 50, 100, and 150 %.…”

Profiling Docetaxel in Plasma and Urine Samples from a Pediatric Cancer Patient Using Ultrasound-Assisted Dispersive Liquid–Liquid Microextraction Combined with LC–MS/MS

“…Since being approved for use in chemotherapy by the Food and Drug Administration (FDA) in 1996, researchers have developed numerous analytical methods to monitor DOC in various animal and human matrices, including blood and its fractions, saliva, urine, and feces [1]. While the majority of procedures for the analysis of DOC developed since 2010 have been based on liquid chromatography (LC) [12][13][14][15][16][17][18][19] and ultra-performance liquid chromatography (UPLC) [20], methods based on capillary electrophoresis (CE) [21] and immunoassays have also been reported [22]. In these works, the complex biological matrices containing DOC are subjected to sample preparation prior to instrumental analysis, mainly via classical extraction techniques such as liquid-liquid extraction (LLE) [12,13,19], protein precipitation (PPt) [14,15,23] and solid-phase extraction (SPE) [16][17][18]; however, to the best of our knowledge, microextraction techniques have yet to be applied to isolate DOC from biological matrices.…”

“…While the majority of procedures for the analysis of DOC developed since 2010 have been based on liquid chromatography (LC) [12][13][14][15][16][17][18][19] and ultra-performance liquid chromatography (UPLC) [20], methods based on capillary electrophoresis (CE) [21] and immunoassays have also been reported [22]. In these works, the complex biological matrices containing DOC are subjected to sample preparation prior to instrumental analysis, mainly via classical extraction techniques such as liquid-liquid extraction (LLE) [12,13,19], protein precipitation (PPt) [14,15,23] and solid-phase extraction (SPE) [16][17][18]; however, to the best of our knowledge, microextraction techniques have yet to be applied to isolate DOC from biological matrices. This gap in the literature is notable, as microextraction techniques use significantly less hazardous chemicals, thus aligning them with the principles of green chemistry.…”