Abstract
A simple and sensitive method using first-derivative ultraviolet spectrophotometry (DS-UV) was developed, validated, and compared to the high performance liquid chromatography (HPLC) method for quantification of paclitaxel (PTX) in a liposomal formulation. Different analytical performance parameters such as linearity, accuracy, precision, specificity, detection, and quantification limits were determined according to International Conference on Harmonization (ICH) guidelines. No interference from the lipid compounds was detected in the HPLC and the DS-UV methods at 246 nm. Linearity determined for paclitaxel concentrations ranging from 6.0 to 24.0 µg mL -1 presented a correlation coefficient higher than 0.999 for both methods. Relative standard deviation (RSD) values lower than 2% for intra- and inter-day precision data could be obtained. Accuracy mean values ranged from 98.9 to 102.0%. Robustness data showed that the PTX content was unaffected by the alteration proposed. Both methods were adequate to quantify the drug in the liposomal formulation. DS-UV proved to be rapid, accurate, selective, sensitive, and, therefore, an attractive tool for routine determination of PTX.
Highlights
Paclitaxel (PTX) is a highly effective antineoplastic agent derived from natural sources
The aim of the present study was to develop and validate an alternative analytical method, using DS-UV to quantify the PTX in a liposomal formulation and to compare the results obtained with high performance liquid chromatography (HPLC), previously reported as the reference method for PTX determination.[3,10,17]
The proposed method was validated for both techniques for selectivity, linearity, precision, accuracy, robustness, and limits of detection (LOD) and quantification (LOQ) according to the procedures described in the International Conference on Harmonization (ICH) guidelines Q2 (R1) for the validation of analytical methods.[18]
Summary
Paclitaxel (PTX) is a highly effective antineoplastic agent derived from natural sources. PTX covers a broad spectrum of antitumor activity and has been used to treat ovarian cancer, breast cancer, non-small cell lung cancer, head and neck tumors, Kaposi’s sarcoma, and urologic malignancies.[1] One of the main problems associated with this drug is its low solubility in water. The pharmaceutical product commercially available, Taxol®, consists of micellar dispersion of PTX in Cremophor EL® (polyethoxylated castor oil used as a solubilizing surfactant) and dehydrated ethanol (1:1 v/v). Taxol® therapy is associated with severe toxic side effects such as hypersensitivity reactions, nephrotoxicity, and neurotoxicity.[2,3] In addition, PTX upon dilution with aqueous media can result in the drug precipitation.[3,4] To overcome these disadvantages, efforts have been made to develop PTX delivery systems, including the use of liposomes.[5,6,7,8] Liposomes are currently being investigated to improve current cancer treatment regimens due to their capacity to increase the solubility of poorly water-soluble antitumor drugs
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