Comparative Study of First-Derivative Spectrophotometry and High Performance Liquid Chromatography Methods for Quantification of Paclitaxel in Liposomal Formulation

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. ]]>

Paclitaxel-loaded folate-coated long circulating and pH-sensitive liposomes as a potential drug delivery system: A biodistribution study

“…The radiolabeled yields for 99m Tc-SpHL-DTPA-PTX and 99m Tc-SpHL-folate-DTPA-PTX were 98.4 ± 1.1%and 98.0 ± 1.0%, respectively. 99m TcO 2 produced in the reaction was removed by passing the system through sterile filters (pore diameter = 0.22 μm) since this radiocolloid remains in the filter while 99m TcO 4 − and the radiolabeled complexes are freely filtered [23,24]. 99m Tc-SpHL-DTPA-PTX and 99m Tc-SpHL-fo-late-DTPA-PTX showed high stability in saline and plasma, even after long periods (Fig.…”

“…The percentage of drug encapsulation of PTX in SpHL-DTPA-PTX or SpHL-DTPA-folate-PTX was determined by high performance liquid chromatography (HPLC) based on the determination of PTX concentration in the liposomes before (non-purified liposomes) and after centrifugation (purified liposomes) [24]. The liposomal vesicles were disrupted using isopropanol in a volume ratio of 1:10 and later diluted in a mixture of acetonitrile:water (55:45 v/v).…”

“…The radioactivity was determined by a gamma counter (Wallac Wizard 1470–020 Gamma Counter; PerkinElmer Inc., Waltham, Massachusetts, USA). The solution was purified from 99m TcO 2 using a 0.22 μm syringe filter, as previously described [23,24]. …”

Experimental design of a liposomal lipid system: A potential strategy for paclitaxel-based breast cancer treatment

“…The encapsulation percentage of PTX in liposomes was determined by an ultraviolet derivative spectrophotometric (UVDS) method, previously validated [23]. Spectrophotometric analyses were carried out on an Allcrom ® UV 6300 spectrophotometer, connected to the UV-vis Analyst ® software.…”

Characteristics, Properties and Analytical Methods of Paclitaxel: A Review

“…DS-UV provided and alternative method that is fast, simple and with low cost compared to HPLC-UV. [52] The analytical methods found in the literature for PTX quantification employing liquid chromatography(LC) usually employ reversed-phase C8 or C18 silica bounded columns. [53] The mobile phase generally consists of 50% or more organic solvents (v/v), with methanol (MeOH) or acetonitrile (ACN), which can be related with the stability of paclitaxel in nonaqueous solvents, since the compound can suffer degradation or epimerization in aqueous solution.…”