Developed and validated stability indicating HPLC method for the determination of epirubicin in bulk drug, marketed injection and polymeric nanoparticles

Abstract

Present work is aimed to develop a simple, sensitive, robust and reliable HPLC method for routine quality control of epirubicin (EPI) in bulk drug, marketed injections and polymeric nanoparticles. Separation was carried out by C18 column. Isocratic elution was carried out using mobile phase A: 0.16% o-phosphoric acid solution, B: acetonitrile and methanol mixture (80:20, v/v) in the ratio of 60:40 (A: B) while the flow rate was maintained at 1mL/min. Analyses were performed at 233.5 nm using PDA detector. Excellent linear relationship was observed between peak-area versus drug concentration in the range of 1.0-100.0 μg/mL (r 2 , 0.999). Developed method was found to be sensitive (Limits of detection and quantification were found to be ~8 ng/mL and ~25 ng/mL, respectively), precise (RSD <1.0%, for repeatability and <2.0% for intermediate precision, within acceptable ranges of precision), accurate (recovery in different dosage form, 94.65 -100.26%, within acceptable range, 80-120%), specific and robust (% RSD <2, for system suitability parameters). Stress-induced degradation studies demonstrated that method can suitability be applied in the presence of degradants. Developed method has been successfully applied for the determination of entrapment efficiency, drug loading, in vitro release profile, in vitro permeation studies as well as stability assessment of polymeric nanoparticles.

Poloxamer/sodium cholate co-formulation for micellar encapsulation of doxorubicin with high efficiency for intracellular delivery: An in-vitro bioavailability study

“…A DL% of 0.26±0.14 % was obtained, values not far from those reported in the literature for polymeric micelles made of poly-lactide-co-glycolic acid and the anthracycline epirubicin. [30] To compare the in-vitro results obtained with DX and DX-PMs, water solutions of free and encapsulated drug having the same absorbance at 518 nm were prepared and then suitably diluted as described in the Materials and Methods section.…”

A Turn-ON fluorometric biosensor based on ssDNA immobilized with a metal phenolic nanomaterial for the sequential detection of Pb(ii) and epirubicin cancer drug

“…Several analytical methods, including atomic absorption spectroscopy, high-performance liquid chromatography (HPLC), electrochemical sensors, cold vapor atomic absorption spectroscopy, and inductively coupled plasma mass spectrometry, have been used for Pb 2+ and Epn drug analysis in the laboratory. [6][7][8][9][10][11] These described techniques oen rely on costly instruments, are time-consuming and operationally tedious, and involve sample pretreatment processes; therefore, it is essential to establish appropriate methodology to overcome these disadvantages. The use of uorescent biosensors is one of the best analytical tools compared with other techniques, as it involves very high intrinsic sensitivity, rapid analysis times, and simplicity.…”

Sensitive and Selective Electrochemical Detection of Epirubicin as Anticancer Drug Based on Nickel Ferrite Decorated with Gold Nanoparticles

“…EPR analysis has used a variety of analytical methods, including ultraviolet-visible spectroscopy (UV-Vis) [5,6], high-performance liquid chromatography (HPLC) [7][8][9][10][11], fluorimetry [12,13], mass spectrometry [14] and liquid chromatography-mass spectrometry/mass-spectrometry (LC-MS/MS) [15]. However, most of these techniques have drawbacks, such as long response times, complex analysis, high prices and limited sensitivity [16,17].…”

“…Due to their unique electrical, chemical and catalytic characteristics, various-shaped gold nanoparticles (Au NPs) such as nanospheres, nanorods and nanowires are widely utilized to construct electrochemical electrodes [45,46]. In addition, AuNPs have several benefits, including flexibility in size and shape management and ex- EPR analysis has used a variety of analytical methods, including ultraviolet-visible spectroscopy (UV-Vis) [5,6], high-performance liquid chromatography (HPLC) [7][8][9][10][11], fluorimetry [12,13], mass spectrometry [14] and liquid chromatography-mass spectrometry/massspectrometry (LC-MS/MS) [15]. However, most of these techniques have drawbacks, such as long response times, complex analysis, high prices and limited sensitivity [16,17].…”