Affiliation:
1. Charotar University of Science and Technology, Ramanbhai Patel College of Pharmacy , Changa, Gujarat 388421 Anand, India
2. Kashiv Bioscience LLC, Analytical Research & Development , Ahmedabad, Gujarat 382210, India
Abstract
Abstract
Background
Camptothecin is a potent anticancer drug used for the treatment of various cancers.
Objective
The goal of this research investigation was to develop and validate a new stability-indicating HPLC technique for the quantitative assessment of camptothecin in in-house developed mesoporous silica nanoparticles, a novel nanoformulation matrix for the treatment of cancer.
Method
The Waters Inertsil® HPLC column (C18) was used for the chromatographic separation, with a flow rate of 1 mL/min, a column oven temperature of 40°C, an injection volume of 10 µL, a detection wavelength of 216 nm, and a 10 min runtime overall. An isocratic blend of phosphate buffer (10 mM, pH7.0) and acetonitrile (60:40, v/v) served as the mobile phase. Various stress conditions including acid, alkali, oxidative, photolytic, thermal, and humidity environments were tested for the quantitative estimation of the camptothecin through the proposed method.
Results
The results demonstrated that the proposed method is specific (peak purity ≥0.999), accurate (99.69–100.64% w/w), precise (RSD, % <2.0), and sensitive (LOD—0.17 µg and LOQ—0.56 µg) in accordance with ICH guideline Q2 (R1). Any unidentified degradation products did not interfere with the drug’s estimation. Furthermore, the current method of analysis has eliminated any excipient interference from the matrix effect caused by the numerous excipients of the formulation matrix.
Conclusions
To quantify camptothecin for routine assay purposes, this research work offers a novel and straightforward HPLC methodology with optimized chromatographic parameters, contributing to the research and development community while ensuring an appropriate and efficient use of the drug through a variety of nanoformulation for cancer treatment.
Highlights
The stability-indicating HPLC method was found to be specific and suitable for routine analysis of camptothecin. The absence of any interference from excipients was confirmed by forced degradation studies.
Funder
Charusat Seed Grant for Research
Charotar University of Science and Technology
Publisher
Oxford University Press (OUP)
Cited by
2 articles.
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