Methods (San Diego, Calif.) · 2026
Concurrent quantification of novel cyclometalated iridium-based photosensitizer and 5-fluorouracil using RP-HPLC: Applications in nanoformulation analysis, drug release, and skin permeation studies.
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Kumbhar Pragati Ramesh, Desai Vaibhavi Meghraj, Sumit Sumit, Chowdhury Rajdeep, Laskar Inamur Rahaman, Singhvi Gautam
Аннотация
BACKGROUND: Combination therapies for skin cancer are emerging as effective strategies to overcome limitations of monotherapies, such as limited efficacy, resistance development, and recurrence. Chemo-photodynamic therapy represents a promising approach for this. In this study, novel cyclometalated iridium-based photosensitizer was investigated in combination with 5-fluorouracil. As the photosensitizer is novel, no analytical method has been reported for its simultaneous estimation with 5-FU. Such a method is essential for quantifying both analytes in nanoformulations, enabling pharmacokinetic and skin permeation studies critical for development of chemo-photodynamic therapy.
METHOD: A simultaneous RP-HPLC method was developed using a C18-column with an isocratic mobile phase of acetonitrile and pH 4.0 buffer (80:20v/v) at a flow rate of 1.0 mL/min. Detection was performed at 265 nm. The method was validated in accordance with ICH guidelines, including forced-degradation studies, and applicability was evaluated using nanodispersion and skin permeation samples.
RESULTS: Good resolution was achieved between CIBP and 5-FU, with retention times of 5.944 and 2.714 min, respectively. The method showed excellent linearity (r2>0.999) at concentration range of 500-12,000 ng/mL. High accuracy was observed, with recoveries of 100.74-101.35% for CIBP and 100.94-101.05% for 5-FU. High sensitivity was demonstrated, with LOD/LOQ values of 6.89/20.90 ng/mL for CIBP and 5.62/17.04 ng/mL for 5-FU. Precision studies showed %RSD < 2% for both analytes.
CONCLUSION: The validated method is reliable, economical, and suitable for routine quantification of both analytes in stability studies, drug-encapsulation, in-vitro release, and ex-vivo skin permeation samples, supporting quality control and dermatokinetics profiling of dual-drug-loaded nanodispersion.
METHOD: A simultaneous RP-HPLC method was developed using a C18-column with an isocratic mobile phase of acetonitrile and pH 4.0 buffer (80:20v/v) at a flow rate of 1.0 mL/min. Detection was performed at 265 nm. The method was validated in accordance with ICH guidelines, including forced-degradation studies, and applicability was evaluated using nanodispersion and skin permeation samples.
RESULTS: Good resolution was achieved between CIBP and 5-FU, with retention times of 5.944 and 2.714 min, respectively. The method showed excellent linearity (r2>0.999) at concentration range of 500-12,000 ng/mL. High accuracy was observed, with recoveries of 100.74-101.35% for CIBP and 100.94-101.05% for 5-FU. High sensitivity was demonstrated, with LOD/LOQ values of 6.89/20.90 ng/mL for CIBP and 5.62/17.04 ng/mL for 5-FU. Precision studies showed %RSD < 2% for both analytes.
CONCLUSION: The validated method is reliable, economical, and suitable for routine quantification of both analytes in stability studies, drug-encapsulation, in-vitro release, and ex-vivo skin permeation samples, supporting quality control and dermatokinetics profiling of dual-drug-loaded nanodispersion.