Abstract

A reliable RP-HPLC analytical method with UV detection at 421 nm was developed and validated for the quantitative determination of curcumin from rat plasma after oral administration of curcumin loaded nanocochleates (CU-NC) to rats. The chromatographic separation was performed on HIQ SIL, C18 (250 mm × 4.6 mm) column using methanol and water (80:20 v/v) as mobile phase, at 1.0 mL/min flow rate. Validation parameters included linearity, accuracy, precision, and limit of quantitation and detection. Good linearity was obtained over the range of 2.5-100 µg/mL (R2 = 0.9979) of curcumin. The developed HPLC method was precise, with <2% relative standard deviation. Accuracy, stability, and robustness studies were also found to be acceptable. Bland-Altman plot showed an acceptable repeatability coefficient. The method was under statistical control, revealed by a control chart. After CU-NC administration, pharmacokinetic parameters i.e. Cmax, AUC0-?, and AUMC0-?, were observed to be 97.69±10.84 µg/mL, 1402.77±9.67 (µg/mL)×h, and 35140.16±14.67 (µg/mL)×h2, respectively. This simple and precise method can be effectively implemented for routine analysis.

Highlights

  • Curcumin, a phytochemical isolated from Curcuma longa rhizomes, is widely recognized for its several health benefits including antitumor activity against different tumor cells.[1,2,3,4,5] Curcumin is regarded as safe and can be administered at high dosage

  • We prepared the curcumin loaded nanocochleates (CU–NC) using solvent evaporation technique to avoid the problems associated with curcumin absorption

  • Linearity To determine linearity, curcumin working standards prepared in the concentration range of 2.5–100 μg/mL were injected in triplicate to the HPLC system

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Summary

Introduction

A phytochemical isolated from Curcuma longa rhizomes, is widely recognized for its several health benefits including antitumor activity against different tumor cells.[1,2,3,4,5] Curcumin is regarded as safe and can be administered at high dosage. Despite its effectiveness and curative potential, the use of curcumin as an anticancer agent is restricted due to poor aqueous solubility, poor tissue absorption, rapid systemic clearance, faster metabolism, rapid degradation at neutral-alkaline pH, and impaired tumor targeting.[6,7,8] To override these drawbacks, different nanoparticulate drug delivery systems such as liposomes, solid lipid nanoparticles, nanostructured lipid carriers, polymeric nanoparticles, micelles, and nanoemulsions, have been investigated.[9] On the same ground, we prepared the curcumin loaded nanocochleates (CU–NC) using solvent evaporation technique to avoid the problems associated with curcumin absorption Such a formulation has not been reported earlier. Data obtained were processed using novel statistical techniques like Bland-Altman plot, capability analysis, and control chart

Material and Methods
2. HPLC Method Development
3. Analytical Method Validation
Normality of the Data and Outlier Detection
7. 2. Procedure
Results and Discussion
2. Extraction Method Optimization
3. Method Validation
Conclusion
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