Validation and application of Vierordt's spectrophotometric method for simultaneous estimation of tamoxifen/coenzyme Q10 in their binary mixture and pharmaceutical dosage forms

For the sake of improving patient compliance and sustainability of chemotherapy healthcare system, both TC and CoQ10 were formulated as solid lipid nanoparticles (SLNs). The study was focused on establishing and validating a simple and reproducible spectrophotometric method for simultaneous determin...

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Main Authors: Eman S. El-Leithy, Rania S. Abdel-Rashid
Format: Article
Language:English
Published: Elsevier 2016-04-01
Series:Asian Journal of Pharmaceutical Sciences
Subjects:
Online Access:http://www.sciencedirect.com/science/article/pii/S1818087616000118
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author Eman S. El-Leithy
Rania S. Abdel-Rashid
author_facet Eman S. El-Leithy
Rania S. Abdel-Rashid
author_sort Eman S. El-Leithy
collection DOAJ
description For the sake of improving patient compliance and sustainability of chemotherapy healthcare system, both TC and CoQ10 were formulated as solid lipid nanoparticles (SLNs). The study was focused on establishing and validating a simple and reproducible spectrophotometric method for simultaneous determination of TC and CoQ10 in their binary mixture or pharmaceutical dosage forms. A new method based on simultaneous estimation of drug mixture without prior separation was developed. Validation parameters were checked with International Conference on Harmonization (ICH) guidelines. The accuracy and reproducibility of proposed method was statistically compared to HPLC. The TC and CoQ10 were quantified at absorptivity wavelengths of 236 nm and 275 nm, respectively. Calibration curves obeyed Beer's law in range of 2–14 µg/ml with a correlation coefficient (R2) of 0.999 in both methanol and simplified simulated intestinal fluid (SSIF). The %means recovery of TC and CoQ10 in pure state or binary mixture at various concentration levels were all around 100%. The low values of SD and %RSD (<2%) confirm high precision and accuracy of the proposed method. Formulated SLNs showed different %means recovery in range 81–92% for TC and 32–59% for CoQ10. The data obtained by applying simultaneous Vierordt's equations showed no statistical significance in comparison to HPLC. Vierordt's method was successfully applied as a simple, accurate, precise, and economical analysis method for estimating TC and CoQ10 concentrations in pure state, binary mixture and pharmaceutical dosage forms.
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spelling doaj.art-dc205286543545279bdf092b93475c9a2022-12-22T03:10:01ZengElsevierAsian Journal of Pharmaceutical Sciences1818-08762016-04-0111231832510.1016/j.ajps.2016.02.005Validation and application of Vierordt's spectrophotometric method for simultaneous estimation of tamoxifen/coenzyme Q10 in their binary mixture and pharmaceutical dosage formsEman S. El-LeithyRania S. Abdel-RashidFor the sake of improving patient compliance and sustainability of chemotherapy healthcare system, both TC and CoQ10 were formulated as solid lipid nanoparticles (SLNs). The study was focused on establishing and validating a simple and reproducible spectrophotometric method for simultaneous determination of TC and CoQ10 in their binary mixture or pharmaceutical dosage forms. A new method based on simultaneous estimation of drug mixture without prior separation was developed. Validation parameters were checked with International Conference on Harmonization (ICH) guidelines. The accuracy and reproducibility of proposed method was statistically compared to HPLC. The TC and CoQ10 were quantified at absorptivity wavelengths of 236 nm and 275 nm, respectively. Calibration curves obeyed Beer's law in range of 2–14 µg/ml with a correlation coefficient (R2) of 0.999 in both methanol and simplified simulated intestinal fluid (SSIF). The %means recovery of TC and CoQ10 in pure state or binary mixture at various concentration levels were all around 100%. The low values of SD and %RSD (<2%) confirm high precision and accuracy of the proposed method. Formulated SLNs showed different %means recovery in range 81–92% for TC and 32–59% for CoQ10. The data obtained by applying simultaneous Vierordt's equations showed no statistical significance in comparison to HPLC. Vierordt's method was successfully applied as a simple, accurate, precise, and economical analysis method for estimating TC and CoQ10 concentrations in pure state, binary mixture and pharmaceutical dosage forms.http://www.sciencedirect.com/science/article/pii/S1818087616000118Tamoxifen citrateCoenzyme Q10Binary mixtureSolid lipid nanoparticlesValidation
spellingShingle Eman S. El-Leithy
Rania S. Abdel-Rashid
Validation and application of Vierordt's spectrophotometric method for simultaneous estimation of tamoxifen/coenzyme Q10 in their binary mixture and pharmaceutical dosage forms
Asian Journal of Pharmaceutical Sciences
Tamoxifen citrate
Coenzyme Q10
Binary mixture
Solid lipid nanoparticles
Validation
title Validation and application of Vierordt's spectrophotometric method for simultaneous estimation of tamoxifen/coenzyme Q10 in their binary mixture and pharmaceutical dosage forms
title_full Validation and application of Vierordt's spectrophotometric method for simultaneous estimation of tamoxifen/coenzyme Q10 in their binary mixture and pharmaceutical dosage forms
title_fullStr Validation and application of Vierordt's spectrophotometric method for simultaneous estimation of tamoxifen/coenzyme Q10 in their binary mixture and pharmaceutical dosage forms
title_full_unstemmed Validation and application of Vierordt's spectrophotometric method for simultaneous estimation of tamoxifen/coenzyme Q10 in their binary mixture and pharmaceutical dosage forms
title_short Validation and application of Vierordt's spectrophotometric method for simultaneous estimation of tamoxifen/coenzyme Q10 in their binary mixture and pharmaceutical dosage forms
title_sort validation and application of vierordt s spectrophotometric method for simultaneous estimation of tamoxifen coenzyme q10 in their binary mixture and pharmaceutical dosage forms
topic Tamoxifen citrate
Coenzyme Q10
Binary mixture
Solid lipid nanoparticles
Validation
url http://www.sciencedirect.com/science/article/pii/S1818087616000118
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