Tropical Journal of Pharmaceutical Research

Original Research Article | OPEN ACCESS

A new sensitive HPLC/UV method for simultaneous determination of paclitaxel, sorafenib and omeprazole in standard solutions and spiked plasma: Application to in-vitro and in-vivo evaluation of paclitaxel polymeric nanoformulations

Mirina Sakhi¹, Abad Khan¹ , Ismail Khan¹, Zafar Iqbal², Sumaira Irum Khan², Muzna Ali khattak², Fahim Ullah³, Akhtar Aman⁴, Mehboob Alam⁵

¹Department of Pharmacy, University of Swabi, Swabi-23561; ²Department of Pharmacy, University of Peshawar; ³Department of Pharmacy, City University of Science and Information Technology, Peshawar; ⁴Department of Pharmacy, Shaheed Benazir Bhutto University, Sheringal, Upper Dir District, Khyber Pakhtunkhwa; ⁵Department of Pharmacy, Capital University of Science and Information Technology, Islamabad, Pakistan.

For correspondence:- Abad Khan Email: drabadkhan@uoswabi.edu.pk Tel:+92938490236

Accepted: 31 August 2021 Published: 30 September 2021

Citation: Sakhi M, Khan A, Khan I, Iqbal Z, Khan SI, khattak MA, et al. A new sensitive HPLC/UV method for simultaneous determination of paclitaxel, sorafenib and omeprazole in standard solutions and spiked plasma: Application to in-vitro and in-vivo evaluation of paclitaxel polymeric nanoformulations. Trop J Pharm Res 2021; 20(9):1949-1959 doi: 10.4314/tjpr.v20i9.23

© 2021 The authors.
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Abstract

Purpose: To develop a simple, novel, sensitive and rapid reverse phase high performance liquid chromatographic method for simultaneous determination of paclitaxel, sorafenib and omeprazole in standard solutions and spiked human plasma and its application to the in-vitro and in-vivo evaluation of paclitaxel polymeric nanoparticle formulations.

Methods: The method was tested for the assessment of paclitaxel, omeprazole and sorafenib using tamoxifen citrate as internal standard. The analysis was performed at a wavelength of 235 nm using Thermo HS C18 column, 40 °C column oven temperature, acetonitrile and water (70:30 v/v, pH 3.37 adjusted with phosphoric acid) as a mobile phase and at a flow rate of 0.8 ml/min. All analytes were extracted by simple protein precipitation method using acetonitrile. The linearity was assessed in the concentration range of 1 - 2000 ng/mL for paclitaxel, omeprazole and sorafenib.

Results: The developed chromatographic method effectively separated omeprazole, paclitaxel, sorafenib and IS with retention time of 3.93, 5.18, 6.43 and 9.93 min, respectively. The chromatograms of the three target compounds and IS showed good resolution and peak separation. The LOD of the method was 1, 5 and. 5 ng/mL while the LOQ was 2, 7.5 and 10 ng/mL, for paclitaxel, sorafenib and omeprazole, respectively.

Conclusion: The proposed RP-HPLC–UV method for the assessment of paclitaxel, sorafenib and omeprazole in standard solutions and spiked plasma is simple, economical, sensitive and robust. The method is also suitable for the analysis of paclitaxel in nanoformulations and for its pharmacokinetic studies in an animal model.

Keywords: Paclitaxel, Sorafenib, Omeprazole, Tamoxifen citrate, RP-HPLC, Nanoformulations