A simple, rapid and sensitive RP-HPLC-UV method for the simultaneous determination of sorafenib & paclitaxel in plasma and pharmaceutical dosage forms: Application to pharmacokinetic study.
A simple, economical, fast, and sensitive RP-HPLC-UV method has been developed for the simultaneous quantification of Sorafenib and paclitaxel in biological samples and formulations using piroxicam as an internal standard. The experimental conditions were optimized and method was validated according to the standard guidelines. The separation of both the analytes and internal standard was achieved on Discovery HS C18 column (250mm×4.6mm, 5μm) using Acetonitrile and TFA (0.025%) in the ratio of (65:35V/V) as the mobile phase in isocratic mode at a flow rate of 1ml/min, with a wavelength of 245nm and at a column oven temperature of 25°Cin a short run time of 12min. The limits of detection (LLOD) were 5 and 10ng/ml while the limits of quantification (LLOQ) were 10 and 15ng/ml for sorafenib and paclitaxel, respectively. Sorafenib, paclitaxel and piroxicam (IS) were extracted from biological samples by applying acetonitrile as a precipitating and extraction solvent. The method is linear in the range of 15-20,000ng/ml for paclitaxel and 10-5000ng/ml for sorafenib, respectively. The method is sensitive and reliable by considering both of its intra-day and inter-day co-efficient of variance. The method was successfully applied for the quantification of the above mentioned drugs in plasma. The developed method will be applied towards sorafenib and paclitaxel pharmacokinetics studies in animal models.
Department of Pharmacy, University of Peshawar, Peshawar 25120, Pakistan.
Ismail
I
Khan
Department of Pharmacy, University of Peshawar, Peshawar 25120, Pakistan. Electronic address: zafar_iqbal@upesh.edu.pk.
Zafar
Z
Iqbal
Department of Pharmacy, University of Swabi, Peshawar 25120,Pakistan.
Abad
A
Khan
Department of Pharmacy, University of Peshawar, Peshawar 25120, Pakistan.
Muhammad
M
Hassan
Department of Pharmacy, University of Peshawar, Peshawar 25120, Pakistan.
Fazle
F
Nasir
National Institute of Lasers and Optronics, NILOR, Islamabad, Pakistan.
Abida
A
Raza
Department of Pharmacy, University of Swabi, Peshawar 25120,Pakistan.
Lateef
L
Ahmad
Department of Pharmacy, University of Abasyn, Peshawar 25120,Pakistan.
Amjad
A
Khan
Department of Pharmacy, University of Abasyn, Peshawar 25120,Pakistan.
Muhammad
M
Akhlaq Mughal
D000818:Animals; D002138:Calibration; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D056148:Chromatography, Reverse-Phase / Q000379:methods*; D004304:Dosage Forms; D009536:Niacinamide / Q000031:analogs & derivatives* / Q000097:blood / Q000737:chemistry / Q000493:pharmacokinetics; D017239:Paclitaxel / Q000097:blood* / Q000737:chemistry / Q000493:pharmacokinetics*; D010671:Phenylurea Compounds / Q000097:blood* / Q000737:chemistry / Q000493:pharmacokinetics*; D010894:Piroxicam / Q000097:blood / Q000737:chemistry; D011817:Rabbits; D015203:Reproducibility of Results; D000077157:Sorafenib; D014466:Ultraviolet Rays
D004304:Dosage Forms; D010671:Phenylurea Compounds; D010894:Piroxicam; D009536:Niacinamide; D000077157:Sorafenib; D017239:Paclitaxel
Biological samples; Paclitaxel; Pharmacokinetics; RP-HPLC; Sorafenib