Estimation of related substancesby usinghigh-performance liquid chromatographic method was developed and validated for the determination of Tigecycline in the present work. Reversedphase chromatography was performed on Waters 2489 UV 2695 pump, Waters 2998 PDA 2695 pump Software Empower 2 photodiode array detector using Zorbax Eclipse plus C18 (100 mm × 4.6 mm, 1.8 µm particle size) column with eluent-A: pH 6.50 buffer: acetonitrile: DMSO (90:5:5 %v/ v/v) and eluent-B: pH 6.50 buffer: acetonitrile: DMSO (71:24:5 %v/v/v) as mobile phase at a flow rate of 1.0 mL/min. with UV detection at 270 nm.Linearity was observed in the concentration range of Tigecycline LOQ-1.13% (R2 = 1.000), the concentration range of di-MA-TIG impurity 0.04-0.23% (R2 = 1.000), the concentration range of CMI 0.05-0.23% (R2 = 0.999). The limit of quantitation (LOQ) and limit of detection (LOD) were found to be di-MA-TIG impurity 0.0001 and 0.0004mg/ mL, CMI impurity 0.0001and 0.0004µg/mL, Tigecycline 0.0001and 0.0005mg/mL respectively. The method was validated as per ICH guidelines. The %RSD precision was found to be less than 1.0 %. The percentage recovery was in good agreement with the labeled amount in the pharmaceutical formulations and the method is simple, specific, precise and accurate for the determination of Tigecycline in pharmaceutical formulations.

The present paper describes the reverse phase-high performance liquid chromatographic method and was validated as per ICH guidelines for the determination of related substances in Cabazitaxel. RP-Liquid chromatography technique was performed with pH 3.0 phosphate buffer and acetonitrile as mobile phase at a flow rate of 0.8 mL/min. on Waters 2489 UV 2695 pump, Waters 2998 PDA 2695 pump Software Empower 2 photodiode array detector using Zorbax SB C18 column with UV detection at 220 nm. Linearity was observed in the concentration range of Cabazitaxel LOQ-0.10% (R 2 = 0.9998), the concentration range of CBZM01 impurity 0.03-0.225% (R 2 = 0.9997), the concentration range of CBZM02 impurity 0.03-0.225% (R 2 = 0.9997), the concentration range of CBZN09 impurity 0.03-0.225% (R 2 = 0.9998). Limit of detection (%) and the limit of quantitation (ng/mL) were found to be CBZM01 impurity 0.002% and 73ng/mL, CBZM02 impurity 0.002 % and 71ng/mL, CBZN09 impurity 0.002 % and 6ng/mL and Cabazitaxel 0.002 % and 0.008 % respectively. The percent recovery was in good agreement with the labeled amount in the dosage forms and hence, the method is specific, simple, reproducible and accurate for the determination of Cabazitaxel.

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Introduction: A suitable LC-MS method for the quantitative determination of genotoxic impurities such as alkyl p-toluene sulfonates in Cabazitaxel was developed. Alkyl p-toluene sulfonates were estimated by LC-MS method using Waters Symmetry C18 (75×4.6 mm), 3.5 µ column. Materials and Methods: Column temperature was maintained 40 °C. Injection volume was 10 µL and flow rate was set as 0.8 mL/min. Sampler temperature was maintained to 25 °C and run time was set as 25 minutes. The mobile phase was a mixture of ammonium acetate buffer and acetonitrile in 70:30(v/v) was used. Results: The method validation has been carried as per ICH guidelines. LOQ was found to be 2.66 µg/mL, 2.75 µg/mL and 2.55 µg/mL for MPTS, EPTS and IPPTS Alkyl p-Toluene Sulfonates (APTS) respectively. Conclusion: The proposed Liquid chromatography-Mass spectroscopy method that can quantify genotoxic APTS in Cabazitaxel at low-level concentration has been developed and validated as per ICH guidelines. Hence, the proposed method was recommended for the assay of genotoxic impurities of cabazitaxel in dosage forms in busy pharmaceutical laboratories.