Quantification of newer anticancer drug enzalutamide by stability indicating RP-LC method and UV-visible spectroscopic method in bulk and synthetic mixture.

Abstract

An accurate, sensitive, selective and precise stability indicating Isocratic RP-LC method and UVvisible Spectroscopic method were developed for the quantitative determination of enzalutamide in bulk and synthetic mixture. The HPLC was carried out by reversed-phase technique on Sun fire C18, 5 µm column with mobile phase containing methanol: water (70:30). The flow rate was 1.0 ml/min and effluents were monitored at 234 nm with help of photodiode array (PDA) detector. UV spectroscopic determination was carried out at an absorption maximum of 234 nm using methanol as a solvent. The linearities were in the range of 4-14 µg/ml for UV-visible spectroscopic method and 0.03-20 µg/ml for RP-LC method, respectively. Validation of proposed method has been carried out with respect to linearity, accuracy, precision, specificity and robustness. Stock solution of EZA was subjected to acid and alkali hydrolysis, chemical oxidation, dry heat degradation and photolytic degradation and quantification has been carried out by proposed RP-LC method. Enzalutamide is susceptible to acidic and basic hydrolysis while it is stable towards chemical oxidation, dry heat and photolytic stress condition. Statistical comparison of both the method has been carried out by Student's F-test showed no significant difference between the results obtained by the two methods. Due to sensitivity, rapidity and accuracy of methods, we believe that the both proposed methods will be useful for the routine quality control analysis and quantification of drug in bulk and from synthetic mixture.

Characteristics, properties, and analytical and bio‐analytical methods of enzalutamide: A review

“…Zamir et al established a UV spectroscopic technique for determining ENZ in bulk drugs and also in formulations [23]. A stability-indicating RP-LC method and UV-Visible spectroscopic method for the determination of ENZ in bulk drugs were reported [24]. RP-LC Method for quantification of EZA in active pharmaceutical ingredients and formulations was developed [25].…”

“…The order of sensitivity of the detector is mass detector > photodiode array detector > UV detector > densitometry. Among the analytical methods mentioned, the RP-LC method [24] is not only rapid (run time: 6.0 mins) but also sensitive (LOD: 0.03 μg/ml and LOQ: 0.13 μg/ml). This method is linear over the range of 0.03-20 μg/ml.…”

Quality by design with design of experiments approach for development of a stability‐indicating LC method for enzalutamide and its impurities in soft gel dosage formulation

“…Other alternative procedures were also evaluated; for example, Ma, Zhou, Zou, and Ouyang (2016) developed an efficient chromatographic method to separate and quantify impurities in ENZ in bulk drug. Besides, many different methods for detection of impurities in ENZ formulations have been reported (Anjaneyulu Reddy, Radhakrishnanand, Irshad Alam, & Ravi Kiran, 2019; Dousa, 2019; Khan, Patil, & Deshmukh, 2016; Prajapati, Chhalotiya, & Prajapati, 2017; Zamir, Shwetal, Prashant, & Praveen, 2016). The HPLC analytical method proposed by Ma, Zhou, Zou, and Ouyang (2016) has poor resolution between the impurity 4 and Impurity‐5 with ENZ peak.…”