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Identification and quantification of potential genotoxic impurities from Rilpivirine hydrochloride by HPTLC technique

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Vitthal V. Chopade, Dipali S. Thete, Pallavi M. Patil, Ashwini P Shewale, Amita B Dongare, Deepali Kadam, Amol Khedkar, Rahul S Buchade, Pratap S Dabhade, Amit Lunkad, Bindurani L G P Ram, Gaffar Sayyed, Rajendra Kawade, Komal Nanaware, Rajanikant Kakade, Girish M Pathare, Sunanda A Lekurwale, Swapnali E Dalvi, Priyanka M Salve, Atul A Baravkar
» doi: 10.31838/ecb/2023.12.si6.326


A rapid, accurate, selective, and sensitive HPTLC method has been developed and validated for estimation of potential genotoxic impurity A, Impurity B, Impurity C and Impurity D from the standard Rilpivirine hydrochloride. Method: The chromatographic separation was achieved on Automatic Camag Automatic TLC Sampler 4 (ATS4) with Win CATS Planar Chromatography Manager Software Version- 1.4.4, Spray gas: Inert gas (N2) Micro litre syringe (20 μL, 100 μL): Hamilton. Stationary phase was Aluminium plates precoated with silica gel 60 F254. The compound was separated using mobile phase Chloroform: Toluene: Ethanol in the ratio of (4: 4: 1 v/v/v). The mode of application was band with band size 6mm and band distance 17 mm. Densitometric evaluation was performed at 282 nm. Results: Rilpivirine HCl, Impurity A, Impurity B, Impurity C and Impurity D were satisfactorily resolved with obtained Rf values 0.50, 0.58, 0.52, 0.50 and 0.71 respectively. The accuracy and reliability of the method was assessed by evaluation of linearity for Rilpivirine and all four impurities which obtained as 100-350 ng/spot for both drug and impurities with the regression coefficient of 0.9993 and 0.9995, respectively. Precision study found to be intra-day % RSD (1.02–1.08) and inter-day % RSD (1.05 –1.56) for Rilpivirine and all four impurities. The detection and quantification limits were found to be 60.96 and 129.5 ng/spot for both drug and impurities. Conclusion: The proposed method was validated in terms of Linearity, Range, Accuracy, Precision, Specificity and Robustness in accordance with ICH guidelines. The method was successfully applied to the estimation of Rilpivirine hydrochloride and four impurities in standard Rilpivirine hydrochloride

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