DEVELOPMENT AND VALIDATION OF STABILITY-INDICATING HPTLC METHOD FOR DETERMINATION OF DARUNAVIR ETHANOLATE AND RITONAVIR
Keywords:
Darunavir, Ritonavir, HPTLC, Forced degradationAbstract
Objective: To develop and validate a new simple, accurate, precise and selective stability-indicating high performance thin layer chromatographic (HPTLC) method for simultaneous estimation of Darunavir ethanolate and Ritonavir in combined tablet dosage form as per ICH guidelines.
Methods: Chromatographic separation of drugs was performed on precoated silica gel aluminium plate 60 F254 (10 ×10) with 250 µm thicknesses (E. MERCK, Darmstadt, Germany) using a CAMAG Linomat 5 sample applicator (Switzerland). The mobile phase selected was Toluene: Ethyl acetate: Methanol (6: 2.5: 1.5, v/v/v) with UV detection at 250 nm.
Results: The retention factor for Darunavir ethanolate and Ritonavir was found to be 0.29±0.005 and 0.50±0.07. Results were found to be linear in the concentration range of 200-1000 ng band-1for both the drugs. Intra-day variation, as RSD (%), was found to be in the range of 0.45 to 1.54 for Darunavir ethanolate and 0.22 to 0.64 for Ritonavir. Interday variation, as RSD (%) was found to be in the range of 0.64 to 1.48 for Darunavir ethanolate and 0.13 to 1.24 for Ritonavir. The lower values of % RSD obtained have proved that the method is precise and robust.
Conclusion: Stability-indicating HPTLC method was developed and validated for simultaneous estimation Darunavir ethanolate and Ritonavir and can be used for assessing the stability of Darunavir ethanolate and Ritonavir in bulk drug and pharmaceutical dosage form.
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References
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