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Method Development And Validation For Anti-Retroviral Drug (Efavirenz) By Reverse Phase High Performance Liquid Chromatograph
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| Author:
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, ARUP BHATTACHARYA, SONAM PATEL, GULLAPALLI KOWMUDI, KRISHNAVENI NAGAPPAN
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| Abstract:
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Back Ground: Efavirenz is a non-nucleoside reverse transcriptase inhibitor (NNRTI) used for the first-line treatment of AIDS.
Objective: The aim of the present study is to develop and validate a simple, specific, accurate, precise and linear reverse-phase high performance liquid chromatographic method for the determination & the quantification of Efavirenz in bulk drug as well as in pharmaceutical formulations.
Method: The RP-HPLC method consists of Shimadzu Shim-Pack RP-HPLC column (150mm x 4.6mm, i.d. 5µm) as stationary phase with the mobile phase of 20mM ammonium acetate (pH 3.5): acetonitrile (30:70% v/v) at a flowrate of 0.8ml/min with elution wavelength at 247nm.
Result: In this developed method the retention time of Efavirenz was 6.225 ± 0.2min. The linearity of Efavirenz comes at the range of 200-600ng/ml with R2 >0.99. The precision of the developed method was calculated by the Relative Standard Deviation and the result was found to be <2%. The percent recovery was observed between the ranges (98-101%) of which represent the accuracy of the method. The limit of detection and the limit of quantification are 5ng/ml and 15ng/ml respectively.
Conclusion: A simple, specific, precise, accurate, rapid and linear RP-HPLC method has been developed and validated for the estimation and quantification of anti-retroviral drug (Efavirenz) in bulk drug as well as in pharmaceutical formulations as per ICH Q2 (R1) guidelines. This developed and validated method can further be used for the routine analysis of Efavirenz in various pharmaceutical industries & in Bioequivalence & Bioavailability studies.
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| Keyword:
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Efavirenz, anti-retroviral, RP-HPLC-UV, ICH Q2 (R1), Validation.
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| EOI:
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-
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| DOI:
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https://doi.org/10.31838/ijpr/2020.SP1.367
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| Download:
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