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Stability Indicating Analytical Method for Estimation of Related substances of Anti-HIV Drugs in Fixed dose Tablet Formulation by RP-HPLC
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| Author:
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PARTH PATEL, T.Y.PASHA, SHYAMAL PATEL, BHUPAT VIHOL, SAGAR SOLANKI, JUHI SADIWALA
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| Abstract:
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Related substance is a test which quantitates impurities in formulation. This research paper presents a logical and scientific development & validation of analytical method for estimation of impurities of Lamivudine, Tenofovir disoproxil fumarate & Efavirenz in fixed dose tablet formulation. Estimation of impurities of Lamivudine, Tenofovir disoproxil fumarate & Efavirenz in fixed dose tablet formulation was conducted by RP-HPLC. The separation was achieved under optimized chromatographic condition on an Inertsil ODS-3 150×4.6mm; 5µm column with mobile phase-A consist of 20mM acetate buffer pH-3.8±0.05: Methanol (95:5 %v/v) & mobile phase-B consist of 20mM acetate buffer pH-3.8±0.05: Methanol (5:95 %v/v) with gradient elution at a flow rate of 1.0 mL/min using 35°C column oven temperature with PDA detection at 260 nm. The method was validated as per ICH and USP guideline and the values were found to be within the limits. So, the proposed method was found to be simple, linear, accurate, precise, robust and specific.
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| Keyword:
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Related substances, Validation, RP-HPLC, Impurities, Lamivudine, Tenofoivr disoproxil fumarate, Efavirenz, Anti-HIV Drugs
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| EOI:
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| DOI:
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https://doi.org/10.31838/ijpr/2021.13.01.659
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| Download:
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