Browsing by Author "Moges Mesfin"

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    Hoptly Method Development and Validation for Simultaneous Determination of Lamivudine and Tenofovir in Fixed Dose Combination Tablet
    (Addis Ababa University, 2009-06) Moges Mesfin; Debela Asfaw
    Lamivudine and tenofovir disoproxil fumarate are antiretroviral drugs available in a fixed dosecombination tablet. They are nucleoside analogues and an increasingly important member ofantiretroviral drugs.HPTLC-densitometry method was developed and validated for simultaneous determination ofantiretroviral drugs tenofovir disoproxil fumarate and lamivudine in fixed dose combi nations.The method was based on HPTLC separation of the two drugs followed by densitometricmeasurements of their spots at 257 nm. Toluene-methanol (6:4, v/v) was used as mobile phaseand HPTLC aluminum sheets of si lica gel 60 F254 as stationary phase and detection of the spotswere made by observation under short wavelength (254 nm) UV li ght. The system was foundto give compact spot for lamivudine (Rr= 0.32 ± 0.02) and tenofovir disoproxil fumarate (Rr =0.57 ± 0.02). The method was validated for precision, accuracy and robustness. The linearregression analysis data for the calibration plots showed good linear relationship with r2 =0.998 in the concentration range 100-900 ng/spot for tenofovir disoproxil fumarate and linearrelationship with r2 = 0.994 in the concentration range 200-800 ng/spot for lamivudine. Themean value of determination coefficient, slope and intercept were 0.998 ± 0.0012 and 0.994 ±0.002, 4.80 ± 0.076 and 8. 12 ± 0.21 , 232.80 ± 36.21 and 478.16 ± 72.85 for tenofovirdisoproxil fumarate and lamivudine, respectively. The intra-day and inter-day precision wasless than 3% relative standard deviation (RSO <3%). The LOO and LOQ were 24.89 and 75.40ng/spot for tenofovir disoproxil fumarate and 29.60 and 89.72 for lamivudine, respectively.The percentage assay of tenofovir disoproxil fumarate and lamivudine was found 98.63 ± 2. 17and 100.93 ± 1.32, respectively.The described method has the advantage of being rapid, simple and inexpensive. Nochromatographic interferences between the excipients and active ingredients were found. Themethod therefore could be applied for routine quality control analysis of lamivudine andtenofovir di soproxil flUllarate in fixed dose combination tablet. Key words: Lamivudine; Tenofovir Oisoproxil Fumarate; HPTLC-Oensitometty;Method validation
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    HPTLC method Development and Validation for Simultaneous Determination of Lamivudine and Tenofovir in Fixed Dose Combination Tablet
    (Addis Ababa University, 2009-06) Moges Mesfin; Debela Asfaw
    HPTLC-densitometry method was developed and validated for simultaneous determination ofantiretroviral drugs tenofovir disoproxil fumarate and lamivudine in fixed dose combi nations.The method was based on HPTLC separation of the two drugs followed by densitometricmeasurements of their spots at 257 nm. Toluene-methanol (6:4, v/v) was used as mobile phaseand HPTLC aluminum sheets of si lica gel 60 F254 as stationary phase and detection of the spotswere made by observation under short wavelength (254 nm) UV li ght. The system was foundto give compact spot for lamivudine (Rr= 0.32 ± 0.02) and tenofovir disoproxil fumarate (Rr =0.57 ± 0.02). The method was validated for precision, accuracy and robustness. The linearregression analysis data for the calibration plots showed good linear relationship with r2 =0.998 in the concentration range 100-900 ng/spot for tenofovir disoproxil fumarate and linearrelationship with r2 = 0.994 in the concentration range 200-800 ng/spot for lamivudine. Themean value of determination coefficient, slope and intercept were 0.998 ± 0.0012 and 0.994 ±0.002, 4.80 ± 0.076 and 8. 12 ± 0.21 , 232.80 ± 36.21 and 478.16 ± 72.85 for tenofovirdisoproxil fumarate and lamivudine, respectively. The intra-day and inter-day precision wasless than 3% relative standard deviation (RSO <3%). The LOO and LOQ were 24.89 and 75.40ng/spot for tenofovir disoproxil fumarate and 29.60 and 89.72 for lamivudine, respectively.The percentage assay of tenofovir disoproxil fumarate and lamivudine was found 98.63 ± 2. 17and 100.93 ± 1.32, respectively.The described method has the advantage of being rapid, simple and inexpensive. Nochromatographic interferences between the excipients and active ingredients were found. Themethod therefore could be applied for routine quality control analysis of lamivudine andtenofovir di soproxil flUllarate in fixed dose combination tablet. Key words: Lamivudine; Tenofovir Oisoproxil Fumar ate; HPTLC-Oensitometty;Method validation