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  • ALENCAL IRBE 2.5 300 MG TABLETAS LOTE 16009 IRBESARTAN-1

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    This document contains chromatograms from an HPLC analysis of Irbesartan and its conjugate. The first two chromatograms show blank runs of the mobile phase and diluent. The third and fourth chromatograms show standard runs of a conjugated Irbesartan standard, with peaks present at 4.97 and 6.15 minutes in one run and 4.96 and 6.14 minutes in the other run. The chromatograms provide data on peak area, retention times, asymmetry, theoretical plates, resolution, and signal to noise for method validation.

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    ALENCAL IRBE 2.5 300 mg TABLETAS LOTE 16009 IRBESARTAN-1

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    This document contains chromatograms from an HPLC analysis of Irbesartan and its conjugate. The first two chromatograms show blank runs of the mobile phase and diluent. The third and fourth chromatograms show standard runs of a conjugated Irbesartan standard, with peaks present at 4.97 and 6.15 minutes in one run and 4.96 and 6.14 minutes in the other run. The chromatograms provide data on peak area, retention times, asymmetry, theoretical plates, resolution, and signal to noise for method validation.

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
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    45 views8 pages

    ALENCAL IRBE 2.5 300 MG TABLETAS LOTE 16009 IRBESARTAN-1

    Uploaded by

    Brendapaez3
    This document contains chromatograms from an HPLC analysis of Irbesartan and its conjugate. The first two chromatograms show blank runs of the mobile phase and diluent. The third and fourth chromatograms show standard runs of a conjugated Irbesartan standard, with peaks present at 4.97 and 6.15 minutes in one run and 4.96 and 6.14 minutes in the other run. The chromatograms provide data on peak area, retention times, asymmetry, theoretical plates, resolution, and signal to noise for method validation.

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Flag for inappropriate content
    of 8

    D-7000 HSM: SEPTIEMBRE Series: 0010 System: HPLC 1

    2018

    LABORATORIO FARBROQUIM S.A.S


    Analyzed Date and Time: 07/09/18 02:40 p.m.
    Processing Method: IRBESARTAN CRA SEP/07/18
    System(acquisition): HPLC MP-01 Vial Type: BLANK
    Sample Name: FASE MOVIL Volume: 10,0 ul
    Sample Description:
    (AU)

    N-Meth 0
    Inhib Inhib
    2,5 Sens 3
    Absorbance

    2,0

    1,5

    1,0

    0,5

    0,0

    0 1 2 3 4 5 6 7 8 9 10
    Retention Time (min)

    Developed by: ANGELA GARCIA Analizado Por: SOFÍA CORREA

    Page Indicator 1 / 8
    D-7000 HSM: SEPTIEMBRE Series: 0010 System: HPLC 1
    2018

    LABORATORIO FARBROQUIM S.A.S


    Analyzed Date and Time: 07/09/18 02:57 p.m.
    Processing Method: IRBESARTAN CRA SEP/07/18
    System(acquisition): HPLC MP-01 Vial Type: BLANK
    Sample Name: DILUENTE Volume: 10,0 ul
    Sample Description:
    (AU)

    N-Meth 0
    Inhib Inhib
    2,5 Sens 3
    Absorbance

    2,0

    1,5

    1,0

    0,5

    0,0

    0 1 2 3 4 5 6 7 8 9 10
    Retention Time (min)

    Developed by: ANGELA GARCIA Analizado Por: SOFÍA CORREA

    Page Indicator 2 / 8
    D-7000 HSM: SEPTIEMBRE Series: 0010 System: HPLC 1
    2018

    LABORATORIO FARBROQUIM S.A.S


    Analyzed Date and Time: 07/09/18 09:42 p.m.
    Processing Method: IRBESARTAN CRA SEP/07/18
    System(acquisition): HPLC MP-01 Vial Type: STD1
    Sample Name: STD CONJUGADO Volume: 10,0 ul
    Sample Description:
    (AU)

    N-Meth 0
    Inhib Inhib
    2,5 Sens 3

    6,15, IRBESARTAN
    Absorbance

    2,0

    4,97, CRA IRBESARTAN


    1,5

    1,0

    0,5

    0,0

    0 1 2 3 4 5 6 7 8 9 10
    Retention Time (min)

    No. RT Name Area BC

    1 4,97 CRA IRBESARTAN 1056112 BB


    2 6,15 IRBESARTAN 9532388 BB

    10588500

    Peak rejection level: 0


    RT Name k' Asym N Res
    (min) (USP) (USP)

    4,97 CRA IRBESARTAN 495,67 1,23 3540 ---


    6,15 IRBESARTAN 614,33 1,17 4256 3,34

    RT Name Alpha S/N Noise


    (min) (uV)

    4,97 CRA IRBESARTAN --- 1414,67 115,41


    6,15 IRBESARTAN 1,24 11134,24 115,41

    Asymmetry warning outside the range of: 0,800 to 2,000


    No. of theoretical plates warning at less than: 500
    Resolution warning at less than: 2,000
    Signal to noise ratio warning at less than: 3
    Developed by: ANGELA GARCIA Analizado Por: SOFÍA CORREA

    Page Indicator 3 / 8
    D-7000 HSM: SEPTIEMBRE Series: 0010 System: HPLC 1
    2018

    LABORATORIO FARBROQUIM S.A.S


    Analyzed Date and Time: 07/09/18 09:54 p.m.
    Processing Method: IRBESARTAN CRA SEP/07/18
    System(acquisition): HPLC MP-01 Vial Type: STD1
    Sample Name: STD CONJUGADO Volume: 10,0 ul
    Sample Description:
    (AU)

    N-Meth 0
    Inhib Inhib
    2,5 Sens 3

    6,14, IRBESARTAN
    Absorbance

    2,0

    4,96, CRA IRBESARTAN


    1,5

    1,0

    0,5

    0,0

    0 1 2 3 4 5 6 7 8 9 10
    Retention Time (min)

    No. RT Name Area BC

    1 4,96 CRA IRBESARTAN 1074763 BB


    2 6,14 IRBESARTAN 9686432 BB

    10761195

    Peak rejection level: 0


    RT Name k' Asym N Res
    (min) (USP) (USP)

    4,96 CRA IRBESARTAN 495,00 1,22 3583 ---


    6,14 IRBESARTAN 613,00 1,15 4258 3,33

    RT Name Alpha S/N Noise


    (min) (uV)

    4,96 CRA IRBESARTAN --- 1447,70 115,41


    6,14 IRBESARTAN 1,24 11334,84 115,41

    Asymmetry warning outside the range of: 0,800 to 2,000


    No. of theoretical plates warning at less than: 500
    Resolution warning at less than: 2,000
    Signal to noise ratio warning at less than: 3
    Developed by: ANGELA GARCIA Analizado Por: SOFÍA CORREA

    Page Indicator 4 / 8
    D-7000 HSM: SEPTIEMBRE Series: 0010 System: HPLC 1
    2018

    LABORATORIO FARBROQUIM S.A.S


    Analyzed Date and Time: 07/09/18 10:05 p.m.
    Processing Method: IRBESARTAN CRA SEP/07/18
    System(acquisition): HPLC MP-01 Vial Type: STD1
    Sample Name: STD CONJUGADO Volume: 10,0 ul
    Sample Description:
    (AU)

    N-Meth 0
    Inhib Inhib
    2,5 Sens 3

    6,11, IRBESARTAN
    Absorbance

    2,0

    4,94, CRA IRBESARTAN


    1,5

    1,0

    0,5

    0,0

    0 1 2 3 4 5 6 7 8 9 10
    Retention Time (min)

    No. RT Name Area BC

    1 4,94 CRA IRBESARTAN 1082509 BB


    2 6,11 IRBESARTAN 9720637 BB

    10803146

    Peak rejection level: 0


    RT Name k' Asym N Res
    (min) (USP) (USP)

    4,94 CRA IRBESARTAN 493,00 1,24 3548 ---


    6,11 IRBESARTAN 610,33 1,18 4240 3,32

    RT Name Alpha S/N Noise


    (min) (uV)

    4,94 CRA IRBESARTAN --- 1454,88 115,41


    6,11 IRBESARTAN 1,24 11401,63 115,41

    Asymmetry warning outside the range of: 0,800 to 2,000


    No. of theoretical plates warning at less than: 500
    Resolution warning at less than: 2,000
    Signal to noise ratio warning at less than: 3
    Developed by: ANGELA GARCIA Analizado Por: SOFÍA CORREA

    Page Indicator 5 / 8
    D-7000 HSM: SEPTIEMBRE Series: 0010 System: HPLC 1
    2018

    LABORATORIO FARBROQUIM S.A.S


    Analyzed Date and Time: 07/09/18 10:17 p.m.
    Processing Method: IRBESARTAN CRA SEP/07/18
    System(acquisition): HPLC MP-01 Vial Type: STD1
    Sample Name: STD CONJUGADO Volume: 10,0 ul
    Sample Description:
    (AU)

    N-Meth 0
    Inhib Inhib
    2,5 Sens 3

    6,06, IRBESARTAN
    Absorbance

    2,0

    4,91, CRA IRBESARTAN


    1,5

    1,0

    0,5

    0,0

    0 1 2 3 4 5 6 7 8 9 10
    Retention Time (min)

    No. RT Name Area BC

    1 4,91 CRA IRBESARTAN 1082428 BB


    2 6,06 IRBESARTAN 9706382 BB

    10788810

    Peak rejection level: 0


    RT Name k' Asym N Res
    (min) (USP) (USP)

    4,91 CRA IRBESARTAN 489,67 1,24 3533 ---


    6,06 IRBESARTAN 605,00 1,17 4226 3,28

    RT Name Alpha S/N Noise


    (min) (uV)

    4,91 CRA IRBESARTAN --- 1460,31 115,41


    6,06 IRBESARTAN 1,24 11457,50 115,41

    Asymmetry warning outside the range of: 0,800 to 2,000


    No. of theoretical plates warning at less than: 500
    Resolution warning at less than: 2,000
    Signal to noise ratio warning at less than: 3
    Developed by: ANGELA GARCIA Analizado Por: SOFÍA CORREA

    Page Indicator 6 / 8
    D-7000 HSM: SEPTIEMBRE Series: 0010 System: HPLC 1
    2018

    LABORATORIO FARBROQUIM S.A.S


    Analyzed Date and Time: 07/09/18 10:29 p.m.
    Processing Method: IRBESARTAN CRA SEP/07/18
    System(acquisition): HPLC MP-01 Vial Type: STD1
    Sample Name: STD CONJUGADO Volume: 10,0 ul
    Sample Description:
    (AU)

    N-Meth 0
    Inhib Inhib
    Sens 3

    6,04, IRBESARTAN
    2,5
    Absorbance

    2,0

    4,89, CRA IRBESARTAN


    1,5

    1,0

    0,5

    0,0

    0 1 2 3 4 5 6 7 8 9 10
    Retention Time (min)

    No. RT Name Area BC

    1 4,89 CRA IRBESARTAN 1088909 BB


    2 6,04 IRBESARTAN 9759312 BB

    10848221

    Peak rejection level: 0


    RT Name k' Asym N Res
    (min) (USP) (USP)

    4,89 CRA IRBESARTAN 488,33 1,24 3526 ---


    6,04 IRBESARTAN 603,00 1,18 4218 3,27

    RT Name Alpha S/N Noise


    (min) (uV)

    4,89 CRA IRBESARTAN --- 1470,94 115,41


    6,04 IRBESARTAN 1,23 11556,83 115,41

    Asymmetry warning outside the range of: 0,800 to 2,000


    No. of theoretical plates warning at less than: 500
    Resolution warning at less than: 2,000
    Signal to noise ratio warning at less than: 3
    Developed by: ANGELA GARCIA Analizado Por: SOFÍA CORREA

    Page Indicator 7 / 8
    D-7000 HSM: SEPTIEMBRE Series: 0010 System: HPLC 1
    2018

    LABORATORIO FARBROQUIM S.A.S


    Analyzed Date and Time: 08/09/18 12:48 a.m.
    Processing Method: IRBESARTAN CRA SEP/07/18
    System(acquisition): HPLC MP-01 Vial Type: UNK
    Sample Name: M1 LOTE 16009 Volume: 10,0 ul
    Sample Description: ALENCAL IRBE 2,5 300 mg TABLET
    (AU)

    N-Meth 0
    Inhib Inhib
    2,5 Sens 3
    Absorbance

    6,03, IRBESARTAN
    2,0

    1,5

    1,0

    0,5

    0,0

    0 1 2 3 4 5 6 7 8 9 10
    Retention Time (min)

    No. RT Name Area BC

    CRA IRBESARTAN 0
    1 6,03 IRBESARTAN 18157174 BB

    18157174

    Peak rejection level: 0


    RT Name k' Asym N Res
    (min) (USP) (USP)

    6,03 IRBESARTAN 602,33 1,14 3752 ---

    RT Name Alpha S/N Noise


    (min) (uV)

    6,03 IRBESARTAN --- 19715,17 115,41

    Asymmetry warning outside the range of: 0,800 to 2,000


    No. of theoretical plates warning at less than: 500
    Resolution warning at less than: 2,000
    Signal to noise ratio warning at less than: 3
    Developed by: ANGELA GARCIA Analizado Por: SOFÍA CORREA

    Page Indicator 8 / 8

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