Stability indicating UPLC method for simultaneous determination of atorvastatin, fenofibrate and their degradation products in tablets
A stability indicating UPLC method was developed and validated for the simultaneous determination of atorvastatin, fenofibrate and their impurities in tablets. The chromatographic separation was performed on acquity UPLC BEH C18 column (1.7 μm, 2.1 mm × 100 mm) using gradient elution of acetonitrile and ammonium acetate buffer (pH 4.7; 0.01 M) at flow rate of 0.5 ml/min. UV detection was performed at 247 nm. Total run time was 3 min within which main compounds and six other known and major unknown impurities were separated. Stability indicating capability was established by forced degradation experiments and separation of known degradation products. The method was validated for accuracy, repeatability, reproducibility and robustness. Linearity, LOD and LOQ was established for atorvastatin, fenofibrate and their known impurities.
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ACQUITY - XBridge BEH C18 Method Transfer Kit, 130?, 1.7 - 3.5 µm, 2.1 - 4.6 mm X 50 - 100mm, 2/p...
186004964
ACQUITY - XBridge BEH C18 Method Transfer Kit, 130?, 1.7 - 5 µm, 2.1 - 4.6 mm X 50 - 150mm, 2/pkg
186004958
ACQUITY - XBridge BEH C18 Method Transfer Kit, 130?, 1.7 - 3.5 µm, 2.1 - 4.6 mm X 100 - 150mm, 2/...
186004971
ACQUITY PREMIER BEH C18 Column, 1.7 µm, 2.1 x 50 mm, 1/pk
186009452
ACQUITY PREMIER BEH C18 Column with VanGuard FIT, 1.7 µm, 2.1 x 50 mm, 1/pk
186009455
ACQUITY PREMIER BEH C18 Column, 1.7 µm, 2.1 x 100 mm, 1/pk
186009453
ACQUITY PREMIER BEH C18 Column, 1.7 µm, 2.1 x 150 mm, 1/pk
186009454
ACQUITY PREMIER BEH C18 VanGuard FIT Cartridge, 1.7 µm, 2.1 x 5 mm, 3/pk
186009459
ACQUITY PREMIER BEH C18 Column with VanGuard FIT, 1.7 µm, 2.1 x 100 mm, 1/pk
186009457
ACQUITY PREMIER BEH C18 Column with VanGuard FIT, 1.7 µm, 2.1 x 150 mm, 1/pk
186009458
ACQUITY PREMIER Peptide BEH C18 Column, 300?, 1.7 µm, 2.1 x 100 mm, 1/pk
186009494
ACQUITY PREMIER Peptide BEH C18 Column, 300?, 1.7 µm, 2.1 x 50 mm, 1/pk
186009493
ACQUITY PREMIER Peptide BEH C18 Column, 300?, 1.7 µm, 2.1 x 150 mm, 1/pk
186009495
ACQUITY PREMIER Peptide BEH C18 Column, 130?, 1.7 µm, 2.1 x 50 mm, 1/pk
186009481
ACQUITY PREMIER Peptide BEH C18 Column, 130?, 1.7 µm, 2.1 x 150 mm, 1/pk
186009483
ACQUITY PREMIER Peptide BEH C18 Column, 130?, 1.7 µm, 2.1 x 100 mm, 1/pk
186009482
ACQUITY UPLC BEH C18 Column, 130?, 1.7 µm, 1 mm X 150 mm, 3/pkg
176001044
ACQUITY UPLC BEH C18 Column, 130?, 1.7 µm, 3 mm X 100 mm, 1/pkg
186004661
ACQUITY UPLC BEH C18 Column, 130?, 1.7 µm, 2.1 mm X 150 mm, 3/pkg
176001048
ACQUITY UPLC BEH C18 Column, 130?, 1.7 µm, 3 mm X 50 mm, 1/pkg
186004660
ACQUITY UPLC BEH C18 Column, 130?, 1.7 µm, 2.1 mm X 150 mm, 1/pkg
186002353
ACQUITY UPLC BEH C18 Column, 130?, 1.7 µm, 2.1 mm X 100 mm, 1/pkg
186002352
ACQUITY UPLC BEH C18 Column, 130?, 1.7 µm, 2.1 mm X 50 mm, 1/pkg
186002350
ACQUITY UPLC BEH C18 Column, 130?, 1.7 µm, 1 mm X 50 mm, 1/pkg
186002344
ACQUITY UPLC BEH C18 Column, 130?, 1.7 µm, 1 mm X 100 mm, 3/pkg
176000862
ACQUITY UPLC BEH C18 Column, 130?, 1.7 µm, 2.1 mm X 50 mm, 3/pkg
176000863
ACQUITY UPLC BEH C18 Column, 130?, 1.7 µm, 1 mm X 100 mm, 1/pkg
186002346
ACQUITY UPLC BEH C18 Column, 130?, 1.7 µm, 2.1 mm X 100 mm, 3/pkg
176000864
ACQUITY UPLC BEH C18 Column, 130?, 1.7 µm, 1 mm X 150 mm, 1/pkg
186002347
ACQUITY UPLC BEH C18 Column, 130?, 1.7 µm, 2.1 mm X 30 mm, 1/pkg
186002349
ACQUITY UPLC BEH C18 Column, 130?, 1.7 µm, 1 mm X 50 mm, 3/pkg
176000861
ACQUITY UPLC BEH C18 Column, 130?, 1.7 µm, 3 mm X 30 mm, 1/pkg
186004659
ACQUITY UPLC BEH C18 Column, 130?, 1.7 µm, 3 mm X 100 mm, 3/pkg
176001796
ACQUITY UPLC BEH C18 Column, 130?, 1.7 µm, 3 mm X 30 mm, 3/pkg
176001794
ACQUITY UPLC BEH C18 Column, 130?, 1.7 µm, 2.1 mm X 30 mm, 3/pkg
176001304
ACQUITY UPLC BEH C18 Column, 130?, 1.7 µm, 3 mm X 150 mm, 3/pkg
176001797
ACQUITY UPLC BEH C18 Column, 130?, 1.7 µm, 3 mm X 150 mm, 1/pkg
186004690
ACQUITY UPLC BEH C18 Column, 130?, 1.7 µm, 3 mm X 75 mm, 1/pkg
186005609
ACQUITY UPLC BEH C18 Method Validation Kit, 130?, 1.7 µm, 2.1 mm X 100 mm, 3/pkg
186004045
ACQUITY UPLC BEH C18 Method Validation Kit, 130?, 1.7 µm, 2.1 mm X 50 mm, 3/pkg
186004044
ACQUITY UPLC BEH C18 Method Validation Kit, 130?, 1.7 µm, 2.1 mm X 150 mm, 3/pkg
186006019
ACQUITY UPLC BEH C18 Column, 130?, 1.7 µm, 3 mm X 50 mm, 3/pkg
176001795
ACQUITY UPLC BEH C18 VanGuard Pre-column, 130?, 1.7 µm, 2.1 mm X 5 mm, 3/pkg
186003975
ACQUITY UPLC BEH C18 Method Validation Kit, 130?, 1.7 µm, 3 mm X 100 mm, 3/pkg
186004692
ACQUITY UPLC BEH C18 Method Validation Kit, 130?, 1.7 µm, 3 mm X 50 mm, 3/pkg
186004691
ACQUITY UPLC Oligonucleotide BEH C18 Column, 130?, 1.7 µm, 2.1 mm X 100 mm, 1/pkg
186003950
ACQUITY UPLC Peptide BEH C18 Column, 300?, 1.7 µm, 2.1 mm X 100 mm, 1/pkg
186003686
ACQUITY UPLC Peptide BEH C18 Column, 300?, 1.7 µm, 2.1 mm X 150 mm, 1/pkg
186003687
ACQUITY UPLC Peptide BEH C18 Column, 300?, 1.7 µm, 2.1 mm X 50 mm, 1/pkg
186003685
ACQUITY UPLC Oligonucleotide BEH C18 Method Validation Kit, 130?, 1.7 µm, 2.1 mm X 100 mm, 3/pkg
186004898
ACQUITY UPLC Oligonucleotide BEH C18 Column, 130?, 1.7 µm, 2.1 mm X 50 mm, 1/pkg
186003949
ACQUITY UPLC Peptide BEH C18 Method Validation Kit, 300?, 1.7 µm, 2.1 mm X 100 mm, 3/pkg
186004897
ACQUITY UPLC Peptide BEH C18 Method Validation Kit, 130?, 1.7 µm, 2.1 mm X 100 mm, 3/pkg
186004896
ACQUITY UPLC Peptide BEH C18 Column, 130?, 1.7 µm, 2.1 mm X 50 mm, 1/pkg
186003554
ACQUITY UPLC Peptide BEH C18 Column, 300?, 1.7 µm, 1 mm X 50 mm, 1/pkg
186005592
ACQUITY UPLC Peptide BEH C18 Column, 130?, 1.7 µm, 2.1 mm X 100 mm, 1/pkg
186003555
ACQUITY UPLC Peptide BEH C18 Column, 300?, 1.7 µm, 1 mm X 100 mm, 1/pkg
186005593
ACQUITY UPLC Peptide BEH C18 Column, 130?, 1.7 µm, 2.1 mm X 150 mm, 1/pkg
186003556
ACQUITY UPLC Peptide BEH C18 Method Validation Kit, 130?, 1.7 µm, 2.1 mm X 150 mm, 3/pkg
186006516
ACQUITY UPLC Peptide BEH C18 Column, 300?, 1.7 µm, 1 mm X 150 mm, 1/pkg
186005594
ACQUITY UPLC Peptide BEH C18 Method Validation Kit, 300?, 1.7 µm, 2.1 mm X 150 mm, 3/pkg
186006517
ACQUITY UPLC Oligonucleotide BEH C18 Column, 130?, 1.7 µm, 2.1 mm X 150 mm, 1/pkg