Development of Validated Bioanalytical RP-HPLC Method for Determination of Sofosbuvir In Human Plasma

Satheshkumar, S.; Muruganatham, V.

doi:10.46624/ajptr.2020.v10.i2.007

Cited by 2 publications

(2 citation statements)

References 5 publications

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“…The stability of the analyte and the internal standard should be assessed to cover the maximum period of anticipated subject sample batch run time. Place the processed samples in the auto sampler at the desired temperature and for the estimated period [72][73][74][75][76].…”

Section: Autosampler Stabilitymentioning

confidence: 99%

Bioanalysis Method Development and Validation of Small Molecules in Pharmaceutical Industry: A Bioanalyst Review Point

Satheshkumar

Muruganantham

et al. 2021

Asian J Pharm Clin Res

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The focus of bioanalysis employed for the quantitative determination of an active analyte(s) and their metabolite(s) in the biological matrix such as plasma, serum, blood, cerebrospinal fluid, and tissues. The extraction of analyte and metabolite in the biological fluids is carried out using different separation methods such as protein precipitation, liquid-liquid extraction, and solid phase extraction. Bioanalytical method development and validation in the pharmaceutical industry are to provide an assessment and interpretation of pharmacokinetics, pharmacodynamics, toxicokinetics, bioavailability/bioequivalence, and therapeutic drug monitoring relationships. This review paper aims to provide a simple and accurate scientific background to improve the quality for development and validation of a bioanalytical method for small molecules with industrial technique as per regulatory agency requirements (United States Food and Drug Administration, EMEA, International Council for Harmonisation and ANVISA).

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Section: Autosampler Stabilitymentioning

confidence: 99%

Bioanalysis Method Development and Validation of Small Molecules in Pharmaceutical Industry: A Bioanalyst Review Point

Satheshkumar

Muruganantham

et al. 2021

Asian J Pharm Clin Res

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“…It is a potent dipeptidyl peptidase-4 (DPP-4) inhibitor and exerts pharmacological action by boosting the amounts of certain natural substances that decrease elevated blood sugar. 1,2 Following a meal, the digestive system releases incretin hormones e.g. glucosedependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1), that raises their blood levels.…”

Section: Introductionmentioning

confidence: 99%

Development and Validation of Analytical Method for Linagliptin Drugs in Pharmaceutical Dosage form by RP-HPLC

Avinash¹,

Gandhimathi²

2023

IJPQA

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The objective of the current research was to develop and validate the reversed-phase high performance liquid chromatography (RP-HPLC) method for linagliptin from formulation and bulk material. The development was performed on C18 stainless steel column using 0.1 M TEA pH 5.5 adjusted with OPA and methanol (30:70% v/v) at 0.7 mL/min fl ow rate. Samples were analyzed by 1024 DAD detector at 238 nm. The developed method complied with the system suitability study with acceptable asymmetric factor and number of theoretical plates. The linearity was observed between 10–50 μg/mL concentrations (R2 = 0.999). The mean %recovery of 99.33 to 99.88% with %RSD between 0.13 to 0.24 was observed. The drug content was found within the acceptable limit in interday and intraday precision study. The method was fond robust and small changes in fl ow rate, mobile phase and wavelength did not hamper the accuracy and specifi city of the method and all results were found within acceptable limit. Limit of detection (LoD) and limit of quantitation (LoQ) of 0.17854 and 0.54105 μg/mL, respectively, were observed. This research confi rmed the development of simple, robust, sensitive, accurate and cost-eff ective methods that can be used to analyze Linagliptin using RP-HPLC from tablet and bulk dosage.

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Development of Validated Bioanalytical RP-HPLC Method for Determination of Sofosbuvir In Human Plasma

Cited by 2 publications

References 5 publications

Bioanalysis Method Development and Validation of Small Molecules in Pharmaceutical Industry: A Bioanalyst Review Point

Bioanalysis Method Development and Validation of Small Molecules in Pharmaceutical Industry: A Bioanalyst Review Point

Development and Validation of Analytical Method for Linagliptin Drugs in Pharmaceutical Dosage form by RP-HPLC

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