Simple Bioanalytical Quantification Method for Simultaneous Estimation of Simvastatin and Ezetimibe in Human Plasma by Reverse-Phase High-Performance Liquid Chromatography Technique

Objective: The current research work focus to simple and rugged bioanalytical method development and validation of brivudine in human plasma using high-performance liquid chromatography. Methods: The analyte (Brivudine) and internal standard (Sofosbuvir) were extracted using the Solid Phase Extraction (SPE) technique. The chromatographic separation was accomplished by using Zorbax eclipse XDB-C18 Column (150×4.6 mm, 5 μm) with a mobile phase consisted of Methanol: 0.5% Ortho-phosphoric acid (65:35%, v/v) respectively, at a flow rate of 0.7 mL/min. The developed method was validated by performing system suitability, carryover effect, linearity, selectivity, sensitivity, precision, accuracy, recovery, ruggedness, and stability studies. The method was validated as per USFDA guidelines. Results: The selected chromatographic condition was found to efficiently separated brivudine (RT-3.55 min) and ISTD (RT-7.87 min). The assay demonstrated a linear dynamic range of 85.205 to 4500.246 ng/ml for brivudine in human plasma with r2>0.99. Demonstrated the lowest limit of detection at 85.205 ng/ml. This method established an intra-run and inter-run precision within the range of 2.99-6.31%CV and 3.67-5.80%CV, respectively. Additional intra-run and inter-run accuracy were within the range of 97.55-105.37% and 99.27-102.15%, respectively. The mean percentage recovery of brivudine and ISTD studies proved good extraction efficiency and the robustness was also evaluated. Conclusion: A simple, accurate, precise, linear and rugged RP-HPLC method was developed and validated for the estimation of brivudine in human plasma with K2EDTA anticoagulant and suitable for conducting BA/BE and TDM.

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“…Method validation was done as per the criteria of industrial guidance for the bioanalytical method validation of USFDA [14][15][16].…”

Section: Methods Validationmentioning

confidence: 99%

A Simple and Rugged Bioanalytical Method Development and Validation of Brivudine in Human Plasma by Using High-Performance Liquid Chromatography

Satheshkumar

Muruganantham

2020

Int J Pharm Pharm Sci

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“…It also represents the precision of the method under the same operating conditions over a short period. Re-injection reproducibility shall be evaluated by re-injecting anyone of the accepted P & A [82][83][84][85].…”

Section: Reinjection Reproducibilitymentioning

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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Applicability of Comprehensive Mobile Phase in Validated Bio Analytical Quantitative Estimation of Rosuvastatin, Ezetimibe, Amlodipine, Valsartan, Lercanidipine and Fluvastatin in Human Plasma by Rp-HPLC Method

Dyade¹,

Sawant²

2022

IND. DRU.

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A bio analytical method was developed with compatible mobile phase for estimation of drugs viz. rosuvastatin and ezetimibe, amlodipine and valsartan, lercanidipine and fluvastatin in human plasma. Liquid chromatographic system takes ample of time to stabilise and to attain equilibrium on changeover of mobile phase. Compatible mobile phase was beneficial to separate and estimate many drugs simultaneously; and saved time and solvent consumption. The technique was developed and equipped with reverse phase high performance liquid chromatograph (RP-HPLC), using RP - C18 column with UV detector. For estimation of all these drugs, the mobile phase [acetonitrile: acetate buffer pH 4.0 (pH adjusted with acetic acid)] was pumped at a flow rate of 0.8 mL min-1 in the ratio of 60:40 V/V and the eluents were monitored at 245 nm. The method was studied and validated as per ICH guidelines and US FDA guidelines for selectivity, specificity, accuracy and precision and stability study. All these drugs shown linear response between concentration and response as a peak area and chromatograms with well resolved peaks were sign of methods efficiency. Statistical data of calibration graph to study linearity of these drugs in biological matrix was found within prescribed limit. Prepared quality control samples were estimated, accuracy and precision results of rosuvastatin and ezetimibe were 97-100.93 as % nominal concentration and 0.8210-2.0367 as % CV for amlodipine and valsartan 98.43-99.81 as % nominal conc. and 0.9480-2.4753 as % CV and for lercanidipine and fluvastatin 97.18-103.5 as % nominal conc and 0.5258-3.8301 as % CV and were within prescribed limit. The bio analytical method is simple as it is free from solvent extraction and solid phase extraction, precise, accurate, and consumes less solvent due to compatible mobile phase. The method suits for quantification of these drugs in plasma, hence applied for bio equivalence, bioavailability study in real clinical samples.

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Simple Bioanalytical Quantification Method for Simultaneous Estimation of Simvastatin and Ezetimibe in Human Plasma by Reverse-Phase High-Performance Liquid Chromatography Technique

Cited by 3 publications

References 13 publications

A Simple and Rugged Bioanalytical Method Development and Validation of Brivudine in Human Plasma by Using High-Performance Liquid Chromatography

A Simple and Rugged Bioanalytical Method Development and Validation of Brivudine in Human Plasma by Using High-Performance Liquid Chromatography

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

Applicability of Comprehensive Mobile Phase in Validated Bio Analytical Quantitative Estimation of Rosuvastatin, Ezetimibe, Amlodipine, Valsartan, Lercanidipine and Fluvastatin in Human Plasma by Rp-HPLC Method

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