scholarly journals Bioanalytical Method Development and Validation of Dapoxetine Hydrochloride in Human Plasma by RP-HPLC

2021 ◽  
Vol 10 (10) ◽  
pp. 21-35
Author(s):  
Pranit. B. Kale Santosh A. Waghmare ◽  
Arun. M. Kashid S. B. Wankhede
Keyword(s):  
Human Plasma ◽  
High Performance ◽  
Method Development ◽  
Method Development And Validation ◽  
Total Analysis ◽  
Serotonin Transport ◽  
Phase Symmetry ◽  
Development And Validation ◽  
Ich Guideline ◽  
Dapoxetine Hydrochloride

A simple, accurate and rapid Bioanalytical reverse phase high performance liquid chromatography (RPHPLC) method for determination of Dapoxetin hydrochloride in human plasma was validated as per ICH guideline. Dapoxetin hydrochloride is significantly superior in premature ejaculation and more active against serotonin transport inhibitor than any other drug in class. The total analysis was carried out on using stationary phase symmetry C1 (4.6mm X 250mm, 5µm) with Mobile Phase Acetonitrile: Buffer (60:40) pH adjusted to3.5 flow rate was 1.0 ml/min, injection volume of 10 ppm and detection wavelength was 293nm at ambient temperature with total run time of 10 minutes. Retention time of spiked plasma and dapoxetine hydrochloride were found to be 2.153 min and 4.442 min, r2 value were 0.995 and 0.999 and linearity range was 5ppm to 25ppm for both. The method was developed for accuracy, linearity, precision, recovery and stability in complies and stability in complies with CDER and ICH guideline.

BIO ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR SIMULANEOUS ESTIMATION OF NITAZOXANIDE AND OFLOXACIN IN HUMAN PLASMA BY RP-HPLC

INDIAN DRUGS ◽  
2021 ◽  
Vol 57 (10) ◽  
pp. 47-57
Keyword(s):  
Human Plasma ◽  
High Performance ◽  
Method Development ◽  
Reversed Phase ◽  
Chromatography Method ◽  
Rp Hplc ◽  
Method Development And Validation ◽  
Liquid Chromatography Method ◽  
Development And Validation ◽  
Lower Limits

An isocratic Reversed-Phase High Performance Liquid Chromatography method has been developed for rapid and simultaneous separation and estimation of two antibiotics, namely, nitazoxanide and ofloxacin, in human plasma. Separation was carried out on Altima C8 (150 x 4.6 mm, 5µ) column using a mobile phase of 0.1% ortho phosphoric acid: acetonitrile (50:50, V/V) at 260 nm. The retention time of nitazoxanide and ofloxacin was noted to be 4.850 and 7.949 min, respectively. The average % recovery for nitazoxanide and ofloxacin were 98.012 % and 94.176 %, respectively and reproducibility was found to be satisfactory. The linearity was investigated in the concentration range of 0.02-2 µg/ml (r2=0.9996) for nitazoxanide and 0.008-0.8 µg/ml (r2=0.9998) for ofloxacin. The lower limits of quantification were 0.0196 µg/ml and 0.0079 µg/ml for nitazoxanide and ofloxacin, respectively, which reach the level of both drugs possibly found in human plasma. The proposed method can be applied for etermination of nitazoxanide and ofloxacin from dosage forms during pharmacokinetic study.

Bioanalytical Method Development and Validation of Naproxen: Application to Bioequivalence Studies

2017 ◽  
Vol 8 (2) ◽  
Author(s):  
Senthil Rajan Dharmalingam ◽  
Srinivasan Ramamurthy ◽  
Sai Siddhardh ◽  
M. D. Basheerudhin
Keyword(s):  
Human Plasma ◽  
Mobile Phase ◽  
High Performance ◽  
Method Development ◽  
Diclofenac Sodium ◽  
Pharmacokinetic Studies ◽  
Chromatography Method ◽  
Method Development And Validation ◽  
Liquid Chromatography Method ◽  
Development And Validation

A new selective and sensitive high-performance liquid chromatography method was developed for the quantification of Naproxen in human plasma using diclofenac sodium asinternal standard (IS). Chromatographic separation was achieved on aPhenomenex GEMINI C18 (150 x 4.6 mm, 5 mm) column. The mobile phase consists of a mixture of Acetonitrile: 0.5% Triethylamine buffer (50:50; v/v) and the pH of the mobile phase was adjusted to 3.5 by 85 % orthophosphoric acid. Flow rate of mobile phase was 1 mL/min.Detection was performed at 230nm. The calibration curve was linear over the concentration range from 10 to 120µg/mL. The detection (LOD) and quantification (LOQ) limits were 10 ng/mL and 25 ng/Ml respectively. The method was validated for accuracy, precision, specificity, robustness, and detection and quantification limits, in accordance with ICH guidelines.The developed method for the determination of Naproxen from human plasma has been found accurate, precise, selective, and suitable for the bioequivalence and pharmacokinetic studies.

scholarly journals A SIMPLE AND RUGGED BIOANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF BRIVUDINE IN HUMAN PLASMA BY USING HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY

2020 ◽  
pp. 45-50
Author(s):  
S. SATHESHKUMAR ◽  
V. MURUGANANTHAM
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
Human Plasma ◽  
High Performance ◽  
Method Development ◽  
Limit Of Detection ◽  
Research Work ◽  
Bioanalytical Method ◽  
Method Development And Validation ◽  
Development And Validation

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.

scholarly journals Bioanalytical method development and validation for determination of metoprolol tartarate and hydrochlorothiazide using HPTLC in human plasma

2013 ◽  
Vol 49 (4) ◽  
pp. 845-851 ◽  
Author(s):  
Ambadas Ranganath Rote ◽  
Poonam Ramdas Sonavane
Keyword(s):  
Human Plasma ◽  
High Performance ◽  
Method Development ◽  
Internal Standard ◽  
Analytical Technique ◽  
Method Development And Validation ◽  
Rf Values ◽  
The Stability ◽  
Development And Validation

A simple, sensitive, rapid and economic chromatographic method has been developed for determination of metoprolol tartarate and hydrochlorothiazide in human plasma using paracetamol as an internal standard. The analytical technique used for method development was high-performance thin-layer chromatography. HPTLC Camag with precoated silica gel Plate 60F254 (20 cm×10 cm) at 250 µm thicknesses (E. Merck, Darmstadt, Germany) was used as the stationary phase. The mobile phase used consisted of chloroform: methanol: ammonia (9:1:0.5v/v/v). Densitometric analysis was carried out at a wavelength of 239 nm. The rf values for hydrochlorothiazide, paracetamol and metoprolol tartarate were 0.13±0.04, 0.28±0.05, 0.48±0.04, respectively. Plasma samples were extracted by protein precipitation with methanol. Concentration ranges of 200, 400, 600, 800, 1000, 1200 ng/mL and 2000, 4000, 6000, 8000, 10000, 12000 ng/mL of hydrochlorothiazide and metoprolol tartarate, respectively, were used with plasma for the calibration curves. The percent recovery of metoprolol tartarate and hydrochlorothiazide was found to be 77.30 and 77.02 %, respectively. The stability of metoprolol tartarate and hydrochlorothiazide in plasma were confirmed during three freeze-thaw cycles (-20 ºC) on a bench for 24 hours and post-preparatively for 48 hours. The proposed method was validated statistically and proved suitable for determination of metoprolol tartarate and hydrochlorothiazide in human plasma.

METHOD DEVELOPMENT AND VALIDATION FOR THE DETERMINATION OF METOPROLOL IN HUMAN PLASMA BY HIGH PERFORMANCE LIQUID CHROMATOGRAPHY

2018 ◽  
Vol 8 (5) ◽  
pp. 96-101
Author(s):  
Khan Nguyen Viet ◽  
Hoai Nguyen Thị
Keyword(s):  
Human Plasma ◽  
High Performance ◽  
Method Development ◽  
Biological Fluids ◽  
Hplc Method ◽  
Fluorescence Detector ◽  
Bioanalytical Method Validation ◽  
Method Development And Validation ◽  
Development And Validation

Background: Metoprolol has been widely used in the treatment of hypertension. The usage of drugs for cardiovascular diseases is highly required safety and effectiveness for patients. Therefore, a convenient method for the determination of metoprolol in plasma is necessary. Objectives: (1) To develope an HPLC method for quantification of metoprolol in human plasma and (2) To validate of the method. Materials and methods: human plasma. Results: Chromatographic conditions include: Eclipse XDB-C18 column, fluorescence detector, mobile phase: acetonitril : NaH2PO4 buffer (25 mmol/L, pH 3.0) with a solvent gradient program. The analytical method met current FDA guidelines for bioanalytical method validation. Conclusions: The method can be applied to determine metoprolol in biological fluids for pharmacokinetic and biocompatibility study. Key words: Metoprolol, plasma, HPLC

Method Development and Validation of Propofol by Reverse Phase HPLC and its Estimation in Commercial Formulation

2021 ◽  
pp. 3139-3142
Author(s):  
Kuntal Mukherjee ◽  
S. T. Narenderan ◽  
B. Babu ◽  
Survi Mishra ◽  
S. N. Meyyanathan
Keyword(s):  
High Performance ◽  
Method Development ◽  
Pharmaceutical Formulations ◽  
High Performance Liquid Chromatographic ◽  
Reverse Phase Hplc ◽  
Liquid Chromatographic Method ◽  
Method Development And Validation ◽  
Development And Validation ◽  
Liquid Chromatographic

A simple, sensitive and rapid high performance liquid chromatographic method has been developed for the determination of Propofol. The main focus of the method was to determine Propofol in solution form as well as in marketed formulation. Chromatographic separation was achieved on Inertsil ODS-3V column (250mm x 4.6mm; 5µm) with a mobile phase consisting of methanol: water (85:15), with a flow rate of 1.0ml/min (UV detection at 270nm). Linearity was observed over the concentration range of 10-110µg/ml with a regression equation y=88048x + 44524 and having a regression value (R2) of 0.999. The LOD and LOQ values found to be 10ng and 100ng, respectively. No changes found in ruggedness and robustness studies. The percentage of recovery was found to be 95.25% to 101.81%. Validation studies revealed that the method was specific, accurate, precise, reliable, robust, reproducible and suitable for the quantitative analysis in its pharmaceutical formulations.

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