scholarly journals Development and Validation of RP–HPLC Method for Estimation of Curcumin from Nanocochleates and Its Application in in–vivo Pharmacokinetic Study

2020 ◽  
Vol 67 (4) ◽  
pp. 110-1110
Author(s):  
Sameer Nadaf ◽  
Suresh Killedar
Keyword(s):  
Rat Plasma ◽  
Hplc Method ◽  
Pharmacokinetic Parameters ◽  
Statistical Control ◽  
Rp Hplc ◽  
Relative Standard ◽  
Validation Parameters ◽  
Limit Of Quantitation ◽  
Development And Validation

A reliable RP-HPLC analytical method with UV detection at 421 nm was developed and validated for the quantitative determination of curcumin from rat plasma after oral administration of curcumin loaded nanocochleates (CU-NC) to rats. The chromatographic separation was performed on HIQ SIL, C18 (250 mm × 4.6 mm) column using methanol and water (80:20 v/v) as mobile phase, at 1.0 mL/min flow rate. Validation parameters included linearity, accuracy, precision, and limit of quantitation and detection. Good linearity was obtained over the range of 2.5–100 μg/mL (R2 = 0.9979) of curcumin. The developed HPLC method was precise, with <2% relative standard deviation. Accuracy, stability, and robustness studies were also found to be acceptable. Bland-Altman plot showed an acceptable repeatability coefficient. The method was under statistical control, revealed by a control chart. After CU–NC administration, pharmacokinetic parameters i.e. Cmax, AUC0-∞, and AUMC0-∞, were observed to be 97.69 ± 10.84 μg/mL, 1402.77 ± 9.67 (μg/mL) ∙ h, and 35140.16 ± 14.67 (μg/mL) ∙ h2, respectively. This simple and precise method can be effectively implemented for routine analysis.

scholarly journals Development and Validation of a RP-HPLC Method for Quantitative Analysis of Linagliptin in Bulk and Dosage Forms

2018 ◽  
Vol 17 (2) ◽  
pp. 175-182
Author(s):  
Joy Chandra Rajbangshi ◽  
Md Mahbubul Alam ◽  
Md Shahadat Hossain ◽  
Md Samiul Islam ◽  
Abu Shara Shamsur Rouf
Keyword(s):  
Limit Of Detection ◽  
Dosage Forms ◽  
Hplc Method ◽  
Pharmaceutical Dosage Forms ◽  
Rp Hplc ◽  
System Suitability ◽  
Relative Standard ◽  
Limit Of Quantitation ◽  
Precision Limit ◽  
Development And Validation

This research was aimed to establish a versatile, sensitive, rapid and validated RP-HPLC method to analyze linagliptin in bulk as well as in pharmaceutical dosage forms. Liquid chromatography was performed on HPLC system and 20μl of samples were injected into a C18 column (150 x 4.6 mm i.d., 5μm particle size) and the eluents were monitored through a PDA detector at 239 nm. An isocratic method with a flow rate of 1 ml/min was used to elute the compounds with a mobile phase comprised of 70:30 v/v mixture of phosphate buffer (pH 6.8±0.2) and acetonitrile. The retention time of the compound was found to be 2.8 minutes. According to the ICH Q2(R1) guidelines, the method was validated by establishing several analytical parameters such as system suitability, specificity, linearity, accuracy, precision, limit of detection (LOD), limit of quantitation (LOQ), ruggedness and robustness to assay linagliptin. The method showed good linearity (R2 = 0.9981) over the concentration ranges of 40 – 60 μg/ml with a recovery between 99.48% ± 0.38% RSD to 100.22% ± 0.011% RSD, whereas the LOD and LOQ values were 0.05 μg/ml and 0.15 μg/ml, respectively. The relative standard deviation (% RSD) for inter-day and intra-day precision was not more than 2.0%. Hence, the proposed method can be applied accurately for research and routine analysis of linagliptin in bulk as well as different pharmaceutical dosage forms. Dhaka Univ. J. Pharm. Sci. 17(2): 175-182, 2018 (December)

scholarly journals Development and Validation of RP-HPLC Chromatographic Dissolution Method for the Simultaneous Estimation of Ramipril and Hydrochlorothiazide from Solid Dosage Formulation

2021 ◽  
pp. 203-217
Author(s):  
Prabhakar V. Raut ◽  
Sudhakar L. Padwal ◽  
Madhusudhan T. Bachute ◽  
Satish A. Polshettiwar
Keyword(s):  
Method Development ◽  
Theoretical Plate ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Dissolution Medium ◽  
Dissolution Method ◽  
Rp Hplc ◽  
Relative Standard ◽  
Limit Of Quantitation ◽  
Development And Validation

The present study describes the dissolution method development and validation of Ramipril and Hydrochlorothiazide in tablet dosage form by HPLC Method. A simple, rapid, selective, reproducible and isocratic reversed-phase high performance liquid chromatographic (RP-HPLC) method has been developed and validated as per ICH guidelines. Analysis was performed on a Thermo, Sunniest C8 (150 mm x 4.6 mm, 5 µm) with the mobile phase consisting of mixing 500 mL of buffer solution and 500 mL of acetonitrile at a flow rate of 1.0mL/min. UV detection was performed at 210nm and the Run time for Ramipril and Hydrochlorothiazide were 10 minutes. The calibration curve was linear (correlation coefficient = 1.000) in the selected range for both analytes. The optimized dissolution conditions include the USP Type 1 (Basket) rotation rate of 100 rpm and 750 mL of 0.1 N Hydrochloric acid as dissolution medium, at 37.0 ± 0.5°C. The method was validated for precision, linearity, specificity, accuracy, limit of quantitation and ruggedness. The system suitability parameters, such as theoretical plate, tailing factor and relative standard deviation (RSD) between six standard replicates were well within the limits. The stability result shows that the drug is stable in the prescribed dissolution medium.

Rapid and Sensitive Liquid Chromatographic Method for Determination of Anastrozole in Different Polymer–Lipid Hybrid Nanoparticles

2021 ◽  
pp. 247263032098230
Author(s):  
Dilshad Ahmad ◽  
Faisal A. Al Meshaiti ◽  
Yazeed K. Al Anazi ◽  
Osama Al Owassil ◽  
Alaa Eldeen B. Yassin
Keyword(s):  
High Performance ◽  
Limit Of Detection ◽  
Reversed Phase ◽  
Hplc Method ◽  
Hybrid Nanoparticles ◽  
Array Detector ◽  
Relative Standard ◽  
Validation Parameters ◽  
Limit Of Quantitation ◽  
Inhibitor Drug

Anastrozole, an aromatase inhibitor drug, is used for the treatment of breast cancer in pre- and postmenopausal women. Anastrozole’s incorporation into nanoparticulate carriers would enhance its therapeutic performance. To perceive the exact loaded amount of drug in nanocarriers, a valid analytical method is required. The reversed-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated by using the C18 column, 150 × 4.6 mm, 5 µm particle size, in isocratic mobile phase composed of 50:50 V/V (volume/volume) acetonitrile–phosphate buffer (pH 3) flowing at a rate of 1.0 mL/min, and a diode array detector (DAD) set at λmax = 215 nm. The validation parameters such as linearity, accuracy, specificity, precision, and robustness have proven the accuracy of the method, with the relative standard deviation percentage (% RSD) values < 2. The limit of detection of the method was found equal to 0.0150 µg/mL, and the limit of quantitation was 0.0607 µg/mL. The percent recovery of sample was in the range of 98.04–99.25%. The method has the advantage of being rapid with a drug retention time of 2.767 min, specific in terms of resolution of peaks void of interference with any of the excipients, and high reproducibility. This makes it highly applicable for quality control purposes.

scholarly journals SIMULTANEOUS DETERMINATION OF DIPHENHYDRAMINE, EPHEDRINE, NOSCAPINE, AND GLYCEROL GLYCOLATE USING STABILITY-INDICATING HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY: APPLICATION TO NOSCOF TABLETS

2019 ◽  
pp. 505-511
Author(s):  
PULAGURTHA BHASKARARAO ◽  
GOWRI SANKAR DANNANA
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Uv Light ◽  
Reversed Phase ◽  
Hplc Method ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Relative Standard ◽  
Validation Parameters

Objective: Noscof tablet is a fixed dosage combination formulation having diphenhydramine (DH), ephedrine (ED), noscapine (NP), and glycerol glycolate (GG). A sensitive, selective, accurate, precise, and stability-indicating reversed-phase high-performance liquid chromatography (RP-HPLC) method with photodiode array detection has been developed and validated for simultaneous analysis of DH, ED, NP, and GG in bulk drug and Noscof tablets. Methods: Reversed-phase chromatographic separation and analysis of DH, ED, NP, and GG were done on an Altima C18 column with 0.01 M KH2PO4 buffer (pH 3.5) and acetonitrile (50:50%, v/v) as mobile phase at 0.8 ml/min flow rate in isocratic mode. Detection was performed at 260 nm. The method was validated in harmony with International Conference on Harmonization (ICH) guidelines. The tablet sample solution was subjected to diverse stress conditions using ICH strategy such as hydrolytic degradation (neutral - with distilled water, alkaline - with 2 N NaOH, and acidic - with 2 N HCl), oxidation (with 10% H2O2), photodegradation (exposing to UV light), and dry heat degradation (exposing to 105°C). Results: Using the above stated chromatographic conditions, sharp peaks were obtained for ED, NP, DH, and GG with retention time of 3.272 min, 4.098 min, 5.467 min, and 6.783 min, respectively. Good regression coefficient values were obtained in the range of 2–12 μg/ml for ED, 3.75–22.5 μg/ml for NP, 3.125–18.75 μg/ml for DH, and 25–150 μg/ml for GG. The quantification limits were 0.181 μg/ml, 0.187 μg/ml, 0.246 μg/ml, and 1.114 μg/ml for ED, NP, DH, and GG, respectively. The values of validation parameters are within the acceptance limits given by ICH. The ED, NP, DH, and GG showed more percent of degradation in acid condition and less percent of degradation in the neutral condition. The peaks of degradants did not interfere with the peaks of analytes. ED, NP, DH, and GG were assessed with a good percentage of the assay (near to 100%) and low percent relative standard deviation (<2%) in Noscof tablets using the proposed method. Conclusion: The stability indicating RP-HPLC method developed was suitable for quantifying ED, NP, DH, and GG simultaneously in bulk as well as in tablet formulation.

scholarly journals Analytical Method Development and Validation of Rp-Hplc Method for Simultaneous Estimation of Pyridoxamine Dihydrochloride and Acetylcysteine in Tablet Dosage Form.

2021 ◽  
Vol 23 (06) ◽  
pp. 992-1000
Author(s):  
Sneha S. Ghule ◽  
◽  
Ashpak M. Tamboli ◽  
Snehal D. Patil ◽  
◽  
...  
Keyword(s):  
High Performance ◽  
Method Development ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Rp Hplc ◽  
System Suitability ◽  
Validation Parameters ◽  
Method Development And Validation ◽  
Development And Validation ◽  
Tablet Dosage

A reverse-phase high-performance liquid chromatography (RP-HPLC) method for the simultaneous estimation of Pyridoxamine dihydrochloride and Acetylcysteine in the marketed formulation is developed. Chromatography carried out at 30oc temperature on Agilent Zorbax Bonus-RP (250 x 4.6 mm, 5 µ) coloum. Coloum using a mobile phase 0.1% trifluroacetic acid in water: acetonitrile (80:20v/v) with flow rate 1ml/min (DAD scan at 210nm). Validation parameters such as system suitability, linearity, precision, accuracy are considered as reported International Conference on Harmonization guidelines. The retention times for Pyridoxamine dihydrochloride and Acetylcysteine are 2 min and 3.4 min. The linearity range for Pyridoxamine dihydrochloride and Acetylcysteine is 30-70 µg/ml and 180-420 µg/ml. The %RSD for accuracy was found to be less than 2%. Hence the proposed method was found to be accurate, precise, reproducible, and specific and can be used for simultaneous analysis of these drugs in tablet formulation.

Ecofriendly chromatographic methods for determination of co-prescribed drugs, olanzapine and metformin, in rat plasma

Bioanalysis ◽  
2020 ◽  
Vol 12 (9) ◽  
pp. 597-613
Author(s):  
Aml A Emam ◽  
Neven M Habib ◽  
Hamada M Mahmoud ◽  
Nada S Abdelwhab ◽  
Maha M Abdelrahman
Keyword(s):  
Pharmaceutical Preparation ◽  
Rat Plasma ◽  
Reversed Phase ◽  
Hplc Method ◽  
Hypoglycemic Agent ◽  
Chromatographic Methods ◽  
Rp Hplc ◽  
Development And Validation ◽  
Developing System

Background: Olanzapine (OLZ) is one of most recommended drugs for the treatment of schizophrenia while metformin (MET) is the most commonly used hypoglycemic agent. Aim: Development and validation of two green, sensitive and accurate chromatographic methods for the simultaneous determination of OLZ along with the co-prescribed, MET. Materials & methods: TLC-densitometric method with a developing system consisting of methylene chloride:methanol:ethyl acetate:triethylamine (4:4:5:0.1, by volume) and a reversed-phase (RP)-HPLC method where the chromatographic separation was performed using ethanol:water mixture (50: 50, v/v) as a mobile phase. Results: TLC-densitometric method had linearity over concentration ranges of 160–4000 ng/band for OLZ and 150–4500 ng/band for MET, while RP-HPLC method was linear and validated over concentration range of 300–20000 ng/ml for OLZ and MET. Conclusion: Pharmacokinetic study was successfully performed and suggested the possibility of co-administration of MET with OLZ and their further formulation in one pharmaceutical preparation to enhance patient’s compliance.

Development and validation of an RP-HPLC method for the quantitation of Orteronel (TAK-700), a CYP17A1 enzyme inhibitor, in rat plasma and its application to a pharmacokinetic study

2013 ◽  
Vol 27 (12) ◽  
pp. 1590-1594 ◽  
Author(s):  
Avinash Kumar ◽  
Vijay Kumar S ◽  
Sandip Gurav ◽  
Mohd Zainuddin ◽  
Purushottam Dewang ◽  
...  
Keyword(s):  
Pharmacokinetic Study ◽  
Enzyme Inhibitor ◽  
Rat Plasma ◽  
Hplc Method ◽  
Rp Hplc ◽  
Development And Validation

Development and Validation of an RP-HPLC Method for Determination of Atorvastatin and its Hydroxyl Metabolites in Human Plasma

2020 ◽  
Vol 16 (3) ◽  
pp. 238-245
Author(s):  
Dagmara Sowińska ◽  
Alicja Pogorzelska ◽  
Marlena Rakicka ◽  
Justyna Sznura ◽  
Justyna Janowska ◽  
...  
Keyword(s):  
Human Plasma ◽  
Internal Standard ◽  
Hplc Method ◽  
Active Metabolites ◽  
Peak Separation ◽  
Rp Hplc ◽  
Increased Risk ◽  
Relative Standard ◽  
Development And Validation

Background: Atorvastatin (AT) belongs to cholesterol-lowering agents, commonly used in patients with an increased risk of cardiovascular disease. The drug, as well as its hydroxyl metabolites, exhibit pharmacological activity, and their plasma levels may be helpful in the assessment of the therapeutic effectiveness. Objective: Development and validation of a fast and reproducible RP-HPLC method with UV detection for the simultaneous determination of atorvastatin and its active metabolites, para-hydroxy-atorvastatin (p-OH-AT) and ortho-hydroxy-atorvastatin (o-OH-AT) in human plasma. Methods: Optimal conditions of chromatographic separation of the analytes, as well as rosuvastatin, chosen as an internal standard, were studied. The absorbance of the compounds was measured at λ=248 nm. Validation of the method was performed. The usefulness of the method was confirmed for determination of the analytes in plasma of patients treated with the drug. Results: Total peak separation was achieved at LiChrospher 100 RP-18 column with a mobile phase composed of methanol and water (1:1,v:v) and a flow rate of 1.2 ml/min. The method was linear in the ranges of 0.025 - 1.0 μg/ml for AT, o-OH-AT and p-OH-AT. Intra- and inter-assay precision expressed as relative standard deviation was ≤13% for AT, ≤12% for p-OH-AT and ≤11% for o-OH-AT. Intraand inter-day accuracy of the method, expressed as a relative error, was ≤15%. Conclusion: The elaborated HPLC method is specific, repeatable, reproducible, adequately accurate and precise and fulfills the validation requirements for the bioanalytical method. The method was successfully applied for analysis of atorvastatin and its o-hydroxy metabolite in plasma of patients treated with the drug.

scholarly journals Bioanalytical Method Development and Validation for the Determination of Favipiravir in Spiked Human Plasma by using RP-HPLC

2021 ◽  
pp. 275-281
Author(s):  
Pallavi V. Duse ◽  
Kamalkishor G. Baheti
Keyword(s):  
Human Plasma ◽  
Hplc Method ◽  
Therapeutic Drug ◽  
Pharmacokinetic Studies ◽  
Gradient System ◽  
Spiked Human Plasma ◽  
Rp Hplc ◽  
Relative Standard ◽  
Limit Of Quantitation

A precise, simple and reproducible reverse phase liquid chromatography (RP-HPLC) method was developed and validated for determination of Favipiravir by using Carbamazepine as internal standard in spiked human plasma. A chromatographic separation was accomplished with Cromasil C18 (250mm x 4.6ID, Particle size: 5 micron) column using mobile phase consists of methanol: water in the ratio (35:65, %v/v), at pH 3.0 with binary gradient system-maintained flow rate at 0.8ml/min. The detection wavelength of drug sample was at 225 nm. Extraction was done by using ethyl acetate as extracting solvent. The retention time of Favipiravir was found to be 6.62 min.  The method was found to be linear in the concentration range of 0.2-3.2 µg/ml. Limit of quantitation (LOQ) value was found to be 0.72. The intra- and inter day precision and accuracy lies within the specified range. The recovery studies were found to be in the range of 97.6 to 100.2%. %Relative standard deviation (RSD) was found to be in the range of 0.07-2.80%. All parameters were found to be validated from spiked human plasma. The proposed RP-HPLC method is highly accurate and rapid for the determination of favipiravir in human plasma and can be applied for pharmacokinetic studies and Therapeutic drug monitoring.

DEVELOPMENT AND VALIDATION OF NEW RP–HPLC METHOD FOR DETERMINATION OF BESIFLOXACIN IN ANIMAL MODEL

INDIAN DRUGS ◽  
2015 ◽  
Vol 52 (01) ◽  
pp. 26-32
Author(s):  
A Singh ◽  
◽  
C. L Singh ◽  
S. Kumar ◽  
M. Kumar
Keyword(s):  
High Performance ◽  
Internal Standard ◽  
Rat Plasma ◽  
Reversed Phase ◽  
Hplc Method ◽  
Standard Curve ◽  
Absorbance Detection ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Development And Validation

A sensitive and accurate reversed– phase high performance liquid chromatography (RP-HPLC) method with UV absorbance detection at 289 nm was developed and validated for the determination and quantification of besifloxacin (BSF) in rat plasma. Ofloxacin was used as an internal standard (IS). The sample was prepared by liquid extraction of BSF from plasma, using methanol and acetonitrile (70:30). The chromatographic separation was achieved with octadecylsilane (ODS-3), Hypersil® C18 column (250 mm×6mm×5μm). The chromatographic runtime was less than 5 minutes where the retention time of internal standard and the drug was 2.15 min and 3.30 min respectively. A standard curve with a regression coefficient (r2) 0.999 was obtained in the range of 0.025-20 μg/mL. The method was validated with respect to linearity, range, precision, accuracy and robustness according to ICH guidelines. The method was found to be accurate and robust with a runtime of less than 5 minutes. Hence, the present method was rapid and economical to use for clinical studies as well as to analyze the drug in different plasma samples.

Sign in / Sign up

Export Citation Format

Share Document