Comparative Pharmacokinetic Studies of Marketed and Microsponges Gel Loaded with Diclofenac Diethylamine in Rabbits

2021 ◽  
pp. 6385-6391
Author(s):  
Naresh Kshirasagar ◽  
Goverdhan Puchchakayala ◽  
Balamurugan. K
Keyword(s):  
Oral Administration ◽  
High Performance ◽  
Quantitative Estimation ◽  
Internal Standard ◽  
Hepatic Metabolism ◽  
Topical Administration ◽  
Pharmacokinetic Profile ◽  
Hplc Method ◽  
Pharmacokinetic Studies ◽  
Pharmaceutical Dosage Forms

Oral administration of the non-steroidal anti-inflammatory drug, Diclofenac Diethylamine (DDEA) is often associated with gastrointestinal ulcers, bleeding and extensive first-pass hepatic metabolism. As an alternative to oral administration, formulated microsponges-based gel of DDEA was developed for topical administration, to quantify diclofenac diethylamine in plasma of rabbits for this a sensitive Reverse Phase High-Performance Liquid Chromatography (RP-HPLC) method was developed using carbamazepine as Internal standard (IS) and DDEA (pure drug) was provoked on Hypersil RP C18 column (250mm × 4.6mm 5µm) using a mobile phase mixture of potassium dihydrogen buffer pH 2.5 and acetonitrile in the ratio of 30:70 v/v at an isocratic flow rate of 1mL/min. The drug peak area was detection and found at 276nm. The retention time of DDEA was found to be 5.3 min. The calibration curve was linear over the concentration range of 50-750ng/ml of DDEA. This method was accurate for quantitative estimation of the drug from the marketed gel and optimized microsponge gel. The main of investigation is to compare pharmacokinetic profile of diclofenac diethylamine in pharmaceutical dosage forms (marketed gel and microsponges gel) using WinNonlin software version 8.1.

scholarly journals Robust and Sensitive High-Performance Liquid Chromatographic-UV Detection Technique for the Determination of Tigecycline in Rabbit Plasma

2011 ◽  
Vol 94 (3) ◽  
pp. 847-856 ◽  
Author(s):  
Kostas M Zorpas ◽  
Georgia N Valsami ◽  
Evangelos V Vryonis ◽  
Athanasios T Skoutelis ◽  
Helen A Archontaki
Keyword(s):  
High Performance ◽  
Internal Standard ◽  
Pharmacokinetic Profile ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Pharmacokinetic Studies ◽  
Rabbit Plasma ◽  
Elution Time ◽  
Liquid Chromatographic

Abstract An isocratic HPLC method with detection at 248 nm was developed and fully validated for the determination of tigecycline in rabbit plasma. Minocycline was used as an internal standard. A Hypersil BDS RP-C18 column (250 × 4.6 mm, 5 μm particle size) was used with the mobile phase phosphate buffer (pH 7.10, 0.070 M)–acetonitrile (76 + 24, v/v) at a flow rate of 1.0 mL/min. The elution time of tigecycline and minocycline was approximately 8.1 and 9.9 min, respectively. Calibration curves of tigecycline were linear in the concentration range of 0.021–3.15 μg/mL in plasma. The LOD and LOQ in plasma were estimated as 7 and 21 ng/mL, respectively. The intraday and interday precision values of the method were in the range of 5.0–7.1 and 5.6–9.1%, while the corresponding accuracy values were in the ranges of 92.8–111.1 and 97.6–102.3%, respectively. At the LOQ, the intraday precision was 18.7%, while intraday and interday accuracy values were 97.3 and 98.0%, respectively. Robustness of the proposed method was studied using a Plackett-Burman experimental design. A pharmacokinetic profile is presented for confirmation of the applicability of the method to pharmacokinetic studies.

scholarly journals DEVELOPMENT AND VALIDATION OF A SIMPLE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY–UV METHOD FOR THE DETERMINATION OF VINORELBINE - A CHEMOTHERAPEUTIC DRUG IN SPIKED HUMAN PLASMA

2019 ◽  
Vol 12 (1) ◽  
pp. 369
Author(s):  
Useni Reddy Mallu ◽  
Venkateswara Rao Anna ◽  
Bikshal Babu Kasimala
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
Human Plasma ◽  
High Performance ◽  
Internal Standard ◽  
Hplc Method ◽  
Pharmacokinetic Studies ◽  
Chemotherapeutic Drug ◽  
Spiked Human Plasma ◽  
Rp Hplc

Objective: Vinorelbine (VNRB) is a chemotherapeutic drug used to treat non-small cell lung cancer and breast cancer. Literature survey reveals that there are no reverse-phase high-performance liquid chromatography (RP-HPLC) methods reported for the estimation of VNRB in spiked human plasma. Hence, the present work aimed to develop a simple and efficient RP-HPLC method for the estimation of VNRB in human plasma.Methods: Specimen preparation for the measurement of VNRB was performed through liquid-liquid extraction using methanol as extracting solvent and reconstructed with mobile phase. Paclitaxel (PCTX) was used as internal standard. HPLC method was optimized and validated as per the US FDA bioanalytical guidelines. VNRB and internal standard were separated on Kromasil® C18 (250×4.6 mm; id 5 μ) using acetate buffer (pH=5.9) and methanol in the ratio of 85:15 (v/v) at 1 ml/min flow rate. Eluted compounds were recorded using UV detector at 235 nm.Results: The retention time of PCTX and internal standard was found to be 4.3 and 9.0 min, respectively. The analytical measuring ranges were found to be 5–750 ng/ml (r2>0.9998). The method was found to be simple, accurate, precise, and stable and there is no interference of plasma matric components.Conclusion: The described HPLC method allows for the measurement of total and free PCTX in both plasma and cord blood and can utilize for the estimation of drug in pharmacokinetic studies.

Simultaneous Determination of Three Coumarins in Rat Plasma by HPLC-MS/MS for Pharmacokinetic Studies Following Oral Administration of Chimonanthi Radix Extract

2020 ◽  
Vol 58 (10) ◽  
pp. 922-928
Author(s):  
Jing Zhang ◽  
Quan Wen ◽  
Meng-ying Zhou ◽  
Chen-cong Zhong ◽  
Yulin Feng ◽  
...  
Keyword(s):  
Oral Administration ◽  
High Performance ◽  
Multiple Reaction Monitoring ◽  
Internal Standard ◽  
Gradient Elution ◽  
Rat Plasma ◽  
Pharmacokinetic Studies ◽  
Bioactive Constituents ◽  
Liquid Chromatography Tandem Mass ◽  
Multiple Reaction Monitoring Mode

Abstract Chimonanthi Radix (CR) is widely used in the treatment of influenza in China. Extensive studies revealed that the major bioactive constituents of CR were coumarins. However, pharmacokinetic study of coumarins in CR has not been fully studied. The purpose of this study was to establish a convenient and effective high-performance liquid chromatography–tandem mass spectrometry method that was used to simultaneously determine scopoletin, scopolin and isofraxidin in rat plasma after oral administration of CR extract using xanthotoxin as the internal standard. The chromatographic separation was carried out on a COSMOCORE C18 column (100 × 2 mm, 2.6 μm), using gradient elution with the mobile phase consisting of 0.1% formic acid (A) and acetonitrile (B). Three coumarins and IS were quantified by positive ion electrospray ionization in multiple reaction monitoring mode. The method was fully validated in terms of specificity, accuracy, precision (intra- and inter-day), matrix effect, recovery as well as the stability of the analytes under various conditions. The results could provide further research foundation for anti-influenza mechanism of three coumarins in CR.

scholarly journals DEVELOPMENT AND VALIDATION OF A SIMPLE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY–UV METHOD FOR THE DETERMINATION OF VINORELBINE - A CHEMOTHERAPEUTIC DRUG IN SPIKED HUMAN PLASMA

2019 ◽  
Vol 12 (1) ◽  
pp. 369 ◽  
Author(s):  
Useni Reddy Mallu ◽  
Venkateswara Rao Anna ◽  
Bikshal Babu Kasimala
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
Human Plasma ◽  
High Performance ◽  
Internal Standard ◽  
Hplc Method ◽  
Pharmacokinetic Studies ◽  
Chemotherapeutic Drug ◽  
Spiked Human Plasma ◽  
Rp Hplc

Objective: Vinorelbine (VNRB) is a chemotherapeutic drug used to treat non-small cell lung cancer and breast cancer. Literature survey reveals that there are no reverse-phase high-performance liquid chromatography (RP-HPLC) methods reported for the estimation of VNRB in spiked human plasma. Hence, the present work aimed to develop a simple and efficient RP-HPLC method for the estimation of VNRB in human plasma.Methods: Specimen preparation for the measurement of VNRB was performed through liquid-liquid extraction using methanol as extracting solvent and reconstructed with mobile phase. Paclitaxel (PCTX) was used as internal standard. HPLC method was optimized and validated as per the US FDA bioanalytical guidelines. VNRB and internal standard were separated on Kromasil® C18 (250×4.6 mm; id 5 μ) using acetate buffer (pH=5.9) and methanol in the ratio of 85:15 (v/v) at 1 ml/min flow rate. Eluted compounds were recorded using UV detector at 235 nm.Results: The retention time of PCTX and internal standard was found to be 4.3 and 9.0 min, respectively. The analytical measuring ranges were found to be 5–750 ng/ml (r2>0.9998). The method was found to be simple, accurate, precise, and stable and there is no interference of plasma matric components.Conclusion: The described HPLC method allows for the measurement of total and free PCTX in both plasma and cord blood and can utilize for the estimation of drug in pharmacokinetic studies.

scholarly journals Improved HPLC Method for the Determination of Moxifloxacin in Application to a Pharmacokinetics Study in Patients with Infectious Diseases

2013 ◽  
Vol 2013 ◽  
pp. 1-7 ◽  
Author(s):  
Nan Wang ◽  
Liqin Zhu ◽  
Xuequn Zhao ◽  
Wenjie Yang ◽  
He Sun
Keyword(s):  
Human Plasma ◽  
High Performance ◽  
Room Temperature ◽  
Internal Standard ◽  
Hplc Method ◽  
Single Step ◽  
Pharmacokinetic Studies ◽  
Liquid Liquid Extraction ◽  
High Concentrations

Objective. To develop a simple and rapid high-performance liquid chromatography (HPLC) method for measuring moxifloxacin concentration in human plasma. Methods. Following a single step liquid-liquid extraction, analytes along with an internal standard (IS) were separated using an isocratic mobile phase of 0.1% triethylamine (adjusted pH to 4.8 with phosphoric acid)/acetonitrile (80/20, v/v) at flow rate of 1 mL/min on reverse phase Kromasil C18 column (250 mm × 4.6 mm, 5 μm) at room temperature. Results. Total analytical run time for selecting moxifloxacin was 15 min. The assays exhibited good linearity (r2=0.9998) over the studied range of 25 to 5000 ng/mL. The absolute recovery rate of low, medium, and high concentrations were 69.88%, 78.86%, and 78.51%, respectively. The relative recovery rates were 98.50%, 96.61%, and 101.79%, respectively. Coefficient of variation and error at both of the intraday and interday assessments were less than 4.7%. Conclusions. The results indicated that this method is a simple, rapid, precise and accurate assay for the determination of moxifloxacin concentrations in human plasma. This validated method is sensitive and reproducible enough to be used in pharmacokinetic studies.

scholarly journals A New Validated RP- HPLC Method for the Determination of Nevirapine in Human Plasma

2010 ◽  
Vol 7 (3) ◽  
pp. 821-826 ◽  
Author(s):  
C. H. Venkata Kumar ◽  
D. Ananth Kumar ◽  
J. V. L. N. Seshagiri Rao
Keyword(s):  
Human Plasma ◽  
High Performance ◽  
Ammonium Acetate ◽  
Internal Standard ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Pharmacokinetic Studies ◽  
Liquid Chromatographic Method ◽  
Liquid Chromatographic

A rapid, selective and sensitive high performance liquid chromatographic method for the estimation of nevirapine in human plasma has been developed. Chromatography was carried out on a Hypersil BDS C18column using a mixture of ammonium acetate buffer (pH 4.0 ± 0.05) and acetonitrile (85:15 v/v) as the mobile phase. The eluents were monitored for the drug by UV detection at 254 nm. Oxcarbazepine was used as an internal standard for this study. The retention times for nevirapine and oxcarbazepine were found to be 7.2 and 14.7 min respectively. The method was found to be linear in the concentration range of 50 ng/mL to 5003.7 ng/mL. The method was validated as per FDA guidelines and was found to be suitable for bioequivalence and pharmacokinetic studies.

scholarly journals Validated RP-HPLC Method for the Assay of Etoricoxib (A Non-Steroidal Anti-Inflammatory Drug) in Pharmaceutical Dosage Forms

2012 ◽  
Vol 9 (2) ◽  
pp. 832-838 ◽  
Author(s):  
Srinivasu Topalli ◽  
T. G. Chandrashekhar ◽  
M. Mathrusri Annapurna
Keyword(s):  
High Performance ◽  
Limit Of Detection ◽  
Potassium Dihydrogen Phosphate ◽  
Internal Standard ◽  
High Performance Liquid Chromatographic ◽  
Dosage Forms ◽  
Hplc Method ◽  
Dihydrogen Phosphate ◽  
Limit Of Quantification ◽  
Pharmaceutical Dosage Forms

A simple, accurate, sensitive and reproducible reverse phase high performance liquid chromatographic method has been developed for the quantitative determination of Etoricoxib in pharmaceutical dosage forms. The assay was performed on Hypersil ODS C-18 (250 x 4.6 mm., 5µm particle size) column using acetonitrile and potassium dihydrogen phosphate buffer (pH 4.2) (46:54 % v/v) as mobile phase with UV detection at 280 nm (flow rate 1.2 ml/min). Bromhexine was used as an internal standard. Quantization was achieved by measurement of the peak area ratio of the drug to the internal standard. The limit of detection (LOD) and the limit of quantification (LOQ) were 0.0704 µg ml-1and 0.2134 µg ml-1respectively. Each analysis required no longer than 10 minutes. The calibration curve was linear over the concentration range from 0.5-85.0 µg ml-1. The retention times of Etoricoxib and Bromhexine were found to be 3.083 and 7.631 minutes respectively. The proposed method was validated according to the ICH guidelines and can be used successfully to analyse marketed formulations.

scholarly journals RP-HPLC Method Development and Validation for Determination of Didanosine in Pharmaceutical Dosage Forms

2019 ◽  
Vol 9 (4-s) ◽  
pp. 343-347
Author(s):  
Sachin Gholve ◽  
Sharddha Gangapure ◽  
Mahesh Birajdar ◽  
Imran Mujewar ◽  
Omprakash G Bhusnure
Keyword(s):  
High Performance ◽  
Method Development ◽  
Limit Of Detection ◽  
Quantitative Estimation ◽  
Chromatographic Determination ◽  
Dosage Forms ◽  
Hplc Method ◽  
Pharmaceutical Dosage Forms ◽  
Rp Hplc ◽  
Ich Guidelines

To develop a simple, cheap, accurate, and rapid Reverse Phase High Performance Liquid Chromatographic (RP-HPLC) method and validate as per ICH guidelines for estimation of Didanosine in pharmaceutical dosage forms. The separation was conducted by using mobile phase consisting of methanol: water in the ratio (30:70). The wavelength was found at 246nm. Agilent 1220 Infinity LC with ezchrome software is used for chromatographic determination. The separation was conducted by using Zebra Eclipse XDB-C-18 (4.6×250×5µm) at the flow rate of 1.0 ml/min using variable wavelength detector. The developed method resulted in didanosine eluting at 4.650 min. The method was found to be linear over the concentration range 2-12µg/ml with coefficient regression R2-0.997. Mean recovery was found to be in the range of 99.99%, during accuracy studies. The limit of detection (LOD) and limit of quantitiation (LOQ) was found to be 5 mg/ml and 16 mg/ml respectively. A cheap, accurate, precise, linear and rapid RP-HPLC method was developed and validated for the quantitative estimation of Didanosine as per ICH guidelines. Keywords:-RP-HPLC, Didanosine, Method Validation

scholarly journals A New Approach to the RP-HPLC Method for Simultaneous Estimation of Atorvastatin Calcium and Fenofibrate in Pharmaceutical Dosage Forms

2012 ◽  
Vol 9 (3) ◽  
pp. 1223-1229 ◽  
Author(s):  
S. D. Bhinge ◽  
S. M. Malipatil ◽  
A. Jondhale ◽  
R. Hirave ◽  
A. S. Savali
Keyword(s):  
Mobile Phase ◽  
High Performance ◽  
Internal Standard ◽  
Reversed Phase ◽  
Hplc Method ◽  
Raw Material ◽  
Simultaneous Estimation ◽  
Pharmaceutical Dosage Forms ◽  
Atorvastatin Calcium ◽  
Rp Hplc

The present manuscript describes the development and validation of an isocratic reverse phase high-performance liquid chromatographic (RP-HPLC) method for the estimation of Atorvastatin calcium and Fenofibrate in raw material and tablet. Atorvastatin Calcium, Fenofibrate and Diclofenac (internal standard) were well separated using a reversed phase column and mobile phase consisting of acetonitrile:KH2PO4(50 mM) (72:28v/v) (pH 4.1). The mobile phase was pumped at 1.0 mL/min flow rate and atorvastatin calcium and fenofibrate were detected by UV-Vis detection at 260 nm. The retention time for atorvastatin calcium, Internal Standard and fenofibrate were 4.34, 5.35 and 12.05 min, respectively. The LOD and LOQ was found to be 1.95 and 4.80 µg/mL for atorvastatin calcium whereas for fenofibrate it was found to be 1.73 and 3.98 µg/mL in mobile phase. The developed method was validated by applying parameters as precision, accuracy, selectivity, reproducibility and system suitability tests.

scholarly journals Comparative evaluation of moxifloxacin MDR-TB drug; as microspheres with respect to pure drug in lung tissue

2016 ◽  
Vol 2 (2) ◽  
pp. 103
Author(s):  
Sanaul Mustafa ◽  
V.Kusum Devi
Keyword(s):  
Oral Administration ◽  
Lung Tissue ◽  
High Performance ◽  
Internal Standard ◽  
High Performance Liquid Chromatographic ◽  
Reversed Phase ◽  
Pharmacokinetic Studies ◽  
Uv Detector ◽  
Relative Standard ◽  
Emulsification Solvent Evaporation

A novel moxifloxacin (MOX)-loaded poly (DL-lactide-co-glycolide) (PLGA) microspheres (MPs) suitable for oral administration was prepared by double emulsification solvent evaporation (w/o/w) method. To investigate the pharmacokinetic of MOX-MPs, a simple and rapid high performance liquid chromatographic method was developed for the quantification of MOX in plasma and lung tissue of rats treated with MOX-MPs. Gatifloxacin (0.2µg/ml) was used as an internal standard (IS). The chromatographic separation was achieved on a reversed phase C18 column using isocratic elution with (0.01% Triethanolamine in distilled water): Acetonitrile in the ratio 70:30 v/v pH 2 adjusted with ortho-phosphoric acid, at flow rate of 1 ml/min with a total run time of 6 min. The column effluent was monitored by UV detector at 290 nm. The assay was found to be linear and validated over the concentration range 0.025 to 3.2 µg/ml for MOX in plasma and 0.1 to 2.5 µg/g of lung tissue with correlation coefficient of r2 0.9998 and r2 0.9997 respectively. The system was found to construct sharp peaks for MOX and IS with retention times of 4.08 (±0.012) and 5.84 (±0.026) min for plasma, and 4.17 (±0.016) and 5.84 (±0.022) for lung tissue, respectively. The method exhibited accuracy, precision (inter-day relative standard deviation (RSD) and intra-day RSD values < 15.0 %. The method was applied for determining MOX concentration in plasma and lung after oral administration of 10mg/kg of free MOX and MOX MPs to rats. Results established selectivity and suitability of the method for pharmacokinetic studies of MOX from MOX-MPs

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