A NEW BIOANALYTICAL METHOD DEVELOPMENT & VALIDATION FOR SIMULTANEOUS ESTIMATION OF METFORMIN HYDROCHLORIDE AND SITAGLIPTIN PHOSPHATE MONOHYDRATE IN HUMAN PLASMA BY USING RP-HPLC

INDIAN DRUGS ◽  
2014 ◽  
Vol 51 (12) ◽  
pp. 18-25
Author(s):  
S. A Kumar ◽  
◽  
M Debnath ◽  
J. V. L. N. S Rao ◽  
G Sankar
Keyword(s):  
Human Plasma ◽  
Mobile Phase ◽  
Method Development ◽  
Hplc Method ◽  
Precipitation Method ◽  
Metformin Hydrochloride ◽  
Simultaneous Estimation ◽  
Dihydrogen Phosphate ◽  
Rp Hplc

A new RP-HPLC method for the quantitative determination of metformin and sitagliptin in human plasma was developed and validated as per US-FDA guidelines. The drug was spiked in the plasma and extracted with mobile phase by precipitation method. The extracted analyte was injected into Symmetry C18 (4.6 x 150 mm, 3.5μm, Make: XTerra) or equivalent, maintained at ambient temperature and effluent was monitored at 254 nm. The mobile phase consisting of potassium dihydrogen phosphate [pH 5.8]: acetonitrile [HPLC Grade] (65:35 v/v). The flow rate was maintained at 0.9 mL/min. The calibration curve for metformin and sitagliptin was linear from 10.0 to 35.0 µg/mL (r2= 0.999) and 1.0 to 3.5 µg/mL (r2= 0.998) respectively. The inter-day and intra-day precision was found to be within limits. The lower limit of quantification (LLOQ) for metformin and sitagliptin were found to be 0.026 and 0.70 μg/mL respectively. The average % recovery for metformin and sitagliptin were found to be 98.82-100.03 & 99.76-100.89 % respectively and reproducibility was found to be satisfactory. This RP-HPLC method is suiTable for determining the concentration of metformin and sitagliptin in human plasma and it can applied for routine analysis for determination of the metformin and sitagliptin from dosage form during pharmacokinetic study.

A NEW BIOANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF TOLTERODINE TARTRATE IN HUMAN PLASMA BY USING RP-HPLC

INDIAN DRUGS ◽  
2015 ◽  
Vol 52 (07) ◽  
pp. 23-28
Author(s):  
S. A Kumar ◽  
◽  
M. Debnath ◽  
J. V. L. N. S. Rao ◽  
D. G Sankar
Keyword(s):  
Human Plasma ◽  
Mobile Phase ◽  
Method Development ◽  
Potassium Dihydrogen Phosphate ◽  
Precipitation Method ◽  
Dihydrogen Phosphate ◽  
Limit Of Quantification ◽  
Rp Hplc ◽  
Tolterodine Tartrate

A new RP-HPLC method was developed for the quantitative determination of tolterodine tartrate in human plasma and validated as per US-FDA guidelines. The drug was spiked in the plasma and extracted with the mobile phase by the precipitation method. The extracted analyte was injected into a Symmetry C18 (4.6 x 150mm, 5 μm, Make: Kromosil), maintained at 25°C and the effluent was monitored at 282 nm. The mobile phase consisted of potassium dihydrogen phosphate [pH 3.0]: acetonitrile [HPLC Grade] (50:50 V/V). The flow rate was maintained at 0.8 mL/min. The calibration curve for tolterodine tartrate was linear from 5.0 to 30.0 µg/mL (r2= 0.999). The inter-day and intra-day precision was found to be within the limits. The Lower Limit of Quantification (LLOQ) for tolterodine tartrate was found to be 0.35µg/mL. The average % recovery for tolterodine was 99.49-100.08% and reproducibility was found to be satisfactory. The proposed method has an adequate sensitivity, reproducibility, and specificity for the determination of tolterodine tartrate in human plasma.

scholarly journals RP-HPLC Method Development and Its Validation for Quantitative Determination of Rimonabant in Human Plasma

2012 ◽  
Vol 2012 ◽  
pp. 1-4 ◽  
Author(s):  
Shravan Bankey ◽  
Ganesh Tapadiya ◽  
Jasvant Lamale ◽  
Deepti Jain ◽  
Shweta Saboo ◽  
...  
Keyword(s):  
Human Plasma ◽  
Mobile Phase ◽  
Method Development ◽  
Bioequivalence Study ◽  
Hplc Method ◽  
Liquid Extraction ◽  
Liquid Liquid Extraction ◽  
Rp Hplc ◽  
Hplc Method Development

A simple, accurate, and precise HPLC method was developed and validated for determination of rimonabant in human plasma. Following liquid-liquid extraction, chromatographic separation was accomplished using C18 column with mobile phase consisting of acetonitrile : water (90 : 10, v/v), drug was detected at 260 nm using UVdetector. The LOD and LOQ were 3.0 and 10.0 μg/L, respectively. The method is linear in the interval 50.0–1000.0 μg/L. The average extraction recovery of drug from plasma was found to be 92.2%. The percent CV of the method was found to be less than 10.8%, and accuracy was found between 94.5 and 106.7%. The assay may be applied to a pharmacokinetic and bioequivalence study of rimonabant.

scholarly journals Development and Validation of a Simple RP-HPLC Method for Simultaneous Estimation of Metformin Hydrochloride and Rosiglitazone in Pharmaceutical Dosage Forms

2013 ◽  
Vol 11 (2) ◽  
pp. 157-163
Author(s):  
Md Akteruzzaman ◽  
Asma Rahman ◽  
Md Zakir Sultan ◽  
Farhana Islam ◽  
Md Abdus Salam ◽  
...  
Keyword(s):  
Reversed Phase ◽  
Dosage Forms ◽  
Hplc Method ◽  
Metformin Hydrochloride ◽  
Simultaneous Estimation ◽  
Dihydrogen Phosphate ◽  
Sodium Dihydrogen Phosphate ◽  
Pharmaceutical Dosage Forms ◽  
Rp Hplc

The objective of this study was to develop a simple, efficient, precise and accurate reversed phase HPLC (RP-HPLC) method for simultaneous determination of metformin in combination with rosiglitazone in newly formulated tablets. The combination of these drugs are commonly used and prescribed as anti-diabetic drugs in Bangladesh. The method has been developed by using the mobile phase comprising of sodium dihydrogen phosphate (NaH2PO4) buffer (pH 3.5) and acetonitrile (60:40, v/v) at a flow rate of 0.7 ml/min over C18 bonded silica column (ODS) (250 x 4.6 mm, 5 ?) at ambient temperature. The effluents were monitored at 230 nm and retention times were found to be 3.35 min and 11.95 min for metformin and rosiglitazone, respectively. Calibration curves were determined with a range from 0.03125 to 0.50 ?mole/ml of standards and the regression coefficients (r2) were found as 0.999 for metformin and 1.0 for rosiglitazone. The assay was validated for the accuracy, precision etc. according to ICH, USP and FDA guidelines. The proposed method can be useful in routine analysis for quantitative determination of metformin hydrochloride and rosiglitazone in pharmaceutical dosage forms. DOI: http://dx.doi.org/10.3329/dujps.v11i2.14574 Dhaka Univ. J. Pharm. Sci. 11(2): 157-163, 2012 (December)

ESTIMATION OF TINIDAZOLE IN ALBINO RAT PLASMA BY USING RP-HPLC

INDIAN DRUGS ◽  
2017 ◽  
Vol 54 (06) ◽  
pp. 48-52
Author(s):  
M. Debnath ◽  
◽  
Y. Indira Muzib ◽  
S. Ashutosh Kumar
Keyword(s):  
Mobile Phase ◽  
Potassium Dihydrogen Phosphate ◽  
High Specificity ◽  
Rat Plasma ◽  
Hplc Method ◽  
Precipitation Method ◽  
Dihydrogen Phosphate ◽  
Albino Rat ◽  
Rp Hplc

A new RP-HPLC method for the quantitative determination of tinidazole in albino rat plasma was developed and validated as per US-FDA guidelines. The drug was spiked in the albino rat plasma and extracted with mobile phase by precipitation method. The extracted analyte was injected into Hypersil ODS C 18 (4.6 x 150 mm; 5 μm) or equivalent, maintained at 25°C temperature and effluent monitored at 310 nm. The mobile phase consisted of potassium dihydrogen phosphate [pH 3.0]: acetonitrile [HPLC Grade] (40:60 v/v). The flow rate was maintained at 1.0 mL/min. The developed method shows high specificity for tinidazole. The calibration curve for tinidazole was linear from 1.0 to 40.0 ng/0.5mL plasma (r 2 = 1). The inter-day and intra-day precision was found to be within limits. The average % recovery for the drug tinidazole was found to be 99.53 - 100.21 % and the reproducibility was found to be satisfactory. The proposed method was adequate, sensitivity, reproducibility, and specificity for the determination of tinidazole in albino rat plasma.

Stability Indicating Assay Method Development and Validation of Simultaneous Estimation of Chlorzoxazone, Diclofenac Sodium and Paracetamol in Bulk Drug and Tablet by RP-HPLC

2021 ◽  
pp. 5024-5028
Author(s):  
Krutika Patel ◽  
Sudheer Kumar Verriboina ◽  
S.G. Vasantharaju
Keyword(s):  
Method Development ◽  
Diclofenac Sodium ◽  
Potassium Dihydrogen Phosphate ◽  
Hplc Method ◽  
Assay Method ◽  
Simultaneous Estimation ◽  
Dihydrogen Phosphate ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Bulk Drug

A simple, accurate, specific and stability-indicating RP-HPLC method was developed for simultaneous determination of chlorzoxazone, diclofenac sodium and paracetamol, using C18 Vydac Monomeric 120A (250 × 4.6mm, 5μ) at 40ºC. The mobile phase contains a mixture of 20mM potassium dihydrogen phosphate buffer (pH 6.2 adjusted with potassium hydroxide) and acetonitrile (30:70 v/v). The flow rate was 1ml/min and detection was carried out at 275nm using PDA detector. The retention time of paracetamol, chlorzoxazone and diclofenac sodium were 3.28mins, 13.27mins and 15.61mins respectively. The analytical curve was linear over a concentration range of 0.65- 6.5μg/ml for paracetamol, 1-10μg/ml for chlorzoxazone and 0.1-1μg/ml for diclofenac sodium. The drugs in bulk and tablet were subjected to acid and alkali hydrolysis, oxidation, thermal and photolytic degradation. This method can be successfully employed for simultaneous quantitative analysis of Chlorzoxazone, Diclofenac sodium and Paracetamol in bulk drug and tablet formulation.

scholarly journals Validation of developed method by RP-HPLC for simultaneous estimation of famotidine and ibuprofen in human plasma and studying the stability of the drugs in plasma

2018 ◽  
Vol 12 (1) ◽  
pp. 34-48
Author(s):  
K. S Ashutosh ◽  
D. Manidipa ◽  
R. J. V. L. N. Seshagiri ◽  
S. D. Gowri
Keyword(s):  
Human Plasma ◽  
Mobile Phase ◽  
Simultaneous Estimation ◽  
Hplc Separation ◽  
Reverse Phase ◽  
Rp Hplc ◽  
The Stability ◽  
Sodium Dihydrogen ◽  
Isocratic Mode

The RP-HPLC separation was carried out by reverse phase chromatography on a Symmetry C18 (4.6 x 150 mm, 3.5 μm, make: XTerra) with a mobile phase composed of sodium dihydrogen ortho phosphate [pH 2.5] and acetonitrile in the ratio of 30:70 v/v in an isocratic mode at a flow rate of 1.2 mL/min. The run time was maintained for 8.0 min. The detection was monitored at 236 nm. The accuracy was calculated in human plasma and the % recovery was found 99.80 - 99.85 for famotidine and 99.56 -99.85.5 for ibuprofen and reproducibility was found to be satisfactory. The calibration curve for famotidine in human plasma was linear over 3.32 to 6.65 μg/mL and 100- 200 μg/mL for ibuprofen in human plasma respectively. The inter-day and intra-day precision in human plasma was found within limits. The proposed method has adequate sensitivity, reproducibility, and specificity for the determination of famotidine and ibuprofen in plasma. The LLOQ obtained by the proposed method in human plasma were 1.24 and 5.0 μg/mL for famotidine and ibuprofen respectively. The proposed method is simple, fast, accurate, and precise for the quantification of famotidine and ibuprofen in plasma as per the ICH guidelines.Kathmandu University Journal of Science, Engineering and TechnologyVol. 12, No. I, June, 2016, Page: 34-48

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR THE SIMULTANEOUS DETERMINATION OF BERBERINE AND CURCUMIN IN AN AYURVEDIC FORMULATION

INDIAN DRUGS ◽  
2016 ◽  
Vol 53 (08) ◽  
pp. 48-52
Author(s):  
K. P Parekh ◽  
◽  
A. P. Jadhav
Keyword(s):  
Mobile Phase ◽  
Herbal Medicines ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Quality And Safety ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Water Ph ◽  
Development And Validation

A simple, accurate, precise, robust stability indicating RP-HPLC method was developed and validated for simultaneous estimation of berberine and curcumin in an ayurvedic formulation. The two markers were resolved using a C-18 column using as the mobile phase methanol: water (pH 3 adjusted using acetic acid) in the ratio 75:25 V/V at a flow rate of 1mL/min. Retention times of berberine and curcumin were 2.58 ± 0.2 min and 8.5 ± 0.2 min, respectively at 358 nm. Linear response was observed in the concentration range of 2 – 8 ppm for berberine and 5 – 40 ppm for curcumin, with correlation coefficient (r2) of 0.994 and 0.998 for berberine and curcumin, respectively. The developed method was applied for quantitation of markers in marketed and in-house formulations of Gruhadhoomadi Churna. This method can also be used to evaluate formulations containing berberine and curcumin as markers, thus conforming to the need of ensuring quality and safety of herbal medicines.

scholarly journals STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS DETERMINATION OF VILDAGLIPTIN AND METFORMIN IN PHARMACEUTICAL DOSAGE FORM

2017 ◽  
Vol 9 (3) ◽  
pp. 150
Author(s):  
Ramesh Jayaprakash ◽  
Senthil Kumar Natesan
Keyword(s):  
High Performance ◽  
Method Development ◽  
Limit Of Detection ◽  
Potassium Dihydrogen Phosphate ◽  
Hplc Method ◽  
Dihydrogen Phosphate ◽  
Pharmaceutical Dosage Form ◽  
Stability Indicating ◽  
Rp Hplc

Objective: The present study was aimed to develop a rapid, accurate, linear, sensitive and validate stability-indicating high performance liquid chromatographic [RP-HPLC] method for determination of vildagliptin and metformin in pharmaceutical dosage form.Methods: The chromatographic separation was performed on kromasil-C18 column [4.5 x 250 mm; 5 µm] using a mobile phase consisting of 0.05 mmol potassium dihydrogen phosphate buffer: acetonitrile [80:20 v/v], [pH adjusted to 3.5 using orthophosphoric acid]. The flow rate is 0.9 ml/min and the detection was carried out at 263 nm.Results: The chromatographic condition, the peak retention time of metformin and vildagliptin were found to be 2.215 min and 2.600 min respectively. Stress testing was performed in accordance with an international conference on harmonization [ICH] Q1A R2 guidelines. The method was validated as per ICH Q2 R1 guidelines. The calibration curve was found to be linear in the concentration range of 5-17.5 µg/ml and 50-175 µg/ml for vildagliptin and metformin. The limit of detection and quantification was found to be 0.0182 µg/ml and 0.0553 µg/ml for vildagliptin and 0.4451 µg/ml and 1.3490 µg/ml for metformin respectively.Conclusion: A new sensitive, simple and stability indicating reverse-phase high-performance liquid chromatography [RP-HPLC] method has been developed and validated for the determination of vildagliptin and metformin. The proposed method can be used for routine determination of vildagliptin and metformin.

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