scholarly journals A Highly Validated RP-HPLC Method Development for the Simultaneous Estimation of Dapagliflozin and Saxagliptin in Tablet Dosage Forms

2018 ◽  
Vol 10 (05) ◽  
Author(s):  
B. Sivagami ◽  
B. Reddy Padmaja ◽  
M. Niranjan Babu
Keyword(s):  
Method Development ◽  
Potassium Dihydrogen Phosphate ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Dihydrogen Phosphate ◽  
Regression Equations ◽  
Column Temperature ◽  
Potassium Dihydrogen ◽  
Hplc Method Development ◽  
Tablet Dosage

A simple, accurate, precise method was developed for the simultaneous estimation of Dapagliflozin and Saxagliptin in Tablet dosage form. Chromatogram was run through Standard BDS C8 column (50 × 4.6 mm, 5) The Mobile phase containing Potassium dihydrogen phosphate: Acetonitrile in the ratio 55:45, pH was adjusted to 3.8 with dilute orthophosphoric acid. The solution was pumped through the column at a flow rate of 1 ml/min. The column temperature was maintained at 30°C. Optimized wavelength selected was 210 nm. Retention time of Dapagliflozin and Saxagliptin were found to be 2.266 min and 2.805 min. % RSD of the Dapagliflozin and Saxagliptin were found to be 0.5 and 0.5 respectively. % Recovery was obtained as 98.98% and 98.72% for Dapagliflozin and Saxagliptin respectively. LOD, LOQ values obtained from regression equations of Dapagliflozin and Saxagliptin were 0.20, 0.60 and 0.26, 0.79 respectively. Regression equation of Dapagliflozin is y = 37377x + 89244, and y =12254x + 3122 of Saxagliptin. The retention times were decreased so that the run time also decreased. So the method developed was simple and economical that can be applied successfully for simultaneous estimation of both Dapagliflozin and Saxagliptin in bulk and combined tablet formulation.

Validation of RP-HPLC Method for Simultaneous Estimation of Cefixime Trihydrate and Clavulanate Potassium in Tablets

2013 ◽  
Vol 6 (2) ◽  
pp. 2033-2039
Author(s):  
S.S. Zade ◽  
Bhatpalliwar V.B ◽  
N S Mendhule ◽  
M V Murkhekar ◽  
R S Alaspure ◽  
...  
Keyword(s):  
Method Development ◽  
Potassium Dihydrogen Phosphate ◽  
Correlation Coefficients ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Dihydrogen Phosphate ◽  
Ich Guidelines ◽  
Optimum Wavelength ◽  
Hplc Method Development ◽  
Tablet Dosage

A simple, accurate, precise, rapid and economic HPLC method has been developed and validated for the simultaneous estimation of cefixime trihydrate and clavulanate potassium in tablet dosage forms. The chromatographic separation was achieved on a Hypersil C18 column (4.6 x 250 mm, 5 μm particle size). For HPLC method development, a mobile phase consisting of methanol: 30 mM potassium dihydrogen phosphate buffer pH 3.0 adjusted with orthophosphoric acid (30:70 v/v) was used at flow rate of 1.0 ml/min. The optimum wavelength selected was 278 nm. Under these chromatographic conditions, cefixime trihydrate and clavulanate potassium peaks were well resolved, with retention times of cefixime trihydrate and clavulanate potassium being 5.8266 and 3.2633 min, respectively. The proposed method was found to have excellent linearity in the concentration range 20-100 μg/ml with correlation coefficients r2 = 0.9946 and 0.9926, respectively. The method was validated for linearity, precision, LOD, LOQ and robustness. The proposed method was optimized and validated as per the ICH guidelines.

scholarly journals Stability indicating RP-HPLC method development and validation for the simultaneous estimation of Grazoprevir and Elbasvir in bulk and pharmaceutical dosage form

2018 ◽  
Vol 1 (1) ◽  
pp. 1-7
Author(s):  
V. Pavan Kumar ◽  
A. Vijaya Kumar ◽  
B Sivagami ◽  
R. Charan Kumar ◽  
M. Niranjan Babu
Keyword(s):  
Dosage Form ◽  
Method Development ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Regression Equations ◽  
Pharmaceutical Dosage Form ◽  
Potassium Hydrogen ◽  
Hplc Method Development ◽  
Development And Validation ◽  
Tablet Dosage

A simple, Accurate and precise method was developed for the simultaneous estimation of the Grazoprevir and Elbasvir in Tablet dosage form. Chromatogram was run through Kromosil C18 (250 x 4.6 mm), 5m. Mobile phase containing Buffer: Acetonitrile taken in the ratio 45:55 was pumped through column at a flow rate of 1 ml/min. Buffer used in this method was Di Potassium Hydrogen ortho Phosphate. Temperature was maintained at 30°C. Optimized wavelength selected was 215 nm. Retention time of Elbasvir and Grazoprevir and were found to be 2.503 min and 3.004. %RSD of the Elbasvir and Grazoprevir were and found to be 0.3 and 0.4 respectively. %Recovery was obtained as 98.17% and 99.83% for Grazoprevir and Elbasvir respectively. LOD, LOQ values obtained from regression equations of Grazoprevir and Elbasvir were 0.24, 0.73 and 0.06, 0.19 respectively. Retention times were decreased and run time was decreased, so the method developed was simple and economical that can be adopted in regular Quality control test in Industries.

scholarly journals Development and Validation of RP-HPLC Method for Estimation of Teneligliptin and its Impurity in Tablet

2021 ◽  
Vol 69 (02) ◽  
Author(s):  
Bhoomi Dineshkumar Patel ◽  
Nidhi J. Dharsandiya ◽  
Ankit Chaudhary
Keyword(s):  
Present Method ◽  
Mobile Phase ◽  
Potassium Dihydrogen Phosphate ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Dihydrogen Phosphate ◽  
Potassium Dihydrogen ◽  
Rp Hplc ◽  
Development And Validation ◽  
Tablet Dosage

The objective of the study is a simple, precise and accurate stability RP-HPLC method has been developed and subsequently validated for the estimation of Teneligliptin and its impurity in tablet formulation. The adequate separation was carried out using Grace Smart C18 column (250mm x 4.6mm, 5?m particle size), mixture of 0.05M Potassium dihydrogen phosphate PH 4.0 and Acetonitrile 80:20 % v/v as a mobile phase with a flow rate of 1 ml/min and the effluent was monitored at 242 nm using PDA detector. The retention time of Teneligliptin, Impurity B and Impurity G were 7.443 min, 6.650 min and 8.473 min respectively. Linearity for Teneligliptin, Impurity B and Impurity G were found in the range of 500-3000 µg/ml (R2 = 0.998), 5-15 µg/ml (R2 = 0.994) and 5-15 µg/ml (R2 = 0.998) respectively. The accuracy of the present method was evaluated at 50%, 100% and 150%. The % recoveries of drug were found to be in range of 99.315 ± 0.283 for Teneligliptin. Precision studies were carried out and the RSD values were less than two. The method was found to be robust. The proposed method was found to be specific, accurate, precise and robust can be used for simultaneous estimation of these drugs in tablet dosage form.

scholarly journals Validated stability-indicating RP-HPLC method for simultaneous estimation of cilnidipine and chlorthalidone in tablet dosage form

2020 ◽  
Vol 11 (SPL4) ◽  
pp. 2435-2441
Author(s):  
Ashok B. Patel ◽  
Amitkumar J. Vyas ◽  
Shital Faldu ◽  
Arvind N Lumbhani ◽  
Nikunj J. Patel ◽  
...  
Keyword(s):  
Phosphoric Acid ◽  
Dosage Form ◽  
Potassium Dihydrogen Phosphate ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Dihydrogen Phosphate ◽  
Potassium Dihydrogen ◽  
Rp Hplc ◽  
Tablet Dosage ◽  
Ich Guideline

A novel, simple, specific, accurate & precise stability-indicating Gradient reverse-phase high-performance liquid chromatography (RP-HPLC) method was developed for simultaneous estimation of Cilnidipine & Chlorthalidone in tablet dosage form, validated as per ICH guideline. The separation was achieved on Inertsil ODS column (250 mm x 4.6 mm, 5 μm) in a gradient mode.  The mobile phase consisted of Methanol, 0.025 M Potassium dihydrogen phosphate Buffer pH 5.5 adjusted by 10% v/v Ortho Phosphoric Acid (50:50 v/v) (Solution A) and Acetonitrile, 0.025 M Potassium dihydrogen phosphate Buffer pH 5.5 adjusted by 10%v/v Ortho Phosphoric Acid (75:25 v/v) (Solution B), gradient programming for 20 min at 1 ml/min rate of flow and response was detected at 225 nm. The retention time was found to be 3.580 min and 12.606 mins for Chlorthalidone and Cilnidipine, respectively. The method is validated according to ICH guideline, which includes linearity, specificity, accuracy, precision and robustness. Linearity was obtained over the concentration range of 10-60 μg/ml for Cilnidipine and 6.25-37.5 μg/ml for Chlorthalidone, had a regression coefficient (r2) almost 0.9966. The % Recovery was found to be 99.63-100.59 % and 100.24-100.51 % for Cilnidipine and Chlorthalidone, respectively. The method was found to be specific enough to separate all degradation products from the active compound. Drug samples were exposed to various stress conditions like photolysis, oxidation, heat conditions, and hydrolysis (acidic and alkaline), there was no interference of any degradants and excipient in the determination of drugs so that methods can be successfully applied for routine QC analysis.

scholarly journals Stability indicating RP-HPLC method development and validation for the simultaneous determination of Sofosbuvir and Velpatasvir in tablet dosage forms

2017 ◽  
Vol 5 (04) ◽  
pp. 10-16 ◽  
Author(s):  
Jahnavi Bandla ◽  
S. Ganapaty
Keyword(s):  
Mobile Phase ◽  
Method Development ◽  
Potassium Dihydrogen Phosphate ◽  
Hplc Method ◽  
Dihydrogen Phosphate ◽  
Pharmaceutical Dosage Form ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Hplc Method Development ◽  
Tablet Dosage

Stability indicating RP-HPLC method was developed for the simultaneous quantitation of Sofosbuvir and Velpatasvir in its pharmaceutical dosage form and validated. The drugs were separated on Discovery C18 (150mm x 4.6mm, 5μ) column using 0.01N potassium dihydrogen phosphate buffer and acetonitrile (50:50%v/v) as mobile phase on isocratic mode. The mobile phase is pump into the column at flow rate of 1.0ml/min and column oven temperature is maintained at 30ºC. The drugs were detected at a wavelength 240nm. The retention time for Sofosbuvir and Velpatasvir were found to be 2.32min and 3.34min respectively. The developed method is validated in accordance with ICH guidelines. The method was found to be accurate, precise, specific and robust. The method obeys Beer’s law at a concentration range of 100μg/ml – 600μg/ml of Sofosbuvir and 25μg/ml – 150μg/ml of Velpatasvir, with correlation coefficient of 0.999 for both the drugs. The drugs were found to be stable and less prone to degradation when they are subjected to various stress conditions.

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 RP-HPLC Method Development and Validation for the Estimation of Mirabegron in Bulk and Dosage Form

2020 ◽  
Vol 10 (1) ◽  
pp. 31-38
Author(s):  
Rahul Suryawanshi ◽  
Siddiqua Shaikh ◽  
Snehal Patil
Keyword(s):  
High Performance ◽  
Method Development ◽  
Limit Of Detection ◽  
Pharmaceutical Formulations ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Limit Of Quantification ◽  
Rp Hplc ◽  
Hplc Method Development ◽  
Tablet Dosage

A new, simple, precise, accurate and reproducible Reverse Phase High Performance Liquid Chromatography (RP-HPLC) method for Simultaneous estimation of bulk and pharmaceutical formulations. Separation of Mirabegron was successfully achieve , C18, 250X4.6mm, 5µm or equivalent in an isocratic mode utilizing methanol water (70:30) at pH 5.0 Adjusted to OPA at a flow rate of 1.0ml/min and eluate was monitored at 243nm, with a retention time of 2.584 minutes for Mirabegron. The method was validated and the response was found to be linear in the drug concentration range of 50µg/ml to150 µg/ml for Mirabegron. The values of the correlation coefficient were found to 0.999for Mirabegron. The Limit of Detection(LOD) and Limit of Quantification (LOQ) for Mirabegron were found to be 0.149 and 0.498 respectively. This method was found to be good percentage recovery were found to be 99 indicates that the proposed method is highly accurate. The specificity of the method shows good correlation between retention times of standard with the sample so, the method specifically determines the analyte in the sample without interference from excipients of tablet dosage forms. The method was extensively validated according to International Council for Harmonisation(ICH) guidelines for Linearity, Accuracy, Precision, Specificity and

RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF TENELIGLIPTINE HYDROBROMIDE HYDRATE (TEN) AND METFORMIN HYDROCHLORIDE (MET) IN TABLET DOSAGE FORM

INDIAN DRUGS ◽  
2019 ◽  
Vol 56 (08) ◽  
pp. 49-56
Author(s):  
H Joshi ◽  
A. Khristi ◽  
Keyword(s):  
Dosage Form ◽  
Method Development ◽  
Hplc Method ◽  
Assay Method ◽  
Metformin Hydrochloride ◽  
Simultaneous Estimation ◽  
Pharmaceutical Dosage Form ◽  
Economic Method ◽  
Hplc Method Development ◽  
Tablet Dosage

A simple, accurate, precise, reproducible and economic method developed and validated for the simultaneous estimation of teneligliptine hydrobromide hydrate (TENE) and metformin hydrochloride (MET HCl) in pharmaceutical dosage form. TENE and MET HCl were estimated on Thermoscientific C18 column using mobile phase 0.01M PDP: methanol (45:55 % v/v) (pH 3.5 adjusted with 5% acetic acid) at flow rate 1.0 mL/min. Detection was carried out at 254 nm. The retention time of teneligliptine hydrobromide hydrate and metformin hydrochloride were 7.77 min and 2.64 min, respectively. The linearity was found to be 4-12 μg/mL and 100-300 μg/mL for TENE and MET HCl respectively. R2 value was found to be 0.998 and 0.995. For the assay method % recovery was found in the range of 98.16 – 101 for TENE and MET HCl. The LOD and LOQ were found to be 0.3527 and 1.0690 for TENE and 0.5077 and 1.538 for MET HCl respectively. Method was validated as per ICH guidelines.

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