scholarly journals Development & Validation of HPLC method for simultaneous estimation of Drotaverine & Omeprazole

2020 ◽  
Vol 13 (1) ◽  
pp. 1-10
Author(s):  
Zaheer Shaikh ◽  
Abdul Ahad ◽  
Showkat Patel ◽  
Maqdoom Farooqui
Keyword(s):  
Potassium Dihydrogen Phosphate ◽  
Accurate Method ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Dihydrogen Phosphate ◽  
Good Precision ◽  
Potassium Dihydrogen ◽  
Steel Column ◽  
Stainless Steel Column ◽  
Precision And Accuracy

A simple and accurate method was developed for simultaneous estimation of Drotaverine & Omeprazole. The chromatography parameters includes stainless steel column Develosil ODS HG-5 RP C18, 5m, 15cmx4.6mm i.d and acetonitrile: potassium dihydrogen phosphate buffer (0.02M, pH 3.0) (55:45v/v) as mobile phase at a flow rate (1.0 ml/minute). The determinations were performed using UV-Vis detector set at 273 nm. The developed HPLC method showed specificity and selectivity with good precision and accuracy, which makes it very suitable for quantification of Drotaverine & Omeprazole.

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 Simultaneous Estimation of Diclofenac Sodium and Rabeprazole by High Performance Liqiud Chromatographic Method in Combined Dosage Forms

2009 ◽  
Vol 1 (01) ◽  
Author(s):  
Choudhary B. ◽  
Goyal A. ◽  
Khokra S. L. ◽  
Kaushik D.
Keyword(s):  
Mobile Phase ◽  
High Performance ◽  
Diclofenac Sodium ◽  
Potassium Dihydrogen Phosphate ◽  
Internal Standard ◽  
Dosage Forms ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Dihydrogen Phosphate ◽  
Potassium Dihydrogen

A simple, accurate and reproducible HPLC method have been developed for simultaneous estimation of Diclofenac sodium and rabeprazole from their tablets formulations. A phenomenex C18 (Luna) column of length 250×7.5 mm with particle size of the stationary phase 5 μm and S mobile phase potassium dihydrogen phosphate buffer (pH adjusted to 7.5 with 1 M sodium hydroxide) and acetonitrile in the ratio 60: 40 were used in this study. Retention time was found to be 9.20 min and 6.40 min for Rabeprazole and diclofenac sodium respectively. While that for internal standard as domperidone was 11.87 min at a flow rate of 2ml / min. Linearity was found in the concentration range of 10-50 μg /ml for both the drugs in this method. The results of analysis have been validated statistically and also by recovery studies.

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.

DEVELOPMENT AND VALIDATION OF LIQUID CHROMATOGRAPHIC METHOD FOR SIMULTANEOUS ESTIMATION OF STRYCHNINE AND GALLIC ACID

INDIAN DRUGS ◽  
2018 ◽  
Vol 55 (06) ◽  
pp. 46-50
Author(s):  
V. V. Khanvilkar ◽  
◽  
M Toraskar
Keyword(s):  
Gallic Acid ◽  
Potassium Dihydrogen Phosphate ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Dihydrogen Phosphate ◽  
Potassium Dihydrogen ◽  
Rp Hplc ◽  
Liquid Chromatographic Method ◽  
Development And Validation ◽  
Liquid Chromatographic

An accurate, precise and robust RP-HPLC method was developed for the simultaneous estimation of strychnine and gallic acid. The markers were resolved using HiQ C18HS column with methanol and potassium dihydrogen phosphate buffer (10 mM, pH 3) (60:40 V/V) as mobile phase at flow rate of 1 mL per minute and run time of 6 minutes. Retention times of strychnine and gallic acid were 3 and 4.7 minutes, respectively at 264 nm. The linearity range for strychnine and gallic acid was found to be 0.5-3 μg/mL and 1-3.5 µg/mL, respectively with coefficient of linear regression greater than 0.99 for both the markers. The developed method was validated as per ICH Q2 (R1) guidelines and the results obtained were satisfactory. The method was applied for quantification of markers in marketed and In-house formulations of Agnitundi Vati, a polyherbal ayurvedic formulation. The developed method thus could be used for standardization of Agnitundi Vati and other herbal preparations containing these two markers.

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 Simultaneous Volumetric and HPLC Methods for the Determination of Pridinol Mesylate in Raw Material

2013 ◽  
Vol 2013 ◽  
pp. 1-5
Author(s):  
Laura D. Simionato ◽  
Leonardo Ferello ◽  
Sebastián Stamer ◽  
Patricia D. Zubata ◽  
Adriana I. Segall
Keyword(s):  
Mobile Phase ◽  
Potassium Dihydrogen Phosphate ◽  
Hplc Method ◽  
Volumetric Method ◽  
Raw Material ◽  
Organic Layer ◽  
Dihydrogen Phosphate ◽  
Reverse Phase ◽  
Potassium Dihydrogen

Simple, sensitive, and economical simultaneous volumetric and HPLC methods for the determination of pridinol mesylate in raw material have been developed. The volumetric method is based on the reaction of pridinol with sodium lauryl sulphate in diluted sulphuric acid. Dimethyl yellow was used as indicator to detect the end point of the titration in aqueous/organic layer. The HPLC method for the determination of pridinol mesylate employs a reverse phase C18 column at ambient temperature with a mobile phase consisting of acetonitrile: 0.05 M potassium dihydrogen phosphate, pH adjusted to 5.0 (1 : 2, v/v). The flow rate was 0.8 mL/min. Quantitation was achieved with UV detection at 258 nm based on peak area. Both methods were found to be suitable for the quality control of pridinol mesylate in raw material.

scholarly journals The Determination of Metronidazole and Chlorhexidine Gluconate in Metronidazole and Chlorhexidine Lotion by HPLC

2022 ◽  
Vol 2152 (1) ◽  
pp. 012016
Author(s):  
Yun Yun ◽  
Mingshi Lin
Keyword(s):  
Potassium Dihydrogen Phosphate ◽  
Hplc Method ◽  
Chlorhexidine Gluconate ◽  
Dihydrogen Phosphate ◽  
Phosphate Solution ◽  
Phase Detection ◽  
Solution Ph ◽  
Tetrabutylammonium Hydroxide ◽  
Potassium Dihydrogen

Abstract Objective “To establish an HPLC method for the determination of metronidazole and chlorhexidine gluconate in metronidazole and chlorhexidine lotion. Method Using Agilent Eclipse-XDB-C18 chromatographic column, with 0.05 mol·L-1 potassium dihydrogen phosphate solution 1000 ml plus 13.2 ml 10% tetrabutylammonium hydroxide aqueous solution (pH adjusted to 3.5 by phosphoric acid)-acetonitrile (77:23) as Mobile phase, detection wavelength 230 nm. Results The two components could be separated well. The linear ranges of metronidazole and chlorhexidine acetate were 36.33~59.04 μg·ml-1 (r = 0.9994) and 35.45~220.11 μg·ml-1 (r = 1).); The average recoveries were 100.6% and 100.5 %, and the RSD were 0.42% and 0.58%. Conclusion: The method is simple and specific, and the result is more accurate and reliable. Which is suitable for simultaneous determination of two components in compound preparations.

scholarly journals Development of a high-performance liquid chromatography method for simultaneously analyzing Guanosine 5’-monophosphate (GMP) and Inosine 5’-monophosphate (IMP) in food

2021 ◽  
Vol 4 (4) ◽  
pp. 298-306
Author(s):  
Dinh Hai Le ◽  
Thu Nguyen Thi ◽  
Trang Vu Thi ◽  
Thuy Le Thi ◽  
◽  
...  
Keyword(s):  
High Performance ◽  
Potassium Dihydrogen Phosphate ◽  
Food Products ◽  
Hplc Method ◽  
Dihydrogen Phosphate ◽  
Food Matrix ◽  
Chromatography Method ◽  
Potassium Dihydrogen ◽  
Sample Preparation Procedure ◽  
Liquid Chromatography Method

This study aimed to develop a HPLC method to simultaneously analyze guanosine 5’-monophosphat (GMP) and inosine 5’-monophosphat (IMP) in food products. Sample preparation procedure was simple, fast. A C18 column (250 mm × 4.6 mm, 5 µm) was used as stationary phase, and a mixture of 10 mM potassium dihydrogen phosphate and 5 mM sodium heptanesulfonate was applied as mobile phase, and PDA detector at 250 nm. The method validation followed AOAC criteria. Selectivity, linearity (R2 > 0.999), recovery (IMP: 90.5 % - 102.8 %, GMP: 91.5 % - 103.9 %), repeatability (RSDR of IMP: 3.07 % and GMP: 2.83 %) were acceptable to determination GMP and IMP in food matrix under AOAC guidelines. LOD of GMP and IMP were of 2.32 and 2.77 mg/kg, respectively. This method was used to determination GMP, IMP in food products collected in Hanoi markets.

Validated Chromatographic Methods for the Simultaneous Estimation of Etamsylate and Mefenamic Acid in the Presence of Their Main Impurities

2019 ◽  
Vol 15 (6) ◽  
pp. 624-631
Author(s):  
Asmaa Ahmed El-Zaher ◽  
Marianne Alphonse Mahrouse ◽  
Ahmed Mohammed Al-Ghani
Keyword(s):  
Quality Control ◽  
Mefenamic Acid ◽  
Potassium Dihydrogen Phosphate ◽  
Hplc Method ◽  
Routine Analysis ◽  
Simultaneous Estimation ◽  
Dihydrogen Phosphate ◽  
Chromatographic Methods ◽  
Rp Hplc ◽  
Ich Guidelines

Background: Etamsylate (ETS), a haemostatic drug, is formulated with mefenamic acid (MFA) for pain relief. Objective: The aim of this work was to develop chromatographic methods for the estimation of ETS and MFA in the presence of their main impurities. These methods could be used in the routine analysis in quality control laboratories. Methods: The first method was RP-HPLC method, the separation was carried out on an Inertsil® ODS- 3V C18 column using a mobile phase composed of acetonitrile: potassium dihydrogen phosphate buffer adjusted to pH 7 with 0.1 N NaOH (55: 45, v/v) at a flow rate of 1 ml/ min. The detection was carried out at 220 nm. The second method was a TLC-densitometric method where the studied components were separated using a developing system composed of dichloromethane: ethyl acetate: methanol: triethylamine (6: 2: 2: 0.5, v/v/v/v) on TLC silica gel 60 F254 plates, followed by densitometric scanning at 300 nm. Results: In RP-HPLC method, the peaks were sharp and well separated, good retention times were obtained. Linearity was obtained over the concentration range 20-90 µg/ml, for both ETS and MFA. In the TLC-densitometric method, well separation of drug spots and linear relationship were achieved over the concentration range of 0.4-2.8 µg/spot, for both ETS and MFA. Method validation was conducted according to ICH guidelines. Conclusion: The developed methods were applied for the determination of the cited drugs in laboratory prepared mixtures and in tablets containing the two drugs. The methods are simple and precise and can be used for routine analysis of the drugs in combined dosage forms in quality control laboratories.

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