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 A New Stability Indicating RP-HPLC Method for Determination of Chlorthalidone, Telmisartan and Cilnidipine in Bulk and Tablet Dosage Form

2020 ◽  
Vol 13 (1) ◽  
pp. 44-51
Author(s):  
S.Afreen Sultana ◽  
Patta. Salomi ◽  
T. VimalakKannan ◽  
K.Ravindra Reddy
Keyword(s):  
Mobile Phase ◽  
Dosage Form ◽  
Potassium Dihydrogen Phosphate ◽  
Hplc Method ◽  
Dihydrogen Phosphate ◽  
Potassium Dihydrogen ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Tablet Dosage

In present study, accurate, precise, rapid and sensitive stability indicting HPLC-UV method has been established for quantification of Telmisartan, Cilnidipine and Chlorthalidone simultaneously in Tablet and bulk. Telmisartan, Cilnidipine and Chlorthalidone were resoluted on Sunsil C18 column (4.6mmx250mm; 5μm) using mobile phase containing Acetonitrile and Potassium dihydrogen phosphate in 50:50(v/v) ratio with flow rate of 1ml/min at 238 nm. Concentrations were linear over the range of 40-120 μg/ml for Telmisartan, 10-30 μg/ml for Cilnidipine and 6.25-18.75 μg/ml for Chlorthalidone. The percentage recovery was found to be 99.70-100.51% for Telmisartan, 98.41-100.49% for Cilnidipine and 99.34-100.48% for Chlorthalidone. % RSD for peak area was 0.069% for Telmisartan, 0.058% for Cilnidipine and 0.057% for Chlorthalidone shows that the proposed method is precise. Force-degradation studies have not shown any observable change in the results and hence the proposed method is stability indicating and hence the method is suitable for routine analysis of Telmisartan, Cilnidipine and Chlorthalidone in bulk and tablet dosage form.

scholarly journals HPLC METHOD FOR DETERMINATION OF FLUOROMETHOLONE AND SODIUM CROMOGLYCATE IN BULK AND OPHTHALMIC SOLUTION Authors

2015 ◽  
Vol 7 ◽  
pp. 1
Author(s):  
Hani M. Hafez ◽  
Keyword(s):  
Sodium Cromoglycate ◽  
Flow Rate ◽  
Mobile Phase ◽  
Allergic Conjunctivitis ◽  
Potassium Dihydrogen Phosphate ◽  
Ophthalmic Solution ◽  
Hplc Method ◽  
Dihydrogen Phosphate ◽  
Potassium Dihydrogen

Fluorometholone and Sodium Cromoglycate are used in the treatment of allergic conjunctivitis. A validated HPLC method was developed for the assay of them. The method was performed on BDS HYPERSIL C18 column (250x4.6 mm, 5μ) and the mobile phase consisted of potassium dihydrogen phosphate (pH 4.5, 0.025M) - Acetonitrile (40:60, V/V) which pumped at a flow rate 1.0 ml/min at ambient temperature. 20 µl of drugs sample solutions were monitored at two fixed wavelengths (lambda = 240.0 nm for Sodium Cromoglycate and 330.0 nm for Fluorometholone). The proposed method was validated in terms of linearity, accuracy, precision and limits of detection and quantitation according to ICH

scholarly journals Simultaneous Determination of Matrine and Tinidazole in Compound Lotion by RH-HPLC Method

2013 ◽  
Vol 2013 ◽  
pp. 1-5 ◽  
Author(s):  
Zhikui Yin ◽  
Suying Ma ◽  
Jincai Wang ◽  
Xiaojun Shang
Keyword(s):  
Simultaneous Determination ◽  
Mobile Phase ◽  
Potassium Dihydrogen Phosphate ◽  
Hplc Method ◽  
Dihydrogen Phosphate ◽  
Uv Detector ◽  
Potassium Dihydrogen ◽  
Rp Hplc ◽  
Detector Method

A simple, sensitive, and accurate RP-HPLC coupled with UV detector method was developed and validated for simultaneous determination of matrine and tinidazole in compound lotion. The chromatographic separation of the two compounds was carried out with a SinoChoom ODS-BP C18column (5 μm, 4.6 mm × 200 mm) analytical column, using a mobile phase consisting of 0.025 mol/L potassium dihydrogen phosphate (containing triethylamine 0.05%, v/v) and acetonitrile (80 : 20, v/v) at a flow rate of 1.0 mL/min. The detection was monitored at 210 and 310 nm for matrine and tinidazole, respectively. Total run time was 12 min, and the column was maintained at 25°C. The excipients in the compound lotion did not interfere with the drug peaks. The calibration curves of matrine and tinidazole were fairly linear over the concentration ranges of 10.0–100.0 μg/mL (r=0.9954) and 20.0–200.0 μg/mL (r=0.9968), respectively. The RSD of both the intraday and interday variations was below 1.5% for matrine and tinidazole. The proposed HPLC method was validated according to International Conference on Harmonisation and proved to be suitable for the simultaneous determination of matrine and tinidazole in compound lotion.

scholarly journals Different Stability-Indicating Chromatographic Techniques for the Determination of Netobimin

2012 ◽  
Vol 2012 ◽  
pp. 1-8
Author(s):  
Nesrin K. Ramadan ◽  
Afaf O. Mohamed ◽  
Sara E. Shawky ◽  
Maissa Y. Salem
Keyword(s):  
Degradation Product ◽  
Mobile Phase ◽  
Potassium Dihydrogen Phosphate ◽  
Ammonium Hydroxide ◽  
Hplc Method ◽  
Dihydrogen Phosphate ◽  
Potassium Dihydrogen ◽  
Product Method ◽  
The Mean

Two simple, accurate, and sensitive methods were developed for the determination of netobimin in the presence of its degradation product. Method (A) was an HPLC method, performed on C18 column using acetonitrile/methanol/0.01 M potassium dihydrogen phosphate (56 : 14 : 30 by volume) as a mobile phase with a flow rate of 0.5 mL/min. Detection was performed at 254 nm. Method (B) was a TLC method, using silica gel 60 F254plates; the optimized mobile phase was toluene/methanol/chloroform/ammonium hydroxide (5 : 4 : 6 : 0.1 by volume). The spots were scanned densitometrically at 346 nm. Linearity ranges were 1–10 μg/mL for method (A) and 0.5–5 μg/band for method (B), and the mean percentage recoveries were99.3±0.7% and99.7±0.7% for methods (A) and (B), respectively. The proposed methods were found to be specific for netobimin in the presence of up to 90% of its degradation product. Statistical comparison between the results obtained by these methods and the manufacturer method was done, and no significance difference was obtained.

scholarly journals Development and validation of a reversed-phase HPLC method for determination of assay content of Teriflunomide by the aid of BOMD simulations

2021 ◽  
pp. 281-294 ◽  
Author(s):  
Abolghasem Beheshti ◽  
Zahra Kamalzadeha ◽  
Monireh Haj-Maleka ◽  
Meghdad Payaba ◽  
Mohammad Amin Rezvanfar ◽  
...  
Keyword(s):  
Mobile Phase ◽  
Potassium Dihydrogen Phosphate ◽  
Active Pharmaceutical Ingredient ◽  
Reversed Phase ◽  
Hplc Method ◽  
Dihydrogen Phosphate ◽  
Td Dft ◽  
High Level ◽  
Development And Validation

Due to the new hopes for treatment of multiple sclerosis (MS) diseases by Teriflunomide (TFN), in this project, a cheap, robust, and fully validated method has been developed both for determination of assay content in API (active pharmaceutical ingredient), and for related impurities analysis (RIA). To operate the method, a common C18, end-capped (250 × 4.6) mm, 5µm liquid chromatography column, was applied. The mobile phase A was prepared by dissolving 2.74 g (20mM) of PDP (potassium dihydrogen phosphate) and 3.72 g (50mM) of PC (potassium chloride) in water (1000 mL). Then, pH was adjusted to 3.0 by adding OPA (ortho-phosphoric acid) 85%; while, the mobile phase B was acetonitrile (ACN) (100%). In order to confirm the experimental data about the λmax of TFN, we have used the Born-Oppenheimer molecular dynamics (BOMD) simulations, quantum mechanics (QM), and TD-DFT calculations. According to the results, the method showed a high level of suitability, specificity, linearity, accuracy, precision, repeatability, robustness, and reliable detection limit.

scholarly journals Simultaneous HPLC Determination of Chlordiazepoxide and Mebeverine HCl in the Presence of Their Degradation Products and Impurities

2015 ◽  
Vol 2015 ◽  
pp. 1-9
Author(s):  
Rania N. El-Shaheny ◽  
Fathalla F. Belal
Keyword(s):  
Simultaneous Determination ◽  
Degradation Product ◽  
Mobile Phase ◽  
Degradation Products ◽  
Potassium Dihydrogen Phosphate ◽  
Hplc Method ◽  
Dihydrogen Phosphate ◽  
Ir Studies ◽  
Validation Procedure

A simple, rapid, and sensitive RP-HPLC method was developed and validated for the simultaneous determination of chlordiazepoxide (CDO) and mebeverine HCl (MBV) in the presence of CDO impurity (2-amino-5-chlorobenzophenone, ACB) and MBV degradation product (veratric acid, VER). Separation was achieved within 9 min on a BDS Hypersil phenyl column (4.5 mm × 250 mm, 5 µm particle size) using a mobile phase consisting of acetonitrile: 0.1 M potassium dihydrogen phosphate: triethylamine (35 : 65 : 0.2, v/v/v) in an isocratic mode at a flow rate of 1 mL/min. The pH of the mobile phase was adjusted to 4.5 with orthophosphoric acid and UV detection was set at 260 nm. A complete validation procedure was conducted. The proposed method exhibited excellent linearity over the concentration ranges of 1.0–100.0, 10.0–200.0, 2.0–40.0, and 2.0–40.0 µg/mL for CDO, MBV, VER, and ACB, respectively. The proposed method was applied for the simultaneous determination of CDO and MBV in their coformulated tablets with mean percentage recoveries of 99.75 ± 0.62 and 98.61 ± 0.38, respectively. The results of the proposed method were favorably compared with those of a comparison HPLC method using Studentt-test and the variance ratioF-test. The chemical structure of MBV degradation product was ascertained by mass spectrometry and IR studies.

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.

A Validated HPLC Method for Simultaneous Determination of Perindopril Arginine, Amlodipine, and Indapamide: Application in Bulk and in Different Pharmaceutical Dosage Forms

2017 ◽  
Vol 100 (4) ◽  
pp. 992-999 ◽  
Author(s):  
Ramzia I El-Bagary ◽  
Ehab F Elkady ◽  
Shereen Mowaka ◽  
Maria A Attallah
Keyword(s):  
Potassium Dihydrogen Phosphate ◽  
Pharmaceutical Preparations ◽  
Dosage Forms ◽  
Hplc Method ◽  
Dihydrogen Phosphate ◽  
Pharmaceutical Dosage Forms ◽  
Potassium Dihydrogen ◽  
Accuracy And Precision ◽  
Significant Difference

Abstract A simple, accurate, and precise LC method with a reversed stationary phase was developed and validated for the determination of perindopril (PER) arginine, amlodipine (AML), and indapamide (IND) alone and in binary mixtures (PER arginine is found in two dosage forms, i.e., with either AML or IND). Chromatographic separation was carried out on a BDS Hypersil® C18 column (100 × 3 mm, 5 μm). The mobile phase, consisting of 0.05 M potassium dihydrogen phosphate buffer (pH 2.6)–methanol (50 + 50, v/v), was pumped through the column whose temperature was maintained at 50°C at a flow rate of 0.6 mL/min using isocratic elution, and UV detection at 215 nm was performed. Acceptable values of linearity, accuracy, and precision of the method were found over the concentration ranges of 5–80 μg/mL PER, 2.5–80 μg/mL AML, and 0.5–20 μg/mL IND. The proposed chromatographic method was statistically compared to that of reference methods using one-way analysis of variance. The results showed that there was no significant difference between the methods. The developed method proved reliable for use in accurate QC of the drugs in their pharmaceutical preparations.

scholarly journals Analisis Beberapa Asam Organik dengan Metode High Performance Liquid Chromatography (HPLC) Grace Smart Rp 18 5µ

Jurnal MIPA ◽  
2015 ◽  
Vol 4 (2) ◽  
pp. 148
Author(s):  
Lungguk Sitorus ◽  
Julius Pontoh ◽  
Vanda Kamu
Keyword(s):  
Ascorbic Acid ◽  
High Performance Liquid Chromatography ◽  
Acetic Acid ◽  
Mobile Phase ◽  
High Performance ◽  
Potassium Dihydrogen Phosphate ◽  
Hplc Method ◽  
Dihydrogen Phosphate ◽  
Column Temperature ◽  
Potassium Dihydrogen

Metode HPLC fase terbalik dengan kolom Grace Smart RP 18 5µ dapat digunakan untuk memisahkan dan menentukan konsentrasi asam-asam organik. Metode ini diaplikasikan suhu kolom 40 oC dan dideteksi pada panjang gelombang 210 nm dengan kalium dihidrogenfosfat (pH 2,8) sebagai fase gerak. Metode ini telah digunakan untuk menentukan asam-asam organik seperti asam malat, asam askorbat, asam laktat, asam asetat, asam sitrat, asam piroglutamat, dan asam fumarat.Reverse phase HPLC method using Grace smart RP 18 5µ can used to separating and calculating concentration of organic acid. This method did on 40 0C column temperature and detected on wavelength 210 nm with potassium dihydrogen phosphate (pH 2.8) as mobile phase. Determining of organic acids such as malic acid, ascorbic acid, lactic acid, acetic acid, citric acid, pyroglutamic acid and fumaric acid.

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.

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