scholarly journals Evolution and effectiveness of HPLC Technique for rapid estimation of an Antiallergenic agent Bilastine

2021 ◽  
pp. 57-62
Author(s):  
A. M. Beltagi ◽  
I. A. Lashin ◽  
W. A. Essa ◽  
A. A. Hathoot ◽  
M. Abdel Azzem
Keyword(s):  
Particle Size ◽  
Mobile Phase ◽  
Potassium Dihydrogen Phosphate ◽  
Calibration Plot ◽  
Dihydrogen Phosphate ◽  
Potassium Dihydrogen ◽  
Rapid Estimation ◽  
Rp Hplc ◽  
Stability Method ◽  
Hplc Technique

A new, simple, accurate, and specific RP-HPLC stability method for determining bilastine was developed and validated. The proposed method was administered using C18 BDS Hypersil thermo column (4.6 × 250mm i.d), 5 µm particle size with a combination of potassium dihydrogen phosphate buffer pH 6.0: acetonitrile: methanol (50:25:25) as the mobile phase at a wavelength of 220nm. The retention time was 3.9 min for bilastine. The calibration plot was linear over the concentration range of 14.4–33.6µg/ml bilastine with LOD and LOQ of 0.04 and 0.11µg/ml, respectively. The technique was validated for linearity, sensitivity, accuracy, precision, and robustness. Percent recoveries were observed to be nearly 100%. The validated method was used for determining bilastine in Pharmabilast(R) tablets. The technique could be appropriate for routine evaluation at laboratories.

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 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 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 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 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.

QUALITY BY DESIGN-BASED OPTIMIZATION AND VALIDATION OF NEW REVERSE PHASE-HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR SIMULTANEOUS ESTIMATION OF LEVOFLOXACIN HEMIHYDRATE AND AMBROXOL HYDROCHLORIDE IN BULK AND ITS PHARMACEUTICAL DOSAGE FORM

2016 ◽  
Vol 9 (9) ◽  
pp. 190
Author(s):  
Sumithra Sumithra ◽  
Shanmugasundaram P ◽  
Ravichandiran V
Keyword(s):  
High Performance ◽  
Quality By Design ◽  
Potassium Dihydrogen Phosphate ◽  
Simultaneous Estimation ◽  
Dihydrogen Phosphate ◽  
Reverse Phase ◽  
Pharmaceutical Dosage Form ◽  
Potassium Dihydrogen ◽  
Rp Hplc ◽  
Ambroxol Hydrochloride

ABSTRACTObjective: Innovative application of quality by design (QbD) technique for simultaneous estimation of levofloxacin and ambroxol hydrochloride (HCL)in bulk and its pharmaceutical dosage form using reverse phase-high-performance liquid chromatography (RP-HPLC) method.Method: A method has been developed for the separation of levofloxacin and ambroxol HCL using RP-HPLC on C18 column (250 4.6 mm, 5 ml) withultraviolet detection at 306 nm. Experimental designs were applied for multivariate optimization of the experimental conditions of RP-HPLC method.Three independent factors: Acetonitrile content in the mobile phase composition, buffer pH, and flow rate were used to design mathematical models.Here, central composite design (CCD) experimental design was used to study the response surface technique and to study in depth the effects ofthese independent factors. Derringer’s desirability function was applied to simultaneously optimize the retention time of last eluting peak (ambroxolhydrochloride) and resolution between levofloxacin and ambroxol hydrochloride.Result and Discussion: The predicted optimum assay condition consisted of acetonitrile, potassium dihydrogen phosphate buffer (pH 5.00;potassium dihydrogen phosphate), and methanol in a proportion of 20:70:10% v/v, respectively, as the mobile phase at a flow rate of 1.2 ml/minute.Using this optimum condition, baseline separation of both drugs with good resolution and a run time of <5 minutes were achieved. The optimizedassay condition was validated according to the ICH guidelines to confirm specificity, linearity, accuracy, and precision.Keywords: Levofloxacin, Ambroxol hydrochloride, Experimental design, Response surface methodology, Derringer’s desirability, Quality by designapproach.

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.

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.

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.

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