scholarly journals DETERMINATION AND VALIDATION OF MEBHYDROLINE NAPADISYLATE IN TABLETS BY HPLC

2010 ◽  
Vol 8 (3) ◽  
pp. 377-379 ◽  
Author(s):  
Lestyo Wulandari
Keyword(s):  
Quality Control ◽  
Ambient Temperature ◽  
Mobile Phase ◽  
Pharmaceutical Preparation ◽  
Reversed Phase ◽  
Hplc Method ◽  
Uv Detection ◽  
Analysis Time ◽  
Routine Analysis

An accurate and sensitive HPLC method has been developed for the determination of mebhydroline napadisylate in the tablet. The Chromatography was performed on a reversed phase C-18 column, using a mobile phase of acetonitrile : ammonia 25% (80 : 20 v/v) at ambient temperature 25±5 °C and UV detection operates at 320 nm in an overall analysis time of about 15 min, based on peak area. This HPLC method is selective, precise, and accurate and can be used for routine analysis of pharmaceutical preparation in industrial quality-control laboratories.   Keywords : HPLC, mebhydroline napadisylate, validation

scholarly journals LC Determination and Stability Assessment of Macrolide Antibiotics Azithromycin and Spiramycin in Bulk and Tablet Samples

2015 ◽  
Vol 47 ◽  
pp. 1-10 ◽  
Author(s):  
A. Mahmoudi
Keyword(s):  
Detection Limit ◽  
Ambient Temperature ◽  
Flow Rate ◽  
Mobile Phase ◽  
Reversed Phase ◽  
Hplc Method ◽  
Uv Detection ◽  
Macrolide Antibiotics ◽  
Stability Assessment ◽  
Development And Validation

Development and validation of rapid HPLC method for quantifying macrolide antibiotics azithromycin (AZI) and spiramycin (SPI) in bulk and tablet samples is described. Determination was performed on a reversed phase C18 ODB column (250×4.6 nm I.D) at ambient temperature, and employing a UV-detection set at 210 nm. The mobile phase consists of acetonitrile –2-methyl-2-propanol–hydrogenphosphate buffer, pH 6.2, with 1.8% triethylamine (32:8: up to 100, v/v/v), delivered at a flow-rate of 1.1 mL min-1. The assay is linear in concentration ranges of: 0.004–4.8 and 0.0003–1.2 mg mL−1 for azithromycin and spiramycin, respectively, with detection limit of 0.02% for SPI and 0.03% for AZI. Recovery experiments revealed recovery of 98.51–100.82%. The applicability of this method in stability assessment studies is evaluated.

scholarly journals Development of an Ion-Pair Reversed-Phase HPLC Method with Indirect UV Detection for Determination of Phosphates and Phosphites as Impurities in Sodium Risedronate

2010 ◽  
Vol 93 (4) ◽  
pp. 1113-1120
Author(s):  
Katerina Brezovska ◽  
Aneta Dimitrovska ◽  
Zoran Kitanovski ◽  
Jelena Petrusevska ◽  
Jasmina Tonic Ribarska ◽  
...  
Keyword(s):  
Mobile Phase ◽  
Reversed Phase ◽  
Hplc Method ◽  
Uv Detection ◽  
Tetrabutylammonium Hydroxide ◽  
Indirect Uv Detection ◽  
High Background ◽  
Potassium Hydrogen ◽  
Background Absorption

Abstract A method based on RP-HPLC with indirect UV detection was developed for the determination of phosphates and phosphites as impurities in sodium risedronate. RP separation of the phosphates and phosphites was achieved by adding tetrabutylammonium hydroxide as an ion-pairing agent in the mobile phase. Potassium hydrogen phthalate was added to the mobile phase as an ionic chromophore in order to obtain high background absorption of the mobile phase. Separation was performed on a C18 column using a mixture of pH 8.2 buffer (containing 0.5 mM tetrabutylammonium hydroxide and 1 mM phthalate) and acetonitrile (95 + 5, v/v) as the mobile phase, with indirect UV detection at 248 nm. The validation of the method included determination of specificity/selectivity, linearity, LOD, LOQ, accuracy, precision, and robustness. The LOD was 0.86 g/mL for phosphates and 0.76 g/mL for phosphites. The LOQ was 2.60 g/mL for phosphates and 2.29 g/mL for phosphites. The developed method is suitable for quantitative determination of phosphates and phosphites as impurities in QC of sodium risedronate.

scholarly journals Validation of UV Spectrophotometric and HPLC Methods for Quantitative Determination of Chlorpyrifos

2013 ◽  
Vol 21 ◽  
pp. 58-63
Author(s):  
O.A. Zalat ◽  
Mohamed A. Elsayed ◽  
M.S. Fayed ◽  
M.K. Abd El Megid
Keyword(s):  
Quality Control ◽  
Statistical Analysis ◽  
Spectrophotometric Method ◽  
Mobile Phase ◽  
Reversed Phase ◽  
Hplc Method ◽  
Routine Quality Control ◽  
Phase Column ◽  
Reversed Phase Column

A specific and sensitive HPLC and UV spectrophotometric methodwere developed for determination and analysis of chlorpyrifos. Chromatographic separation was achieved on a 150 mm x 10 mm I.D. reversed phase column Zorbax SB C-18. usingdeionizedwater: acetonitrile in the ratio of 10:90 v/v respectively as mobile phase. The effluent was monitored at 290 and 230 nm. Two sharp peaks were obtained for the solvent and chlorpyrifos at 2.7 and 3.45 min respectively. UV spectrophotometric method was performed at 290 nm using Isopropanol as the solvent. Linear range was 0.025-3500 ppm (r2 = 0.9986 ±0.0009) for HPLC method and 2.229 to 200 ppm (r2 = 0.9988) for UV spectrophotometric method. Validation guidelines and statistical analysis showed that both the methods were precise, accurate, sensitive, and can be used for the routine quality control of chlorpyrifos in waste discharges

scholarly journals Simultaneous Determination of Preservatives (Methyl Paraben and Propyl Paraben) in Sucralfate Suspension Using High Performance Liquid Chromatography

2011 ◽  
Vol 8 (1) ◽  
pp. 340-346 ◽  
Author(s):  
Rajesh M. Kashid ◽  
Santosh G. Singh ◽  
Shrawan Singh
Keyword(s):  
High Performance Liquid Chromatography ◽  
Simultaneous Determination ◽  
Mobile Phase ◽  
High Performance ◽  
Reversed Phase ◽  
Hplc Method ◽  
Reversed Phase Hplc ◽  
Methyl Paraben ◽  
Propyl Paraben

A reversed phase HPLC method that allows the separation and simultaneous determination of the preservatives methyl paraben (M.P.) and propyl paraben (P.P.) is described. The separations were effected by using an initial mobile phase of water: acetonitrile (50:50) on Inertsil C18 to elute P.P. and M.P. The detector wavelength was set at 205 nm. Under these conditions, separation of the two components was achieved in less than 10 min. Analytical characteristics of the separation such as precision, specificity, linear range and reproducibility were evaluated. The developed method was applied for the determination of preservative M.P. and P.P. at concentration of 0.01 mg/mL and 0.1 mg/mL respectively. The method was successfully used for determining both compounds in sucralfate suspension.

VALIDATED RP-HPLC METHOD FOR DETERMINATION OF ENZALUTAMIDE IN BULK DRUG AND PHARMACEUTICAL DOSAGE FORM

INDIAN DRUGS ◽  
2016 ◽  
Vol 53 (11) ◽  
pp. 46-50
Author(s):  
Z. G Khan ◽  
◽  
S. S. Patil ◽  
P. K. Deshmukh ◽  
P. O. Patil
Keyword(s):  
Retention Time ◽  
Mobile Phase ◽  
High Performance ◽  
Reversed Phase ◽  
Hplc Method ◽  
Uv Detector ◽  
Chromatography Method ◽  
Pharmaceutical Dosage Form ◽  
Bulk Drug

Novel, isocratic reversed phase high performance liquid chromatography method was developed and validated for the determination of enzalutamide (EZA) in bulk drug and pharmaceutical formulation. Efficient separation was achieved on PrincetonSPHER C18 100A, 5μ (250×4.6 mm) under the isocratic mode of elution using acetonitrile: water (80:20) % V/V as a mobile phase pumped in to the column at flow rate 1.0 mL/min. The effluent was monitored at 237.0 nm using UV detector. EZA was eluted in the given mobile phase at retention time (tR) of 3.2 minutes. The standard calibration curve was linear over the concentration range 10 - 60 μg/mL with correlation coefficient 0.997. The method was validated for accuracy, precision, sensitivity, robustness, ruggedness and all the resulting data treated statistically. The system suitability parameters like retention time, theoretical plates, tailing factor, capacity factor were found within the limit.

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.

Ecofriendly chromatographic methods for determination of co-prescribed drugs, olanzapine and metformin, in rat plasma

Bioanalysis ◽  
2020 ◽  
Vol 12 (9) ◽  
pp. 597-613
Author(s):  
Aml A Emam ◽  
Neven M Habib ◽  
Hamada M Mahmoud ◽  
Nada S Abdelwhab ◽  
Maha M Abdelrahman
Keyword(s):  
Pharmaceutical Preparation ◽  
Rat Plasma ◽  
Reversed Phase ◽  
Hplc Method ◽  
Hypoglycemic Agent ◽  
Chromatographic Methods ◽  
Rp Hplc ◽  
Development And Validation ◽  
Developing System

Background: Olanzapine (OLZ) is one of most recommended drugs for the treatment of schizophrenia while metformin (MET) is the most commonly used hypoglycemic agent. Aim: Development and validation of two green, sensitive and accurate chromatographic methods for the simultaneous determination of OLZ along with the co-prescribed, MET. Materials & methods: TLC-densitometric method with a developing system consisting of methylene chloride:methanol:ethyl acetate:triethylamine (4:4:5:0.1, by volume) and a reversed-phase (RP)-HPLC method where the chromatographic separation was performed using ethanol:water mixture (50: 50, v/v) as a mobile phase. Results: TLC-densitometric method had linearity over concentration ranges of 160–4000 ng/band for OLZ and 150–4500 ng/band for MET, while RP-HPLC method was linear and validated over concentration range of 300–20000 ng/ml for OLZ and MET. Conclusion: Pharmacokinetic study was successfully performed and suggested the possibility of co-administration of MET with OLZ and their further formulation in one pharmaceutical preparation to enhance patient’s compliance.

scholarly journals Simultaneous Estimation of Glimepiride, Rosiglitazone and Pioglitazone Hydrochloride in the Pharmaceutical Dosage Form

2010 ◽  
Vol 7 (4) ◽  
pp. 1326-1333 ◽  
Author(s):  
Freddy H. Havaldar ◽  
Dharmendra L. Vairal
Keyword(s):  
Dosage Form ◽  
Pharmaceutical Preparation ◽  
Reversed Phase ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Pharmaceutical Dosage Form ◽  
Constant Flow Rate ◽  
Phase Liquid ◽  
Liquid Chromatographic

A simple, specific, accurate and economical gradient reversed phase liquid chromatographic (RP-HPLC) method was developed and subsequently validated for the determination of glimipiride, rosiglitazone and pioglitazone hydrochloride. Separation was achieved with a nucleodur C–18 column having 250×4.6 mm i.d. with 5 µm particle size and water HPLC grade adjusted to pH 3.0 using diluted orthophosphoric acid and acetonitrile (80:20 v∕v) with gradient program as eluent at a constant flow rate of 0.8 ml per min. UV detection was performed at 215 nm. The retention time of glimipiride, rosiglitazone and pioglitazone hydrochloride were about 17.9 min, 6.31 min and 8.24 min respectively. This method is simple, rapid and selective and can be used for routine analysis of antidiabetic drugs in pharmaceutical preparation. The proposed method was validated and successfully used for estimation of glimipiride, rosiglitazone and pioglitazone hydrochloride in the pharmaceutical dosage form.

Molecular and Quantum Mechanical Study for the Separation of Cefprozil in the Presence of Its Alkaline Degradation Product Using RP-HPLC with UV Detection

2017 ◽  
Vol 100 (2) ◽  
pp. 392-399 ◽  
Author(s):  
Khalid A M Attia ◽  
Mohammed W I Nassar ◽  
Mohamed B El-Zeiny ◽  
Ahmed Serag
Keyword(s):  
Degradation Product ◽  
Generation Cephalosporin ◽  
Reversed Phase ◽  
Hplc Method ◽  
Uv Detection ◽  
Quantum Mechanical ◽  
Rp Hplc ◽  
Quantum Mechanical Study ◽  
Alkaline Conditions

Abstract A reversed-phase HPLC method (RP-HPLC) with UV detection was developed and validated for the quantitative determination of cefprozil, a second-generation cephalosporin. Due to β-lactam ring instability under alkaline conditions, this RP-HPLC method was applied for the determination of cefprozil in the presence of its possible degradation product. The interactions that govern the separation process with stationary phase were investigated at both molecular and quantum mechanical levels. Moreover, electrostatic potential maps were generated to determine the sites of interaction with mobile phase. The suggested method was validated in compliance with International Conference on Harmonization guidelines and successfully applied for the determination of cefprozil in its commercial pharmaceutical formulation.

scholarly journals Chromatographic Methods for the Determination of Primula Acid 1 Content in Primulae extractum fluidum

2020 ◽  
Keyword(s):  
Calibration Curve ◽  
Mobile Phase ◽  
Active Component ◽  
Reversed Phase ◽  
Hplc Method ◽  
Reversed Phase Chromatography ◽  
Triterpenoid Saponins ◽  
Simple Preparation ◽  
Primula Veris

Primula veris L. (Primulaceae)is healing plant, whose root is officially used to treat cough associated with cold. Other reported indications are respiratory, thoracic and mediastinal disorders. These effects are result of high contents of triterpenoid saponins and phenolic glycosides. Primula acid 1 (PA 1, also primulasaponin 1) is main active component in Primula elatior L. This paper presents an optimized high pressure liquid chromatography (HPLC) method for the determination of primula acid 1 content in Primulae extractum fluidum. TLC was performed to check for the presence of the substance of interest. The determination was performed by reversed phase chromatography using C18 as a stationary phase. The mobile phase used for separation consisted of 0.2% H3PO4 and acetonitrile. This method was validated through different parameters. The detection limit for primula acid 1 was LD=10.41 µg/ml, and the quantification limitwas LQ=34.69 µg/ml. In order to determine the content of primula acid 1, a calibration curve was constructed, and the content of primula acid 1 was calculated by the equation of the calibration curve and was 0.2793 mg per gram of extract. The results and simple preparation of sample show that HPLC is the method of choice for this type of analysis.

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