Development and Validation of a High Performance Liquid Chromatographic Method for Simultaneous Determination of Vitamins A and D3 in Fluid Milk Products

2015 ◽  
Vol 98 (2) ◽  
pp. 390-396 ◽  
Author(s):  
Yang Chen ◽  
Ravinder M Reddy ◽  
Wenjing Li ◽  
Ramesh R Yettlla ◽  
Salvador Lopez ◽  
...  
Keyword(s):  
Simultaneous Determination ◽  
High Performance ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Array Detector ◽  
Technology Standard ◽  
Development And Validation ◽  
Liquid Chromatographic ◽  
Fluid Milk

Abstract An HPLC method for simultaneous determination of vitamins A and D3 in fluid milk was developed and validated. Saponification and extraction conditions were studied for optimum recovery and simplicity. An RP HPLC system equipped with a C18 column and diode array detector was used for quantitation. The method was subjected to a single-laboratory validation using skim, 2% fat, and whole milksamples at concentrations of 50, 100, and 200% of the recommended fortification levels for vitamins A and D3 for Grade “A” fluid milk. The method quantitation limits for vitamins A and D3 were 0.0072 and 0.0026 μg/mL,respectively. Average recoveries between 94 and 110%and SD values ranging from 2.7 to 6.9% were obtainedfor both vitamins A and D3. The accuracy of the method was evaluated using a National Institute of Standards and Technology standard reference material (1849a) and proficiency test samples.

DEVELOPMENT AND VALIDATION OF A NEW RP HPLC METHOD FOR ROUTINE DETERMINATION OF TEA TREE OIL IN BULK AND COSMECEUTICAL FORMULATIONS

INDIAN DRUGS ◽  
2019 ◽  
Vol 56 (07) ◽  
pp. 43-49
Author(s):  
B.P. Manjula ◽  
V. G Joshi ◽  
Siddamsetty Ramachandra Setty ◽  
M Geetha ◽  
Keyword(s):  
High Performance ◽  
High Performance Liquid Chromatographic ◽  
Reversed Phase ◽  
Hplc Method ◽  
Tea Tree Oil ◽  
Tea Tree ◽  
Liquid Chromatographic Method ◽  
Development And Validation ◽  
Liquid Chromatographic

Tea tree oil, an active ingredient of skin, hair and nail care cosmeceuticals, has claims for topical antimicrobial, analgesic and anti-inflammatory activity. Its complex composition is governed by ISO 4730:2017. Terpinene-4-ol is the principal constituent of the oil (35% - 48%) followed by γ-terpinene (14% -28%), α-terpinene (6%-12%) and 1,8-cineole (≤15%). A reversed-phase, isocratic high performance liquid chromatographic method has been developed and validated for routine determination of tea tree oil based on1,8-cineole content in bulk and commercially available cosmeceuticals using C18 column, methanol-water (70:30 v/v) as mobile phase and flow rate of 1mL/min. UV detection was done at 200 nm. Linearity of the method was established for 20-100μL/mL (R2 = 0.9992) with LOD, LOQ values of 0.5594 μL/mL and 5.5941μL/mL respectively. The % RSD values for robustness and precision were <1% and recovery ranged between 99.09-102.96%. The method was successfully applied for determination of 1,8-cineole content in cosmeceuticals.

scholarly journals Development and validation of an RP-HPLC method for the simultaneous determination of Escitalopram Oxalate and Clonazepam in bulk and its pharmaceutical formulations

2012 ◽  
Vol 1 (8) ◽  
pp. 193-198 ◽  
Author(s):  
Chusena Narasimharaju Bhimanadhuni ◽  
Devala Rao Garikapati ◽  
Pasupuleti Usha
Keyword(s):  
Simultaneous Determination ◽  
High Performance ◽  
Pharmaceutical Formulations ◽  
Pharmaceutical Journal ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Validation Parameters ◽  
Tablet Dosage ◽  
Liquid Chromatographic

A Simple, efficient and reproducible reverse phase high performance liquid chromatographic method was developed and validated for the Simultaneous determination of Escitalopram oxalate and Clonazepam in combined dosage form. The separation was effected on a Hypersil ODS C18 column (250mm X 4.6mm; 5µ) using a mobile phase mixture of buffer and acetonitrile in a ratio of 50:50 v/v at a flow rate of 1.0ml/min. The detection was made at 240nm. The retention time of Escitalopram oxalate and Clonazepam was found to be 2.840± 0.007min and 4.007±0.006 min. Calibration curve was linear over the concentration range of 20-120µg/ml and 1-6µg/ml for Escitalopram oxalate and Clonazepam. All the analytical validation parameters were determined and found in the limit as per ICH guidelines, which indicates the validity of the method. The developed method is also found to be precise, accurate, specific, robust and rapid for the simultaneous determination of Escitalopram oxalate and Clonazepam in tablet dosage forms.DOI: http://dx.doi.org/10.3329/icpj.v1i8.11249 International Current Pharmaceutical Journal 2012, 1(8): 193-198 

scholarly journals Development and validation for determination of lisinopril dihydrate in bulk drug and formulation using RP-HPLC method

2018 ◽  
Vol 3 (2) ◽  
pp. 14-18
Author(s):  
Zahid Zaheer ◽  
Sarfaraz Khan ◽  
Mohammad Sadeque ◽  
Hundekari G. I. ◽  
Rana Zainuddin
Keyword(s):  
High Performance ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Rp Hplc ◽  
Liquid Chromatographic Method ◽  
Bulk Drug ◽  
Development And Validation ◽  
Liquid Chromatographic ◽  
Isocratic Mode

A simple, reproducible and efficient reverse phase high performance liquid chromatographic method was developed for Lisinopril in bulk drug and formulation. A column having 150 × 4.6 mm in isocratic mode with mobile phase containing acetonitrile: phosphate buffer (70:30; adjusted to pH 3.0) was used. The flow rate was 0.8 ml/min and effluent was monitored at 216 nm. The retention time (min) and linearity range (μg/ml) for Lisinopril was (1.510) and (10-35). The developed method was found to be accurate, precise and selective for determination of Lisinopril in bulk and formulation.

scholarly journals DEVELOPMENT AND VALIDATION OF A HIGH PERFORMANCE LIQUID CHROMATOGRAPHIC METHOD DETERMINATION OF ZIDOVUDINE ENCAPSULATED IN PCL NANOPARTICLES

2017 ◽  
Vol 1 (2) ◽  
pp. 1-8
Author(s):  
Milena Cristina Ribeiro Souza Magalhães ◽  
Alisson Samuel Portes Caldeira ◽  
Hanna De Sousa Rocha Almeida ◽  
Sílvia Ligório Fialho ◽  
Armando Da Silva Cunha Junior
Keyword(s):  
Mobile Phase ◽  
High Performance ◽  
High Performance Liquid Chromatographic ◽  
Reversed Phase ◽  
Hplc Method ◽  
Liquid Chromatographic Method ◽  
Development And Validation ◽  
Liquid Chromatographic ◽  
Isocratic Mode

A reversed-phase high-performance liquid chromatographic (HPLC) method was developed and validated for the determination of encapsulation efficiency of zidovudine in nanoparticules. The method was carried out in isocratic mode using 0.040M sodium acetate: methanol: acetonitrile: glacial acetic acid (880:100:20:2) as mobile phase, a C8 column at 25ºC and UV detection at 240 nm. The method was linear (r2 ˃ 0.99) over the range of 25.0-150.0 μg/mL, precise (RSD ˂ 5%), accurate (recovery = 100.5%), robust and selective. The validated HPLC-UV method can be successfully applied to determine the rate of zidovudine in nanoparticules.

Development and Validation of Midostaurin Assay by RP-HPLC Method

2018 ◽  
Vol 11 (6) ◽  
pp. 4318-4322
Author(s):  
Abrar Ahmed ◽  
Tayyaba Mahtab ◽  
Sumaiyya Saleem
Keyword(s):  
Myeloid Leukemia ◽  
High Performance ◽  
Kinase Inhibitor ◽  
Pharmaceutical Formulations ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Liquid Chromatographic Method ◽  
Development And Validation ◽  
Liquid Chromatographic

Midostaurin is a multi-targeted protein kinase inhibitor that has been used for the treatment of acute myeloid leukemia.  Here, a rapid and precise reverse phase high-performance liquid chromatographic method has been developed for the validation of midostaurin, in its API form as well as in capsule dosage form. Chromatography was carried out on a X-Bridge C18 (4.6 x 250 mm, 5 µm) column using a mixture of methanol: water (75:25% v/v) as the mobile phase at a flow rate of 1.0 mL/min, the detection was carried out at 243nm and the retention time of the midostaurin was found to be 3.155. The method produce linear responses in the concentration range of 10-50 µg/mL of midostaurin. The method precision for the determination of assay was below 2.0 % RSD. The LOD and LOQ values obtained were 1.2 µg/mL and 3.8 µg/mL respectively. There were no significant changes observed upon changing chromatographic conditions indicating the method to be robust. Therefore this validated method can be useful in the quality control of bulk and pharmaceutical formulations of midostaurin. 

scholarly journals Simultaneous determination of ethinyl estradiol and drospirenone in oral contraceptive by high performance liquid chromatography

2013 ◽  
Vol 49 (3) ◽  
pp. 521-528 ◽  
Author(s):  
Viviane Benevenuti Silva ◽  
Angel Arturo Gaona Galdos ◽  
Cintia Maria Alves Mothe ◽  
Michele Bacchi Pallastrelli ◽  
Maria Segunda Aurora Prado ◽  
...  
Keyword(s):  
Simultaneous Determination ◽  
Mobile Phase ◽  
High Performance ◽  
Ethinyl Estradiol ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Elution Time ◽  
Liquid Chromatographic Method ◽  
Liquid Chromatographic

A simple, rapid, economical and reliable high performance liquid chromatographic method has been developed and successfully applied in simultaneous determination of ethinyl estradiol and drospirenone in coated tablets. The HPLC method was performed on a LiChroCART® 100RP column (125x4 mm i.d., 5 µm) with acetonitrile:water 50:50 (v/v) as mobile phase, pumped at a flow rate of 1.0 mL.min-1. The fluorescence detection for ethinyl estradiol was made at λex= 280 nm and λem= 310 nm and a UV detection for drospirenone was made at 200 nm. The elution time for ethinyl estradiol and drospirenone were 4.0 and 5.7 min, respectively. The method was validated in accordance to USP 34 guidelines. The proposed HPLC method presented advantages over reported methods and is suitable for quality control assays of ethinyl estradiol and drospirenone in coated tablets.

scholarly journals RP-HPLC METHOD FOR SIMULTANEOUS DETERMINATION OF METRONIDAZOLE AND OFLOXACIN IN SYNTHETIC MIXTURE

2016 ◽  
Vol 4 ◽  
pp. 900-905
Author(s):  
Vania Maslarska ◽  
Boyka Tsvetkova ◽  
Lily Peikova ◽  
Stanislav Bozhanov
Keyword(s):  
High Performance ◽  
Analytical Procedure ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Phosphoric Acid Solution ◽  
Synthetic Mixture ◽  
Development And Validation ◽  
Liquid Chromatographic ◽  
Isocratic Mode

Development and validation of a high-performance liquid chromatographic analytical procedure for simultaneously determining metronidazole and ofloxacin in a synthetic mixture is described in this paper. The separation was made with a LiChrosorb® RP-18 (250 × 4.6 mm) column, at 30 °C temperature, with isocratic mode and mobile phase, containing triethylamine, acetonitrile, and 0.3% o-phosphoric acid solution (0.02:20:80 v/v/v). Eluent was monitored at 290 nm and the flow rate was 1.0 ml/min. Metronidazole and ofloxacin were effectively separated with retention time (tr) of 3.42 min and 6.15 min, respectively, within the selected chromatographic conditions. The method was validated for analytical parameters: specificity, linearity, precision, accuracy, and limits of detection and quantitation. The calibration curves were linear in the concentration range of 12.5 to 100.0 µg/ml for metronidazole and ofloxacin, and the regression coefficients were more than 0.999. For metronidazole and ofloxacin the recovery was 100.01% and 100.04%, respectively. This analytical procedure is applicable for the quality control of drug formulations.

A Novel HPLC Method for Simultaneous Determination of Methyl, Ethyl, n-propyl, Isopropyl, n-butyl, Isobutyl and Benzyl Paraben in Pharmaceuticals and Cosmetics

2020 ◽  
Vol 23 ◽  
Author(s):  
Saniye Özcan ◽  
Serkan Levent ◽  
Nafiz Öncü Can
Keyword(s):  
High Performance ◽  
Gradient Elution ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Array Detector ◽  
Methyl Ethyl ◽  
Photodiode Array Detector ◽  
Photodiode Array ◽  
Liquid Chromatographic

: The alkyl esters of p-hydroxybenzoic acid at the C-4 position, “the parabens,” including methyl, ethyl, propyl, and butyl, are widely used as antimicrobial preservatives in foods, cosmetics, and pharmaceuticals. Official regulations on the use of these compounds make their analysis essential for the estimation of their exposure. On this basis, the presented study was realized to develop a simple, selective and cheap high-performance liquid chromatographic method for the quantitative determination of methyl paraben (MP), ethyl paraben (EP), n-propyl paraben (NPP), isopropyl paraben (IPP), n-butyl paraben (NBP), isobutyl paraben (IBP) and benzyl paraben (BP) in pharmaceuticals and cosmetic products. The chromatographic separation of the analytes was achieved under flow rate gradient elution conditions using a C18-bonded core-shell silica particle column (2.6 μm particle size, 150 × 3.0 mm from Phenomenex Co.). The samples were injected into the system as aliquots of 1.0 μL, and the compounds were detected by using a photodiode array detector set at 254 nm wavelength. With this technique, seven paraben derivatives can be determined in the concentration range of 250-2000 ng/mL. The recovery of the method is in the range of 99.95-13.84%, and the RSD is at a maximum value of 3.95%. The proposed method was fully validated and successfully applied to different pharmaceutical and cosmetic samples (n=16), including syrups, suspensions, oral sprays, gels, etc. At least one paraben derivative was detected in six of the samples, and was determined quantitatively. The maximum amount of a paraben derivative found in the analyzed samples is 321.7 ng/mL, which was MP. To the best of our knowledge, this is the first LC method, which is applicable both on pharmaceutical and cosmetic samples.

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