scholarly journals Development and Validation of a Stability-Indicating High Performance Liquid Chromatographic (HPLC) Method for the Determination of Related Substances of Micafungin Sodium in Drug Substances

2013 ◽  
Vol 14 (11) ◽  
pp. 21202-21214 ◽  
Author(s):  
Shengsheng Zhu ◽  
Xiang Meng ◽  
Xin Su ◽  
Yongwei Luo ◽  
Zuyue Sun
Keyword(s):  
High Performance ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Stability Indicating ◽  
Related Substances ◽  
Drug Substances ◽  
Development And Validation ◽  
Liquid Chromatographic

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 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. 

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.

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.

Stereospecific Determination of Sertraline and its Impurities in Bulk Drug Using Cyclodextrins as a Chiral Selector

2020 ◽  
Vol 16 (7) ◽  
pp. 823-830 ◽  
Author(s):  
Navjot Kaur Sandhu ◽  
Durga Das Angehore ◽  
Neeraj Upmanyu ◽  
Pawan K. Porwal
Keyword(s):  
Mobile Phase ◽  
High Performance ◽  
Method Development ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Related Substances ◽  
System Suitability ◽  
Bulk Drug ◽  
Liquid Chromatographic

Background: Sertraline Hydrochloride, an oral anti-depressant, has two chiral centers and its cis enantiomers and trans diasteromers are defined as related substances by United State Pharmacopoeia and British Pharmacopoeia. Introduction: A selective, stereospecific and economical high performance liquid chromatographic (HPLC) method was developed for the determination of sertraline enantiomeric forms. The HPLC-UV method was developed and optimized in the terms of system suitability parameters. Methods: The elution was made using a mixture of -cyclodextrin (-CD) and hydroxypropyl - cyclodextrin (HP -CD). Analysis was performed on a Zorbax SB C-18 column (250 x 4.6mm), 5μ with the mobile phase consisting of 170mM KH2PO4 containing -CD and HP -CD (pH: 3.0 with dil. H3PO4) and acetonitrile (75:25, v/v). Flow rate was kept at 1.0mL/min and the detection was carried out by UV at 220nm. Enantio-separation for sertraline was carried out using two different CDs (β-CD and HP β- CD) at different concentrations in the mobile phase. Results: Complete resolution of all the four isomers was achieved using 9mM β-CD and 15mM HP β- CD in the mobile phase. The development was optimized using central composite quadric model, where concentration of -CD and HP -CD were varied and resolution between trans diastereomeric impurities was calculated as a response. Conclusion: Resolution between any pair of isomers was found to be more than 2. Method development and optimization leading to the best resolution between the isomers of sertraline is described in detail.

scholarly journals Development and validation of RP-HPLC method for determination of Duloxetine hydrochloride in bulk and dosage form

2012 ◽  
Vol 1 (5) ◽  
pp. 98-102 ◽  
Author(s):  
Chusena Narasimharaju Bhimanadhuni ◽  
Devala Rao Garikapati ◽  
Chintha Srinivas
Keyword(s):  
High Performance ◽  
Dosage Form ◽  
Pharmaceutical Journal ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Duloxetine Hydrochloride ◽  
Ich Guidelines ◽  
Development And Validation ◽  
Liquid Chromatographic

A reverse phase high performance liquid chromatographic method was developed for the determination of duloxetine hydrochloride in bulk and dosage form. The separation was effected on a kromasil ODS C18 column (250mmX4.6mm, 5?) using a mobile phase mixture of buffer and methanol in a ratio of 85:15 v/v at a flow rate of 1.0ml/min. The detection was made at 230nm. The retention time of duloxetine hydrochloride was found to be 3.443±0.06 min. Calibration curve was linear over the concentration range of 20-120?g/ml of duloxetine hydrochloride. The propose method was validated as per the ICH guidelines. The method was accurate, precise, specific and rapid found to be suitable for the quantitative analysis of the drug and dosage form.DOI: http://dx.doi.org/10.3329/icpj.v1i5.10281International Current Pharmaceutical Journal 2012, 1(5): 98-102

scholarly journals Stability Indicating Analytical Method Development and Validation of Efavirenz Quantification by High Performance Liquid Chromatographic Technique

2011 ◽  
Vol 8 (4) ◽  
pp. 1498-1503 ◽  
Author(s):  
R. Kumar ◽  
M. Sharma ◽  
G. R. Verma
Keyword(s):  
High Performance ◽  
Method Development ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Dihydrogen Phosphate ◽  
Chromatographic Technique ◽  
Stability Indicating ◽  
Stainless Steel Column ◽  
Development And Validation ◽  
Liquid Chromatographic

A stability-indicating high performance liquid chromatography (HPLC) method is developed for the quantification of efavirenz drug substance. Selected mobile phase is a combination of 50 volume of acetonitrile and 50 volume of 0.86% w/v solution of ammonium dihydrogen phosphate, pH adjusted to 3.0 with orthophosphoric acid. Optimized column is a stainless steel column packed with base deactivated octa decylsilyl silica gel and at 252 nm wavelength. Linearity of the method is found 40 μg/mL to 160 μg/mL with regression coefficient of 0.9995. The method is validated according to ICH guidelines.

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