نتایج جستجو برای: international conference on harmonization

تعداد نتایج: 8548523  

2013
Krishna Chaitanya Prasad M. Krishna Chaitanya Prasad Vidhya Sagar

The article reports on a development of RP-HPLC method for the quantitative determination of Levetiracetam in tablet dosage forms. The chromatographic separations were performed using Phenomenex C18 (250 mm x 4.6 mm i.d, 5 μm particle size) column at 40 oC temperatures. The optimum mobile phase consisted of methanol, water and acetonitrile in the ratio of 30:10:60. Auto sampler 20 μl was used ...

2012
Rakshit Kanubhai Trivedi Dhairyshil S. Chendake Mukesh C. Patel

A stability-indicating reversed-phase high performance liquid chromatography (RP-HPLC) method was developed for the simultaneous determination of Formoterol fumarate (FOR), Tiotropium bromide (TRI), and Ciclesonide (CLS) in a pulmonary drug product. The desired chromatographic separation was achieved on the Zorbax SB C8, 5 μm (150 × 4.6 mm) column, using gradient elution at 230 nm detector wave...

2009
Farzana S Bandarkar Pradeep R Vavia

Purpose: The present study was undertaken to develop a validated, rapid, simple and economic stability indicating reverse phase HPLC method for estimating meloxicam (MLX) in bulk and commercial preparations. Method: Reversed phase chromatographic analysis was performed on a C18 Hi Q Sil column with acetonitrile-water-glacial acetic acid [55:40:5 (% v/v)] at a flow rate of 1ml/min and detection ...

2014
N. VENUGOPAL A. VIJAYA BHASKAR REDDY G. MADHAVI

The detection and quantification of potential genotoxic impurities (PGIs) play an important role in the pharmaceutical industry. The industry needs highly selective and sensitive analytical methods for trace level quantification of these PGIs in drug substances. A sensitive and stability indicating LC-MS/MS method was developed for the simultaneous detection and quantification of (S)-4-(4-amino...

2013
Mashhour M. Ghanem Saleh A. Abu-Lafi

A direct, precise, and stability-indicating HPLC method that is based on reversed-phase liquid chromatography (RP-HPLC) coupled with a photodiode array detector (PDA) was developed, optimized, and validated for the simultaneous determination of sulfadiazine sodium (SDZS) and Trimethoprim (TMP) in Bactizine® forte injectable solution. The separation was achieved using a C18 column (250 mm×4.6 mm...

2012
Ramesh Yanamandra Chandra Sekhar Vadla Umamaheshwar Puppala Balaram Patro Yellajyosula. L. N. Murthy Parimi Atchuta Ramaiah

A new rapid, simple, sensitive, selective and accurate reversed-phase stability-indicating Ultra Performance Liquid Chromatography (RP-UPLC) technique was developed for the assay of Tolterodine Tartrate in pharmaceutical dosage form, human plasma and urine samples. The developed UPLC method is superior in technology to conventional HPLC with respect to speed, solvent consumption, resolution and...

2013
Rakesh Kumar Tekade Antony D'Emanuele Abdelbary Elhissi Ashish Agrawal Anurekha Jain Basel Tawfiq Arafat Narendra Kumar Jain

A rapid, sensitive, selective and validated reverse phase high-performance liquid chromatography (RP-HPLC) method for the estimation of paclitaxel in micro-sample of rat plasma and in culture of cancer cells was performed in this study. The mobile phase consisted of an optimized mixture of methanol:water: trifluroacetic acid (80: 20: 0.1, v/v/v). Column elution at a flow rate of 1 mL/minute wit...

2011
Nitish Sharma Surendra Singh Rao Namala Durga Atchuta Kumar Pingili Sunil Reddy Annarapu Malleswara Reddy

A selective, specific and stability-indicating gradient reverse phase high-performance liquid chromatographic (HPLC) method was developed for the determination of Ranitidine in presence of its impurities, forced degradation products and placebo substances such as saccharide and parabens. Ultraviolet detection was performed at 230 nm. Separate portions of the drug product and ingredients were ex...

Journal: :Journal of pharmaceutical and biomedical analysis 2017
Osama Chahrour John Malone Mark Collins Vrushali Salmon Catherine Greenan Amy Bombardier Zhongze Ma Nick Dunwoody

The new guidelines of the United States pharmacopeia (USP), European pharmacopeia (EP) and international conference on harmonization (ICH) regulating elemental impurities limits in pharmaceuticals signify the end of unspecific analysis of metals as outlined in USP 〈231〉. The new guidelines specify both daily doses and concentration/limits of elemental impurities in pharmaceutical final products...

Journal: :Acta poloniae pharmaceutica 2011
Jayanti Mukherjee Ayan Das Uday Sankar Chakrabarty Bijay Kumar Sahoo Goutam Dey Hira Choudhury Tapan Kumar Pal

This study describes development and subsequent validation of a reversed phase high performance liquid chromatographic (RP-HPLC) method for the estimation of nandrolone phenylpropionate, an anabolic steroid, in bulk drug, in conventional parenteral dosage formulation and in prepared nanoparticle dosage form. The chromatographic system consisted of a Luna Phenomenex, CN (250 mm x 4.6 mm, 5 micro...

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