Study of forced decomposition behavior of lamivudine using LC, LC–MS/TOF and MSn

Bedse, Gaurav; Kumar, Vijay; Singh, Saranjit

doi:10.1016/j.jpba.2008.10.002

Cited by 42 publications

(21 citation statements)

References 17 publications

(17 reference statements)

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“…A number of studies from our laboratory highlight the successful use of the same [105,[117][118][119][120][121][122][123][124][125][126]. The steps involved are critically discussed below.…”

Section: Lc-ms and Variantsmentioning

confidence: 99%

“…An orderly data compilation offers comprehensive review and thus makes interpretation easy. Examples of systematic recording of MS n and HRMS data along with derived information for the drug and DPs can be found in several publications from our laboratory [105,117,120,[123][124][125]. (ii) Tentative structure proposal: Normally, the information on accurate mass, elemental composition, number of nitrogens, labile hydrogens, RDB values, etc.…”

Section: Gaining Additional Information From Acquired Datamentioning

confidence: 99%

See 1 more Smart Citation

A critical review on the use of modern sophisticated hyphenated tools in the characterization of impurities and degradation products

Singh

Handa

Narayanam

et al. 2012

Journal of Pharmaceutical and Biomedical Analysis

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184

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Section: Lc-ms and Variantsmentioning

confidence: 99%

Section: Gaining Additional Information From Acquired Datamentioning

confidence: 99%

A critical review on the use of modern sophisticated hyphenated tools in the characterization of impurities and degradation products

Singh

Handa

Narayanam

et al. 2012

Journal of Pharmaceutical and Biomedical Analysis

Self Cite

184

View full text Add to dashboard Cite

“…Key is the search for "optimal" orthogonal assay methods, for example, HPlC-uV-MS/MS; these are able to provide, on the basis of relative retention time, identification and quantitation of all the degradation products. In order to cover "all" degradation products, so-called forced degradation studies, under light, heat, and humidity stressed conditions, are performed according to ICH proposed guidance [128]. Hence, for completeness, assay methods on the basis of ion chromatography or capillary electrophoresis are frequently applied for biologicals or more complex pharmaceutical ingredients.…”

Section: Chemical and Photostability Testingmentioning

confidence: 99%

MS Applications in Support of Medicinal Chemistry Sciences

Honing¹,

Ingelse²,

Pramanik³

2013

Mass Spectrometry for Drug Discovery and Drug Development

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In the drug discovery process, medicinal chemistry plays a crucial role in the optimal design and synthesis (production) of new chemical entities (NCEs) or new biological entities (NBEs); this is true for a single entity as well as a complete compound library. A key requirement in this field of science is the optimization of both the chemical and the biological properties of these potential drug-like compounds. Important criteria are the design of efficient synthesis routes, the balancing of the physical chemical properties with optimal in vitro and in vivo drug metabolism and pharmacokinetic (DMPK) processes, and a profound understanding of the pharmacodynamics in the appropriate pharmacological models. In the lead optimization stage, an important step is scaling up the synthesis route as needed for the execution of toxicology studies and the screening of suitable drug formulations. In summary, medicinal chemistry support includes participating in a large variety of activities and decision making processes that play a key role in the search for either a "first in class" new drug or a "best in class" new drug [1].These "drug discovery" processes are continuously under pressure, as the research and development (R&D) costs continue to increase and more data are requested before new drug candidates are taken into (pre-)clinical development. Hence, the choice of "targeted" high-throughput screening (HTS) libraries, the process of hit appraisal, and the understanding of target-ligand interactions can be considered the starting points for a new drug discovery program [2]. Next, the main focus is on the discovery of a lead compound; typically, this is a compound showing promising data regarding target affinity, reasonable efficacy in cellular models, good physical chemical parameters (i.e., a "drug-like" compound), and acceptable oral bioavailability in Mass Spectrometry for Drug Discovery and Drug Development, First Edition. Edited by Walter A. Korfmacher.

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“…Literature survey reveals that LAM is estimated individually and in combination with other drugs by UV spectrophotometry 8,9,10,15,16 , RP-HPLC 11,12,13,14,15,16 , plasma RP-HPLC 17,18,19 . Forced decomposition behavior of LAM using LC-MS/TOF 20 27,28 and HPTLC 29 methods have been reported. From the above literature survey it is very clear that no method has been reported for simultaneous determination of LAM and TDF.…”

Section: Lamivudine (Lam); [4-amino-1-[(2r5s)-2-(hydroxymethyl)-13-mentioning

confidence: 99%

Application of High-Performance Thin-Layer Chromatographic Method for the Simultaneous Determination of Lamivudine and Tenofovir Disoproxil Fumarate in Pharmaceutical Dosage Form

Chandra

Rathore

Lohidasan

et al. 2011

J. Chil. Chem. Soc.

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A simple, precise and accurate high performance thin layer chromatographic method has been developed for the simultaneous determination of lamivudine (LAM) and tenofovir disoproxil fumarate (TDF) in pharmaceutical dosage form. The separation was carried out on Merck HPTLC aluminum plates of silica gel 60 F 254 , (20 × 10 cm) with 250 µm thickness using chloroform: methanol: toluene (8: 2: 2, v/v/v) as mobile phase. HPTLC separation of the two drugs followed by densitometric measurement was carried out in the absorbance mode at 265 nm. The drugs were satisfactorily resolved with R f values of 0.27 ± 0.01 and 0.51 ± 0.01 for LAM and TDF, respectively. The linear regression analysis data for the calibration plots showed good linear relationship with r 2 =0.9999 and 0.9996 for LAM and TDF, respectively in the concentration range of 60-210 ng spot -1 for each drug. The method was validated for precision, robustness, specificity and accuracy. The limit of detection and quantitation were 20 and 40 ng spot , respectively for TDF. The proposed developed HPTLC method can be applied for identification and quantitative determination of LAM and TDF in bulk drug and pharmaceutical dosage form.

show abstract

Study of forced decomposition behavior of lamivudine using LC, LC–MS/TOF and MSn

Cited by 42 publications

References 17 publications

A critical review on the use of modern sophisticated hyphenated tools in the characterization of impurities and degradation products

A critical review on the use of modern sophisticated hyphenated tools in the characterization of impurities and degradation products

MS Applications in Support of Medicinal Chemistry Sciences

Application of High-Performance Thin-Layer Chromatographic Method for the Simultaneous Determination of Lamivudine and Tenofovir Disoproxil Fumarate in Pharmaceutical Dosage Form

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