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Journal of Pharmaceutical Analysis 2012年第4期2卷 306-309页

作者： Prajesh Prajapati Vipul Vaghela Deepak Rawtani Harshad Patel Jasmin Kubavat Dharmendra Baraiya Department of Pharmaceutical Analysis Institute of Research and DevelopmentGujarat Forensic Sciences UniversitySector-18ANr.Police bhavan A.R.College of Pharmacy and G.H.Patel Institute of Pharmacy

A novel,safe,economic and sensitive method of spectrophotometric estimation has been developed using Azeoptropic mixture (water∶methanol:60∶40,v/v) for the quantitative determination of Lornoxicam,a practically water-insoluble drug.Hence,Lornoxicam stock solution was prepared in Azeoptropic mixture.Lornoxicam showed maximum absorbance at 383 nm.Beer's law was obeyed in the concentration range 4-24 μg/mL with regression coefficient of 0.999.The method was validated in terms of linearity (R2=0.999),precision (CV for intra-day and inter-day was 0.28 0.68 and 0.12-0.92,respectively),accuracy (98.03-100.59％ w/w) and specificity.This method is simple,precise,accurate,sensitive and reproducible and can be used for the routine quality control testing of the marketed formulations.

关键词： Analgesic Chlortenoxicam Lornoxicam Oxicam Spectrophotometric Azeotropic mixture

Liquid chromatography electrospray ionization tandem mass spectrometry(LC/ESI-MS/MS) method for quantitative estimation of moxifloxacin in human plasma

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Journal of Chinese Pharmaceutical Sciences 2014年第3期23卷 159-164页

作者： Vipul.M.Vaghela Prajesh Prajapati Hetal K.Patel A.R.College of Pharmacy and G.H.Patel Institute of Pharmacy Institute of Research and Development Gujarat Forensic Sciences University Shree Swaminarayan Sanskar Pharmacy College

A rapid and sensitive liquid chromatography tandem mass spectrometry(LC-MS/MS) method has been developed and validated for the determination of moxifloxacin(MOXI) in human plasma. After a simple protein precipitation using acetonitrile, the post treatment samples were analysed on a C18 column interfaced with a Triple Quadropole Tandem Mass Spectrometer. Positive electrospray ionization was employed as the ionization source. The mobile phase consisted of 0.1% formic acid–acetonitrile(60:40, v/v). Ciprofloxacin(CIPRO) was used as an internal standard. The analyte and internal standard(CIPRO) were monitored in the multiple reaction monitoring mode(MRM). The mass transition ion-pair has been followed as m/z 402→358.2 for MOXI and 332→288.1 for CIPRO. The method was linear in the concentration range of 25–5000 ng/mL. The lower limit of quantification was 25 ng/mL. The intra- and inter-day precision(relative standard deviation) and accuracy(relative error) values were within 12.4%. Each plasma sample was analyzed within 3 min.

关键词： Moxifloxacin Ciprofloxacin Human plasma Liquid chromatography tandem mass spectrometry Electrospray ionization

Sensitive method for rapid estimation of Lornoxicam in bulk and its dosage form by RP-HPLC

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Journal of Chinese Pharmaceutical Sciences 2013年第1期22卷 110-113页

作者： prajapati prajesh Vaghela Vipul Baraiya Dharmendra Institute of Research and Development Gujarat Forensic Sciences University A.R. College of Pharmacy and G.H.Patel Institute of Pharmacy

Lornoxicam (6-chloro-4-hydroxy-2-methyl-N-2-pyridyl-2H-thieno-[2,3-e]-1,2-thiazine-3-carboxamide-1,1-dioxide) is persist as a non-steroidal anti-inflammatory drug of the oxicam class with analgesic, anti-inflammatory and antipyretic properties. A fast, accurate and sensitive chromatographic method for estimation of Lornoxicam was developed as no official method available for detection. The chromatographic separation employs isocratic elution by utilizing an inertsil ODS-C 18 , 250 mm×4.6 mm, 5 μm columns. Mobile phase consisting of solvent (40 mL acetonitrile and 60 mL 0.1 M phosphate buffer (pH 6.8 was adjusted with triethylamine)) endowed at a flow rate of 1.0 mL/min. The analyte was detected and quantified at 290 nm using UV detector. The method was validated according to ICH guidelines, illustrating to be accurate (recovery 99.08%-101.13%) and precise (intraday (0.27-1.32) and interday (0.59-1.59))within the corresponding linear range (10-60 μg/mL) with r 2 0.9992.

关键词：药物药物化学药物物理学 RP-HPLC

Development of forced degradation and stability indicating studies of drugs——A review

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Journal of Pharmaceutical Analysis 2014年第3期4卷 159-165页

作者： Blessy M Ruchi D.Patel prajesh N.prajapati Y.K.Agrawal Department of Pharmaceutical Analysis Institute of Research and DevelopmentGujarat Forensic Sciences University Sector-18ANr.Police BhavanGandhinagar 382007GujaratIndia

Forced degradation is a degradation of new drug substance and drug product at conditions more severe than accelerated conditions. It is required to demonstrate specificity of stability indicating methods and also provides an insight into degradation pathways and degradation products of the drug substance and helps in elucidation of the structure of the degradation products. Forced degradation studies show the chemical behavior of the molecule which in turn helps in the development of formulation and package. In addition, the regulatory guidance is very general and does not explain about the performance of forced degradation studies. Thus, this review discusses the current trends in performance of forced degradation studies by providing a strategy for conducting studies on degradation mechanisms and also describes the analytical methods helpful for development of stability indicating method.

关键词： Degradation conditionsDegradation product Forced degradation Stability indicatingmethod Stress testing