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Validation of a simple and rapid UV spectrophotometric method for dexamethasone assay in tablets
Friedrich, Rossana Barcellos;Ravanello, Aline;Cichota, Luiz Carlos;Rolim, Clarice Madalena Bueno;Beck, Ruy Carlos Ruver;
Química Nova , 2009, DOI: 10.1590/S0100-40422009000400038
Abstract: this work reports the validation of an analytical uv spectrophotometric method to assay dexamethasone in tablets (assay and dissolution studies). the method was linear in the range between 1 and 30 μg ml-1 presenting a good correlation coefficient (r = 0.9998, n = 7). precision and accuracy analysis showed low relative standard deviation (< 2.00%) and good percentual recoveries (95-105%). the procedure was linear, accurate, precise, and robust. the method is simple, and it has low cost. it does not use polluting reagents and can be applied in dissolution studies, being an adequate alternative to assay dexamethasone in tablets.
DEVELOPMENT AND SIMULTANEOUS VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR THE ASSAY OF MONTELUKAST AND RUPATADINE IN SOLID DOSAGE FORM  [PDF]
Parimala R,Vasanth PM,Ramesh T,Ramesh Malothu
International Research Journal of Pharmacy , 2012,
Abstract: This paper emphasizes on a new simple, accurate, rapid and precise Isocratic Reverse Phase HPLC method for Simultaneous Estimation and Validation of Montelukast sodium and Rupatadine fumarate in Tablet formulation.The Method was performed on Shimadzu-10AT HPLC system using YMC Pack pro-C4 butyl column-3u particle size(150x4.6mm id) and flow rate of 1ml/min with a load of 10ul. The mobile phase consists of organic phase as Acetonitrile and aqueous phase i.e buffer as Ammonium acetate adjusted to pH-3+0.2 with Acetic acid in the ratio of 80:20. Tailing modifier 1-Octane sulphonic acid was used in the experiment. The detection was carried out at 252nm. Retention time for Montelukast and Rupatadine were 3.4min and 4.1min respectively. Linearity was calculated over the range of 1-100ug/ml for Montelukast and Rupatadine respectively. The % regression for both drugs found to be at 0.999. Validation parameters like accuracy, precision, linearity, robustness, ruggedness were done according to ICH guidelines.
Simultaneous Determination of Ciprofloxacin Hydrochloride and Dexamethasone Sodium Phosphate in Eye Drops by HPLC
Prakash Katakam,Karanam R. Sireesha
Journal of Chemistry , 2012, DOI: 10.1155/2012/187824
Abstract: A liquid chromatographic method was developed and validated for the simultaneous determination of ciprofloxacin hydrochloride and dexamethasone sodium phosphate in bulk and pharmaceutical formulations. Optimum separation was achieved in less than 5 min using a C18 column (250 mmx4.6 mm i.d, 5μ particle size) by isocratic elution. The mobile phase consisting of a mixture of mixed phosphate buffer (pH 4) and acetonitrile (65:35, v/v) was used. Column effluents were monitored at 254 nm at a flow rate of 1ml/min. Retention times of ciprofloxacin hydrochloride and dexamethasone sodium phosphate were 2.0 and 3.16 min respectively. The linearity of ciprofloxacin hydrochloride and dexamethasone sodium phosphate was in the range of 3-18 μg/ml and 1-6 μg/ml respectively. Developed method was economical in terms of the time taken and amount of solvent consumed for each analysis. The method was validated and successfully applied to the simultaneous determination of ciprofloxacin hydrochloride and dexamethasone sodium phosphate in bulk and pharmaceutical formulations.
Interfacial Properties of Ethyl Cellulose/Cellulose Acetate Blends by HPLC
GAO Su-lian,ZHOU Ning-guo,ZHANG Xiu-zhen,ZHANG Wei,
高素莲
,周宁国,张秀真,张玮

过程工程学报 , 2007,
Abstract: The high performance liquid chromatography method (HPLC) with ethyl cellulose/cellulose acetate (EC/CA)blends and EC as column packing material, and small molecular weight compound as probe molecules was employed to measure the retention volume (VR) and equilibrium distribution coefficient (K) of both inorganic and organic solutes. The interfacial separation properties of EC/CA blends were characterized by the HPLC data. The effects of the blends on the inteffacial adsorption properties, hydrophilicity, affinity, polar and non-polar parameters of EC membrane materials were studied subsequently. The research results indicate that the interfacial adsorption properties and hydrophilicity of EC have been improved by solution blending with CA. The alloys are superior to EC in the separation efficiency for non-dissociable polar organic solute. The EC/CA alloy (80:20, ω) is suitable for desalting and desaccharifying.
HPLC method modification and validation for quantification of Ibuprofen  [cached]
Ghassan Z. Abdullah,Muthanna F. Abdulkarim,Ibrahim M. Salman,Omar Z. Ameer
International Journal of Advances in Pharmaceutical Sciences , 2011, DOI: 10.5138/195
Abstract: Among the various NSAIDs used in the treatment of joint pain and osteoarthritis, ibuprofen, a propionic acid derivative, has been widely used for these purposes. In the present investigation, we modified and validated an HPLC method to obtain an accurate, sensitive and precise procedure to be exploited in the quantification of ibuprofen concentrations without interference from other ingredients present in the formulation. The HPLC method reported by Owen et al. (1987) was modified to fulfill our objectives, since the mobile phase used by the authors did not efficiently separate the drug peak from those of the formulation excipients. The modified mobile phase comprised 5 mM of disodium hydrogen phosphate adjusted to pH 3 with concentrated orthophosphoric acid, methanol and acetonitrile at ratios of 28:20:52, respectively. The method was found to be specific, precise, accurate and reproducible when carried out on intra-day and inter-day basis. The limit of detection and quantification were determined to be 0.03125 μg/mL and 0.0625 μg/mL, respectively. The data collectively showed that the current HPLC method is sufficiently sensitive to detect low concentration ranges of ibuprofen present in poor-transference topical delivery systems. Keywords: HPLC, Ibuprofen, Modification and Validation, NSAID.
Analytical method development and validation of different marketed Didanosine tablets by RP-HPLC
R. Sathiya sundar, I. Carolin nimila, J. Ashok kumar,,T.M. Vijaya kumar, G. Poovi,R. Sankar anand
International Journal of Research in Pharmaceutical Sciences , 2010,
Abstract: A Simple and suitable analytical method for validation of Didanosine (DDI) by reverse phase high performance liquid chromatographic (RP-HPLC) method. The method was performed on a RP-HPLC (Agilent 1120 LC Germany) model, C-18 Zorabax column, 4.6 mm X 250 mm, 5μm particle size. The mobile phase was mixture of methanol and 0.01M sodium acetate buffer adjusted to the pH 6.5 (75:25) at flow rate of 1.2 ml/min. UV detection was performed at 250 nm and the linearity was found to be 10 to 60 μg/ml with a correlation coefficient of 0.9998. The retention time for DDI was 5.17 min. The method showed good recovery and the relative standard deviation of intra and inter day assay results were 99.96% to 100.05 %. This method used for the analysis of different marketed DDI tablets.
In vivo biodistribution, anti-inflammatory, and hepatoprotective effects of liver targeting dexamethasone acetate loaded nanostructured lipid carrier system
Min-ting Wang, Yun Jin, Yun-xia Yang, et al
International Journal of Nanomedicine , 2010, DOI: http://dx.doi.org/10.2147/IJN.S10393
Abstract: vivo biodistribution, anti-inflammatory, and hepatoprotective effects of liver targeting dexamethasone acetate loaded nanostructured lipid carrier system Original Research (4601) Total Article Views Authors: Min-ting Wang, Yun Jin, Yun-xia Yang, et al Published Date July 2010 Volume 2010:5 Pages 487 - 497 DOI: http://dx.doi.org/10.2147/IJN.S10393 Min-ting Wang1, Yun Jin1, Yun-xia Yang2, Chun-yan Zhao1, Hong-Yun Yang1, Xue-fan Xu1, Xuan Qin1, Zhao-dan Wang2, Zhi-Rong Zhang1, Yan-lin Jian3, Yuan Huang1 1Key Laboratory of Drug Targeting and Drug Delivery System, Ministry of Education, West China School of Pharmacy, 2West China School of Preclinical and Forensic Medicine, Sichuan University, Chengdu, People’s Republic of China; 3Shenzhen Second People’s Hospital, Shenzhen, People’s Republic of China Abstract: We aimed to evaluate whether the enhancement of the liver accumulation and anti-inflammatory activity of dexamethasone acetate (DXMA) could be achieved by incorporating it into nanostructured lipid carrier (NLCs). DXMA-NLCs were prepared using a film dispersion-ultrasonication method and characterized in terms of particle size, PDI, zeta potential, differential scanning calorimetry, drug loading capacity, encapsulation efficiency, and in vitro release. The biodistribution and pharmacokinetics of DXMA-NLCs in mice were significantly different from those of the DXMA solution (DXMA-sol). The peak concentration of DXMA-NLCs was obtained half an hour after intravenous administration. More than 55.62% of the total administrated dose was present in the liver. An increase of 2.57 fold in the area under the curve was achieved when compared with that of DXMA-sol. DXMA-NLCs exhibited a significant anti-inflammatory and hepatoprotective effect on carrageenan-induced rats and carbon tetrachloride-induced mice compared with DXMA-sol. However, the effect was not in proportion to the dosage. The intermediate and low dosages presented better effects than DXMA-sol. All results indicate that NLCs, as a novel carrier for DXMA, has potential for the treatment of liver diseases, increasing the cure efficiency and decreasing the side effects on other tissues.
In vivo biodistribution, anti-inflammatory, and hepatoprotective effects of liver targeting dexamethasone acetate loaded nanostructured lipid carrier system  [cached]
Min-ting Wang,Yun Jin,Yun-xia Yang,et al
International Journal of Nanomedicine , 2010,
Abstract: Min-ting Wang1, Yun Jin1, Yun-xia Yang2, Chun-yan Zhao1, Hong-Yun Yang1, Xue-fan Xu1, Xuan Qin1, Zhao-dan Wang2, Zhi-Rong Zhang1, Yan-lin Jian3, Yuan Huang11Key Laboratory of Drug Targeting and Drug Delivery System, Ministry of Education, West China School of Pharmacy, 2West China School of Preclinical and Forensic Medicine, Sichuan University, Chengdu, People’s Republic of China; 3Shenzhen Second People’s Hospital, Shenzhen, People’s Republic of ChinaAbstract: We aimed to evaluate whether the enhancement of the liver accumulation and anti-inflammatory activity of dexamethasone acetate (DXMA) could be achieved by incorporating it into nanostructured lipid carrier (NLCs). DXMA-NLCs were prepared using a film dispersion-ultrasonication method and characterized in terms of particle size, PDI, zeta potential, differential scanning calorimetry, drug loading capacity, encapsulation efficiency, and in vitro release. The biodistribution and pharmacokinetics of DXMA-NLCs in mice were significantly different from those of the DXMA solution (DXMA-sol). The peak concentration of DXMA-NLCs was obtained half an hour after intravenous administration. More than 55.62% of the total administrated dose was present in the liver. An increase of 2.57 fold in the area under the curve was achieved when compared with that of DXMA-sol. DXMA-NLCs exhibited a significant anti-inflammatory and hepatoprotective effect on carrageenan-induced rats and carbon tetrachloride-induced mice compared with DXMA-sol. However, the effect was not in proportion to the dosage. The intermediate and low dosages presented better effects than DXMA-sol. All results indicate that NLCs, as a novel carrier for DXMA, has potential for the treatment of liver diseases, increasing the cure efficiency and decreasing the side effects on other tissues.Keywords: dexamethasone acetate, nanostructured lipid carrier, liver targeting
Development and validation of a RP-HPLC method for estimation of montelukast sodium in bulk and in tablet dosage form  [cached]
Singh R,Saini P,Mathur S,Singh G
Indian Journal of Pharmaceutical Sciences , 2010,
Abstract: The present work describes a simple, precise and accurate HPLC method for estimation of montelukast sodium in bulk and in tablet dosage form. The separation was achieved by using octadecylsilane column (C18) and acetonitrile:1 mM sodium acetate adjusted to pH 6.3 with acetic acid in proportion of 90:10 v/v as mobile phase, at a flow rate of 1.5 ml/min. Detection was carried out at 285 nm. The retention time of montelukast sodium was found to be 3.4 min. The limit of detection was found 1.31 μg/ml and limit of quantification 3.97 μg/ml. The accuracy and reliability of the proposed method was ascertained by evaluating various validation parameters like linearity (1-100 μg/ml), precision, accuracy and specificity according to ICH guidelines. The proposed method provides an accurate and precise quality control tool for routine analysis of montelukast sodium in bulk and in tablet dosage form.
Development and Validation of Acyclovir HPLC External Standard Method in Human Plasma: Application to Pharmacokinetic Studies  [PDF]
Selvadurai Muralidharan,Jayarajakumar Kalaimani,Subramani Parasuraman,Sokkalingam Arumugam Dhanaraj
Advances in Pharmaceutics , 2014, DOI: 10.1155/2014/284652
Abstract: A simple, rapid, and selective RP-HPLC method was developed for the estimation of acyclovir in human plasma. The method involves a simple protein precipitation technique. Chromatographic separation was carried out on a reverse phase C18 column using mixture of 5?mM ammonium acetate (pH 4.0) and acetonitrile (40?:?60, v/v) at a flow rate of 1.0?mL/min with UV detection at 290?nm. The retention time of acyclovir was 4.12 minutes. The method was validated and found to be linear in the range of 25.0–150.0?ng/mL. Validation studies were achieved by using the fundamental parameters, including accuracy, precision, selectivity, sensitivity, linearity and range, stability studies, limit of detection (LOD), and limit of quantitation (LOQ). It shows recovery at 91.0% which is more precise and accurate compared to the other method. These results indicated that the bioanalytical method was linear, precise, and accurate. The new bioanalytical method was successfully applied to a pharmacokinetic linearity study in human plasma. 1. Introduction Acyclovir, 9-[(2-hydroxyethoxy)-methyl]-guanosine, is an acyclic guanosine derivative which exhibits a selective inhibition of herpesviruses replication with potent clinical antiviral activity against the herpes simplex and varicella-zoster viruses [1, 2]. There are many works published for the determination of acyclovir in biological fluids of different species. For a laboratory, to develop a method is sometimes a compromise between cost, time consumption, and purpose of study. Some of the reported methods about acyclovir quantification in human plasma supposed to be expensive sample extraction method by using liquid-liquid extraction. Several HPLC methods have been reported for determination of acyclovir in human serum using UV [3–13] or fluorescence detection [14–18]. We present herein for the first time, a sensitive and selective HPLC method for the acyclovir assay in human plasma. This paper describes a new sensitive bioanalytical method for acyclovir using RP-HPLC method. By this method, chromatographic conditions have been optimized and validated in accordance with FDA guidelines. This results in a more sensitive, less time consuming, and easier method of quantification compared to the other existing methods and it gives better recovery from the human plasma, which is 91.0%. The present method was found reliable and applicable for the bioequivalence studies. 2. Reagent and Materials Gift sample of acyclovir was obtained from Ranbaxy Pharmaceuticals, Sungai Petani, Malaysia. Acetonitrile (HPLC grade) was obtained from
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