HPTLC METHOD FOR SIMULTANEOUS DETERMINATION OF ROSUVASTATIN AND FENOFIBRTAE IN BULK AND PHARMACEUTICAL FORMULATION

Objective: Simultaneous quantification of Rosuvastatin and Fenofibrate tablets by HPTLC method was developed and validated as per International Conference on Harmonization [(ICH) Q2 (R1)] guideline. Methods: The chromatograms were developed using a mobile phase of ethyl acetate: acetic acid (20: 0.2, v/v) on aluminium pre-coated plates of silica gel G F254 of TLC plates and quantified by densitometric absorbance mode at 246 nm. Results: The Rf values were 0.31 ± 0.01 and 0.76 ± 0.01 for Rosuvastatin and Fenofibrate, respectively. The linearity of the method was found to be in the concentration range of 50-800 ng/band for both drugs. The limits of detection and quantification were 11.07 and 33.56 ng/band for Rosuvastatin and 12.76 and 38.68 ng/band for Fenofibrate. Conclusion: Developed densitometric method was found to be robust, precise, accurate, rapid and can be used to analyse fixed-dose tablet samples of Rosuvastatin and Fenofibrate

NOVEL HIGH-PERFORMANCE THIN-LAYER CHROMATOGRAPHIC METHOD FOR SIMPLE, ECONOMICAL, AND RAPID DETERMINATION OF FENOFIBRATE IN BULK AND PHARMACEUTICAL DOSAGE FORM

 Objective: A simple, novel, sensitive, and rapid high-performance thin-layer chromatographic (HPTLC) method has been developed and validated for quantitative determination of fenofibrate in bulk and formulations.Methods: The chromatographic development was carried out on HPTLC plates precoated with silica gel 60 F254 using a single solvent dichloromethane as a simple mobile phase. Densitometric detection was carried out at 292 nm.Results: Rf value of drug was found to be 0.33±0.02. The method was validated as per International Conference on Harmonization Guideline with respect to linearity, accuracy, precision, and robustness. The calibration curve was found to be linear over a range of 20–400° ng band−1° with a regression coefficient of 0.999. The method has proved high sensitivity and specificity.Conclusion: Proposed densitometric method was found to be new, simple, and economic for routine quantification of fenofibrate in bulk and pharmaceutical formulation

LIQUID CHROMATOGRAPHY TANDEM-MASS SPECTROMETRY METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ANALYSIS OF PARACETAMOL, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, CHLORPHENIRAMINE MALEATE, AND AMBROXOL HYDROCHLORIDE IN BULK AND IN TABLET DOSAGE FORM

Objective: The objective is to study liquid chromatography tandem-mass spectrometry (LC/MS/MS) method for simultaneous quantification of paracetamol (PCM), guaifenesin (GUA), phenylephrine hydrochloride (PE), chlorpheniramine maleate (CPM), and ambroxol hydrochloride (AMB) in tablet dosage form developed and validated as per the International Conference on Harmonization Q2 (R1) guideline. Methods: The chromatograms were developed using a gradient mobile phase of WATER:methanol. Flow rate used was to 0.3 ml/min. Quantitation was performed using multiple reaction monitoring (MRM) mode to study parent to product ion transition, for paracetamol. (m/z 152.0 ≥ 110.0), guaifenesin (m/z 199.0 ≥163.0), phenylephrine hydrochloride (m/z 168.0≥ 150.0), chlorpheniramine maleate (m/z 275.0 ≥ 230.0) and ambroxol hydrochloride (m/z 379.0 ≥ 263.8). Results: The retention times were found to be 1.76, 1.81, 1.90, 2.10, and 2.33 min for PCM, GUA, PE, CPM, and AMB, respectively. The linearity of the method was found to be in the concentration range of 10–200 ng/ml for PCM, GUA, PE, CPM, and AMB. Percentage relative standard deviation values for repeatability and intermediate precision studies were below 2%. Conclusion: Developed method was found to be robust, precise, accurate, rapid and can be used to analyze fixed-dose tablet formulation used in the study.Â

Dysphania ambrosioides (L.) Mosyakin & Clemants

Dysphania ambrosioides (L.) Mosyakin & Clemants (= Chenopodium ambrosioides L.) is an American aromatic species used as medicinal and culinary purposes since pre-Columbian times by Aztecs and Mayans in Mesoamerica (where is called epazote) and Andean communities and many others in South America (where is better known as paico). Currently, it is globally known by a wide diversity of cultures around the world, due to its cultivation and naturalization. Its uses are currently widespread in pluricultural contexts, by means the commercial circuits and mass media, especially the Internet. The main active constituents are essential oils, to which owes its aroma and flavor. It is toxic in high doses, but safe if is consumed in appropriated concentrations. The most widespread folk therapeutic use is as antiparasitic (anthelmintic, antimicrobial), and it is also employed against gastrointestinal disorders, as hypotensive, antipyretic, vulnerary, analgesic, anti-inflammatory, antitumor, sedative and anxiolytic, among others, many of which have been evaluated scientifically. The researches on its anticancer activity are very promising.Fil: Hurrell, Julio Alberto. Universidad Nacional de La Plata. Facultad de Ciencias Naturales y Museo. Laboratorio de Etnobotánica y Botánica Aplicada; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - La Plata; Argentin