Novel simultaneous HPLC Method for Cleaning Validation of Four API Drugs
Journal Title: Scholars Academic Journal of Pharmacy - Year 2017, Vol 6, Issue 9
Abstract
The analytical method has been developed to evaluate the efficacy of the cleaning procedure of all the equipment involved in the production of final active ingredients. The choice of the methodology is based upon the production method and on the intrinsic properties of the products. For this validation HPLC method has been chosen. The HPLC chromatographic separations were achieved on (100×4.6 mm), 3.5µm, column make:Phenomenex,employing acetonitrile and 0.4% orthophosphoric acid aqueous solution in the ratio of 35:65 as mobile phase with flow rate 0.7 mL/min was chosen. The column temperature was maintained at 30oC and a detector wavelength of 220 nm was employed. The method was successfully validated by establishing System Suitability, Specificity, Linearity, Accuracy, Limit of Detection and Limit of quantification for Ziprasidone HCl, Perindopril Erbumine, Venlafaxine HCl and Imiquimod. Keywords:HPLC, cleaning validation, Ziprasidone HCl, Perindopril Erbumine, Venlafaxine HCl, Imiquimod.
Authors and Affiliations
Tentu Nageswara Rao, N. Krishna Rao, Karri Apparao, A. Muralidhar Reddy
Keywords
Related Articles
- EP ID EP378115
- DOI -
- Views 105
- Downloads 0
Neuroprotective Effect of Clerodendrum serratum in Amyloid β(25-35) Induced Amnesia Mice
The content of the work is to determine the role of methanolic root extract of Clerodendrum serratum(CS) in amnesia induced mice by using β-amyloid peptide and compared with normal mice. The CS having anti-cancer, anti-h...
Development and Validation of RP-HPLC assay method for the Estimation of Dronedarone in bulk and Pharmaceutical Preparations
A rapid and reproducible reverse phase high performance liquid chromatographic method has been developed for the estimation of Dronedarone in its pure form as well as in pharmaceutical dosage forms. Chromatography was ca...
Efficacy of dexamethasone in prevention of trismus in mandibular third molar surgery
Abstract:Corticosteroids (dexamethasone and methylprednisolone) have been reported to control postoperative outcome when given preoperatively. The aim of study is to evaluate efficacy of dexamethasone in prevention of tr...
In vitro Cytotoxic Activity of Luffa acutangula on Human Neuronal Glioblastoma and Human Lung Adenocarcinoma Cell Lines
In vitro studies were carried out to evaluate the cytotoxic potential of the ethanolic and aqueous extracts of Luffa acutangula against human neuronal glioblastoma cells (U343) and human lung cancer cells (A549). Screeni...
Novel Topical Nanoformulations: An Overview
Abstract: Novel drug delivery system (NDDS) refers to the approaches, formulation, technologies and systems for transporting a pharmaceutical compound in the body as needed to safety achieve its desired therapeutically e...