Determination of terbutaline sulfate and its degradation products in pharmaceutical formulations using LC (original) (raw)
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The cleaning validation is to validate whether the cleaning procedure used at the liquid oral department can limit the drug residues to a predetermined acceptable level. The cleaning validation is to address the amount of crosscontamination, which is a major concern about multipurpose pharmaceutical formulation plants. This study addressed difficulties in swab recovery studies. The candidate drug, Terbutaline sulfate, is selected as per the MACO study employed in the liquid oral production line. Terbutaline sulphate has a MACO value of 131.25 mg, is found to contaminate more in the group. The HPLC method is developed and validated by using various method validation parameters like accuracy, precision, specificity, linearity and range, intermediate precision, and robustness. The recovery studies are carried out using a Texwipe swab made of the polyester tip. Swabbing time and swabbing pattern are developed and the method is validated by using the method validation parameters as menti...
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International Journal of Pharma Research and Health Sciences, 2014
The objective of present work was to develop and validate a simple,accurate,precise HPLC method for the estimation of doxofylline and terbutaline sulfate. The chromatographic separation was achieved on a Hypersil BDSC 18 column(4.6x250 mm,5μmparticlesize). Different mobile phase systems in different proportions were tried. For HPLC method a mobile phase consisting of Methanol and Acetonitrile (80:20) produced symmetric peak shape with good resolution for both the drugs. Next, the drugs were chromatographed under different flow rates from which a flow rate of 1.0 ml/min was selected. The retention times of Doxofylline and Terbutaline sulfate were found to be 2.869 min and 3.942 min,respectively.The proposed method was found to have excellent linearity in the concentration range of 20-80mg/ml with correlation coefficientr2=0.999 and 0.999 for Doxofylline and Terbutaline sulfate respectively.The method was validated for linearity,precision, LOD, LOQ and robustness.The proposed method optimized and validated as per ICH guidelines.
2016
International Journal of Pharmaceutical Sciences Review and Research Available online at www.globalresearchonline.net © Copyright protected. Unauthorised republication, reproduction, distribution, dissemination and copying of this document in whole or in part is strictly prohibited. 288 M. S. Althanyan, Abed-Al Nasser. H, Assi, B.J. Clark, K.H. Assi University of Bradford, Bradford BD5 0NZ, United Kingdom. *Corresponding author’s E-mail: k.h.a.assi@bradford.ac.uk
Spectrophotometric Determination of Salbutamol and Terbutaline using 9-Chloroacridine Reagent
Egyptian Journal of Chemistry, 2021
A simple and sensitive spectrophotometric method has been described for the assay of Salbutamol sulphate (SBS) and Terbutaline sulphate (TERS) in their pure and dosage forms. The method was based on the reaction of the nucleophilic compensation by interacting of drugs with the reagent 9-chloroacridine (9-CA) in basic medium. The products have absorption bands with maximum absorbance at 600 nm and 588 nm for SBS and TERS respectively. Beer’s law was obeyed in the range 0.5-12.0 μg.ml-1 and 0.1-6.0 μg.ml-1 with molar absorptivity values 1.913×104 and 1.0755×105 l.mol-1.cm-1, recoveries are 101.3% and 99.6% for above drugs respectively. The relative standard deviation (RSD) is less than 1.7% for both drugs. The probable reactions have been suggested.
2013
A fast, rapid, sensitive and stability indicating high-performance thin-layer chromatographic (HPTLC) method is developed and validated for quantitative estimation of terbutaline sulphate (TS), Guaiphenasin (G) and Bromhexine hydrochloride (B.HCl) simultaneously in pharmaceutical formulation (Cough Syrup). The sample are chromatographed on silica gel 60F254- TLC plates, using solvent system Dichloromethane: Methanol: Acetic Acid (7.5: 1:0.5) and scanned at 254nm. The current method demonstrates good linearity over the range for TS was 2001200ng/spot with r 2 of 0.999; G is 1.0-6.0mcg/spot with r 2 of 0.998 and B.HCl 500-3500ng/spot with r 2 of 0.997. The average recovery of the method is 100.47% for TS; 99.94% for G and 100.12% for B.HCl in formulation. The limit of detection and limit of quantification for TS, G and B.HCl were found to be 50-150ng/spot, 200-800ng/spot and 100-300ng/spot respectively. The developed method was successfully applied for the assay of market formulation....