Journal of Pharmacy Research Vol.4.Issue 11.November 2011 Hanimi Reddy Bapatu et al. / Journal of Pharmacy Research 2011,4(11),4117-4122 4117-4122
Research ArticleISSN: 0974-6943
Available online throughwww.jpronline.info
Hanimi Reddy Bapatu H. No: 4-22-51/25, Koritepadu, Guntur, Pin No: 522 007, Andhra Pradesh, India.
Tel.: + 91-
Each 5 mL syrup containsAmbroxol hydrochloride IP: 20 mgTerbutaline sulphate IP: 1.25 mgGuaiphenesin IP: 50 mg
-receptor agoinst.It helps the relaxation of the smoothmuscle found principally in bronchial, vascular and uterine tissue; wheezing andshortness of breathe troubled breathing caused by asthma, chronic bronchitis,emphysema and other lung diseases. Terbutaline has little effect on ß
receptors;thus direct cardiovascular stimulation occurs. However, terbutaline should beused carefully in cats with pre-existing cardiac disease, such ascardiomyopathy.Terbutaline use during pregnancy is associated with development of autisminhumans. Terbutaline side effects are drowsiness and headaches, increasedheart rate, diabetes, anxiety and worsening breathing problems.
is also called as guaifenesin
. It is used to reduce chest con-gestion caused by the common cold, infections, or allergies, including medical,veterinary, and personal, women to facilitiate conception by thinning and in-creasing the amount of cervical mucus, treatment of primary dysmenorrhea
Guaifenesin may cause side effects, headache, nausea and vomiting.
is an active mucolytic agent. Ambroxol is used in the treatment of respiratory diseases, pain relief in acute sore throat
. Ambroxol is a verypotent inhibitor of the neuronal Na+ channels.Chemical structures of all ingredients were represented in figure-1.All threeingredients are available in liquid pharmaceutical dosage forms.
Stability indicating RP-HPLC method for the determination of Terbutaline sulphate,Guaifenesin, Ambroxol hydrochloride and preservatives content in liquid formulations
Hanimi Reddy Bapatu
, Maram Ravi Kumar
, Useni Reddy Mallu
, Hari kishan Reddy Ganthi
,Chandra Mohan Rao Kota
and Viswanath Reddy Pyreddy
Department of Chemistry, JNT University, Kukatpally, Hyderabad, AP, India-500072.
AR&D, Custom Pharmaceutical Services, Dr. Reddys Laboratories Ltd, Bachupally, Hyd-72, India.
Department of Chemistry, Sri Krishnadevaraya University, Anantapur, AP, India-515003.
Ideal College of Arts and Sciences, Kakinada, East Godhavari, AP, India-533464.
Received on: 19-05-2011; Revised on: 08-06-2011; Accepted on:01-07-2011
To develop a single RP-HPLC method for determination of Terbutaline sulphate, Guaifenesin, Ambroxol hydrochloride and preservatives (methylparaben and propyl paraben) contents in liquid formulation.
Chromatographic separation was achieved on a Sunfire C18, 250 x4.6mm, 5µ column.Mobile phase composed of Sol-A: phosphate buffer (0.01M Potassium dihydrogen orthophosphate buffer pH 6.0± 0.1) and Sol-B: Acetonitrile with a simplegradient program (0-5min, sol-A:87-87; 5-10min- sol-A:87-80; 10-20min- sol-A:80-50; 20-25min- sol-A:50-50, 25-30min- sol-A:50-87and 30-35min- sol-A:87-87). 1.0ml per min flow rate and detection was at 214 nm.
High resolution was achieved with the simple gradient program and retention time of terbutaline sulphate, Guaifenesin, methyl paraben, ambroxol hydrochloride and propyl paraben are about 3.68min, 15.17min, 18.71min, 23.27min and 24.38min,respectively. The area of all ingredient peaks were a linear function of concentration in the range 98.7 to 296.1 ppm for Ambroxol hydrochloride, 6.2 to 18.6ppm for Terbutaline Sulphate, 246.4 to 747.3 ppm for Guaifenesin, 44.0 to 136.1 ppm for Methyl paraben and 5.5 to 14.6 ppm for Propyl paraben and thecorelation co-efficient value of all active ingredients within the limit (0.999).
Proposed gradient HPLC method was validated with specificity,linearity, accuracy, reproducibility ruggedness and it is applicable for regular analysis.
Terbutaline sulphate, Guaifenesin, ambroxol, Methyl paraben, Propyl paraben, Liquid formulations and RP-HPLC method.
Ambroxol hydrochlorideMethyl parabenTerbutaline sulphateGuaifenesin Propyl parabenFigure-1: Chemical structure of all ingredients
All ingredients have reported methods for individual and other combinationproducts
and there is no method reported for the simultaneous estimation of Terbutaline Sulphate, Guaifenesin, Ambroxol hydrochloride, methyl parabenand propyl paraben in combined liquid dosage forms. The objective of thepresent study is to develop a single RP-HPLC method for the estimation of Terbutaline Sulphate, Ambroxol hydrochloride, Guaifenesin and preservatives inliquid formulation.
MATERIALS AND METHODSSelection of mobile phase:
Various buffer salts, pH values were tried with different organic solvents (aceto-nitrile or methanol) for the optimization of mobile phase. Finally well shapedand high resolution was achieved with pH 6.8 phosphate buffer and acetonitrilewith gradient program.
Chemicals and reagents:
Potasssium di hydrogen orthophosphate, triethyl amine (AR Grade) were pro-