Abstract

DEVELOPMENT AND VALIDATION OF NEW ANALYTICAL METHODS FOR THE DETERMINATION OF ROXITHROMYCIN IN BULK AND PHARMACEUTICAL FORMULATIONS BY UV-VISIBLE SPECTROPHOTOMETRY

Swapna.G*, Manoj Kumar.T

ABSTRACT

In developing these methods, a systematic study of the effects of various relevant parameters in the methods concerned were undertaken by varying one parameter at a time and controlling all other parameters to get maximum color development, minimum blank color, reproducibility and the reasonable period of stability of final colored species formed. Method 1:A standard solution of roxithromycin of concentration of 1mg/ml was prepared in the 0.1N Hcl and then the absorbance studies were conducted for the solutions by using the uvvisible spectrophotometry. Solvent: Distilledwater, Reagents:0.1N Hcl Wavelength:205nm, Concentration range:2-10μg/ml, In this method, the spectra recorded was very nice and absorbance values gave good linearity. Here the range is extended upto 10μg/ml. Method 2: A standard solution of roxithromycin of concentration of 0.1mg/ml was prepared in F C reagent of 1.2ml was taken in the 0.1N Hcl and then the absorbance studies were conducted for the solutions by using the UV-Visible spectrophotomnetry . water and then the absorbance studies were conducted for the solution by using uv-visible spectrophotometry. Solvent: Distilledwater, Reagents:FcReagent,0.1NHcl Wavelength:410nm ,Concentration range:1-5μg/ml.In this method the spectra recorded was very nice and absorbance values gave good linearity.Here the range is extended upto 5μg/ml. Method 3: A standard solution of roxithromycin of concentration of 0.1mg/ml was prepared in water and solution of MBTH of concentration 0.1mg/ml was prepared in the Ferric chloride and conc.HCl then the absorbance studies were conducted for the solutions by using uv-visible spectrophotometry. Solvent: Distilled water Reagents: MBTH in the Ferric chloride and conc.HCl Wave length:410nm, Concentration range:2-10μg/ml.In this method the spectra recorded was very nice and the absorbance values gave good linearity, Here the range is extended up to 10μg/ml. Method 4: A). Acid –Base Titration method:0.1N Hcl and 0.1N NaoH 0.1 N Hcl: 4-2ml of Hcl in 500ml of water. 0.1N NaoH: 2gm of NaoH in 500ml of water. B) Non Aqueous Titrations: 0.1N Perchloric Acid: Mix 8.5ml of Perchloric Acid With 500ml of glacial acetic acid ,30ml of aceticanhydride,poor and add glacial acetic acid make 1000ml .Allow the solution stand for 24hrs.The aceticanhydride reacts with water and perchloric acid and acetic acid and renders the mixture virtually anhydrous. The absorption curves of colored species formed in each method shows characteristic absorption maximum; where as the blank in each method has low or no absorption in this region .In developing these methods, a systematic study of the effects of various relevant parameters validate this method according to ICH Q2 (B) to get a suitable method which meets the regulatory requirements. In the methods concerned were undertaken by varying one parameter at a time and controlling all other parameters to get maximum color development, minimum blank color, reproducibility and the reasonable period of stability of final colored species form

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