UV- SPECTROPHOTOMETRIC METHOD DEVELOPMENT FOR THE DETERMENATION OF PARACETAMOL AND DROTAVERINE HYDROCHLORIDE IN COMBINATION TABLET DOSAGE FORM BY SIMULTANEOUS EQUATIONS METHOD
Rambabu.CH*, V. V. V. S. P. Apparao, Miss. M. Muthulakshmi, V. Ananth.
aPG-Student, Department Of Pharmaceutical Analysis,
KMCH College of Pharmacy,
Kalapatti Road, Coimbatore– 641 048, INDIA.
At present, simultaneous determination of drugs in the combination dosage forms has been enjoying renaissance in the field of pharmaceutical analysis. Paracetamol, a classical antipyretic in combination with a novel antispasmodic drug, drotaverine hydrochloride provides a synergistic effect in the treatment of spasms. From the reviewed literature, it was simultaneous uv-spectrophotometric methods have not yet been developed for the determination and quantification of paracetamol and drotaverine hydrochloride. The λmax of paracetamol is 257 nm and that of drotaverine hydrochloride were scanned and found to be 308 nm, 352 nm. Both paracetamol and drotaverine hydrochloride were found to have significant absorbance of the λmax of each other and total absorbance was equal to the sum of the absorbance of paracetamol and drotaverine hydrochloride individually measured. So the present study involves the uv-spectrophotometric method development for the simultaneous determination of paracetamol and drotaverine hydrochloride by using simultaneous equations method. The mean % recoveries from this method were found to be 100.76% and 100.17% for paracetamol and drotaverine hydrochloride respectively proving that the method is accurate.
REFERENCE ID: PHARMATUTOR-ART-1471
Paracetamol chemically known as N-(4-Hydroxyphenyl) acetanilide is an effective classical antipyretic drug1, drotaverine hydrochloride chemically known as 1-(3, 4-diethoxy benzylidene)-6, 7-diethoxy, 1, 2, 3, 4 tetra hydro isoquinoline is a newer antispasmodic drug2,3. The novel combination both paracetamol and drotaverine hydrochloride has synergistic antispasmodic activity.
From the literature reviewed it was found that only individual determination of paracetamol and drotaverine hydrochloride4 or simultaneous determination of paracetamol along with other drug using UV-Spectrophotometry, HPLC, Electrochemical method etc5,6,7 were available. However, simultaneous determination of paracetamol and drotaverine hydrochloride in combined tablet dosage form by simultaneous equations method using UV-Spectrophotometry was not yet been developed so far which is the present method of interest.
2. Aim and objective:
The combination of Drotaverine and paracetamol are used as an anti spasmodic agent. Paracetamol is an official drug. But Drotaverine is not an official drug. Survey of literature of paracetamol either single or in combination with other drugs revealed several methods based on spectrophotometry and chromatography. But Drotaverine in combination with paracetamol revealed the reverse phase HPLC, first order derivative spectroscopy absorbance ratio method of UV-spectrophotometry. Not a single method has yet been reported for simultaneous determination of both the drugs in combined dosage form.
The raw materials of Paracetamol and drotaverine hydrochloride were obtained as gift samples. The Paracetamol and drotaverine hydrochloride combined tablet dosage form was commercially bought from the local market.
No reagents, other than double distilled water was used.
3.3. Identification Tests
i. Melting point - The m.p of Paracetamol was found to be 172oc
The m.p of Drotaverine HCl was found to be 210oc
ii. FT-IR (Fourier transform infrared spectrophotometer):-
IR spectra for standard paracetamol, Drotaverine HCl and mixed standards are interpreted as follows in table 7 (a), 7 (b) & 7 (c).
IR is used for the determination of functional group present in the molecule.
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