Professional Documents
Culture Documents
Research Article Analytical Chemistry
Research Article Analytical Chemistry
Research Article Analytical Chemistry
College Of Pharmacy, Kovai Medical Centre Research And Educational Trust, Coimbatore,641048,
India.
*Corresponding author
ABSTRACT
INTRODUCTION
Ambroxol hydrochloride1 is chemically, 1 ({[2 used in the treatment of utricaria and allergic
Amino 3, 5 dibromo phenyl] methyl} amino) rhinitis. . Literature survey showed that very
cyclohexanol monohydrochloride which is a few analytical methods have been reported
semi synthetic derivative of vasicine from the for the estimation of Loratidine and
Indian shrub Adhatoda vasica. It is an Ambroxol Hydrochloride individually and in
expectoration improver and a mucolytic agent combination with other drugs like uv-visible
used in the treatement of bronchial asthama spectrophotometry12, liquid chromatography
and chronic bronchitis. Ambroxol hydrochloride with flouroscence11 , LC-MS/MS5, RP-
has also been reported to have a cough LC13,capillary electrophoresis8, HPLC with
suppressing effect and anti inflammatory potentiometric detection2, etc. However, there
action. Recently the inhibition of nitric oxide is no uv method reported for the
dependent activation of soluble guanylate simultaneous estimation of these drugs in
cyclase was suggested one of the molecular combined dosage forms. fixed dose
mechanism of the therapeutic action of combination containing ambroxol
ambroxol hydrochloride, also used in hydrochloride (60mg) and loratadine (5mg)is
pulmonary alveolar proteinosis in pulmonary available in the tablet dosage form in the
distress and infant respiratory distress market.
syndrome. The objective of present study was
Loratidine13 is chemically 4-[8-chloro-5, 6- to develop simple, precise, accurate and
dihydro-11Hbenzo [5, 6] cyclohepta [1, 2-b] validated, economic and analytical methods
pyridin-11-ylidene]-1-piperidinecarboxylic acid for estimation of Ambroxol Hcl and Loratadine
ethyl ester with a potent antihistaminic agent in tablet dosage forms.
Structure of Loratadine:
Where A1 and A2 are absorbance of mixture by this method were calculated and found to
at308nm and 245nm respectively,ax1 and ax2 be outside the range of 0.1-2.0 which is
are absorptivities of ambroxol and loratadine at satisfied for both the ambroxol and loratadine
1 and 2 respectively.cx and cy are in ratios of 1:1 and 1:2.
concentrations of ambroxol and loratadine
respectively. Figure 1 represents the overlain RECOVERY STUDIES22-23:
spectra of both the drugs in 1:1 ratio and the
criteria for obtaininig maximum precision (i.e. The method was validated according to ICH
absorbance ratio (A2/A1)/ax2/ax1 and ay2/ay1) Q2B guidelines for validation of analytical
TABLE NO : 2
Determination of percentage recovery
10 10 99.370.43 99.041.20
20 20 100.930.90 99.660.63
30 30 100.250.78 99.871.38
S.D.* for standard deviation, the results of mean of three readings (n=3).
ACKNOWLEDGEMENT
The authors thank to M/s. Fracno Indian pharma, Mumbai for providing gift samples of loratadine
and ambroxol Hydrochloride.