Nizam Patel
1, Vijaykumar Kunvarji Parmar
1*1 Ramanbhai Patel College of Pharmacy, Charotar University of Science and Technology, CHARUSAT Campus, Changa – 388421, Ta. Petlad, Dist. Anand, Gujarat, India.
Abstract
Background: A sensitive high-performance thin layer
chromatographic (HPTLC) method was developed for simultaneous determination of
beclomethasone dipropionate and salbutamol sulphate from inhalation product.
Methods: Chromatographic separation was achieved on aluminium
plates pre-coated with silica gel G60 F254 as the stationary phase and
methanol:ethyl acetate:toluene:ammonia (3:1:3:0.15) as the mobile phase. The
densitometric evaluation was carried out at 232 nm. The developed method was
validated as per the ICH Q2 (R1) guidelines. Robustness of the proposed method
was assessed using experimental design approach, and results were analyzed
graphically. The results of sample analysis by proposed HPTLC method and
reported HPLC method were statistically compared.
Results: The Rf value of salbutamol sulphate
and beclomethasone dipropionate was found to be 0.38±0.02 and 0.72±0.02,
correspondingly. The response in terms of peak area was linear over the
concentration range of 100-500 ng/spot and 200-1000 ng/spot for beclomethasone
dipropionate and salbutamol sulphate, individually, with the regression
coefficient values greater than 0.99 for both the drugs. The limit of detection
and limit of quantification for beclomethasone dipropionate were found to be 27
ng/spot and 84 ng/spot, respectively and for salbutamol sulphate were 40
ng/spot and 112 ng/spot, respectively. The proposed method was found to be
statistically insignificant when compared to the reported method.
Conclusion: The proposed method is robust, sensitive, accurate
and precise. The method can be applied for the simultaneous estimation of
beclomethasone dipropionate and salbutamol sulphate from inhalation product.