Pharmaceutica Analytica Acta

Abstract

HPTLC-Densitometric and RP-HPLC Method Development and Validation for Determination of Salbutamol Sulphate, Bromhexine Hydrochloride and Etofylline in Tablet Dosage Forms

Ankit Tyagi, Nitin Sharma, Karan Mittal, Rajashree Mashru, Tilakraj Bhardwaj, Jai Malik and Arti Thakkar

Different HPTLC-densitometric and RP-HPLC methods are developed for the simultaneous determination of salbutamol sulphate, bromhexine hydrochloride and etofylline in pharmaceutical tablets. HPTLC method was based on separation of all three drugs followed by densitometric measurements of their spots at 275 nm using CAMAG, TLC scanner III. The separation was carried out on Merck HPTLC aluminium plates of silica gel 60 F254, using acetone: methanol: formic acid (9:3:0.01) as mobile phase at room temperature (25 ± 2°C). The HPLC separation was carried out using a mobile phase consisting of 0.02 M ammonium acetate buffer: organic phase (where organic phase MeOH: ACN in ratio of 70:30) adjusted to pH 4.5 with gradient elution. The column used was Waters Spherisorb®C18 bonded with 5 μm (4.6 x 250 mm) with a flow rate of 1 mL min-1 and UV detection at 275 nm simultaneously. The mean recovery ofboth HPTLC and HPLC methods were found to be within 99.44 to 99.85 % w/w. Both HPTLCdensitometric and RP-HPLC methods were statistically validated and can be used for analysis of combined dose tablet formulation containing salbutamol sulphate, bromhexine hydrochloride and etofylline.