A simple, precise, accurate and rapid high performance thin layer chromatographic method has been developed and validated for the simultaneous estimation of Levocetrizine dihydrochloride, Montelukast sodium and Ambroxol hydrochloride. in a combined capsule dosage form. The method was based on separation of three drugs on Merck aluminium plates precoated with silica gel 60 F254 using chloroform: methanol 9.3:0.7(v/v) as mobile phase. Quantitative analysis was performed by densitometric scanning at 206 nm. The three drugs were satisfactorily resolved with Rf values of 0.05, 0.52 and 0.21 mins for levocetirizine ,Montelukast and Ambroxol, respectively. The developed method was validated as per the ICH guidelines (Q2 R1). The method was found to be linear over concentration ranges of 800ââ?¬â??2400 ng/spot for Levocetirizine dihydrochloride, 100-700 ng/spot for Montelukast sodium and 600-1400 ng/spot for Ambroxol hydrochloride. Percentage recovery was found to be 99.46, 87.83 and 97.57 for Levocetrizine dihydrochloride, Montelukast sodium and Ambroxol hydrochloride respectively. The HPTLC method was successfully applied to the analysis of all the three drugs in a pharmaceutical tablet formulation. No chromatographic interference from the tablet excipients was seen in this method. The method developed can be used for routine analysis in bulk drug and capsule dosage form.
Loading....