ABSTRACT:
To develop a simple, selective and sensitive high performance thin layer chromatographic (HPTLC) method for the determination of Bromhexine hydrochloride in human plasma. The method had been validated for linearity, precision, accuracy and stability following US CDER guidelines for bioanalytical method validation. Sample was prepared by protein precepitation extraction technique using acetonitrile. Supernat was spotted on TLC plates precoated with silica gel 60 F254. Amoxicilin was used as an internal standard. The mobile phase consisted of a mixture of n- Butyl aceteate: Methanol:GAA: Water(HPL grade) in tha ratio of 5:2.5:2.5:1v/v/v/v. The drug showed considerable absorbance at 246 nm. The method was found to be linear over the concentration range of 20-120 ng/ band. Mean drug recovery was found to be 96.81%. Bromhexine hydrochloride in plasma samples was stable parameters as per US CDER guidelines. The method was found to be precise, accurate and can further be extented to pharmacokinetic studies for therapeutic drug monitoring of Bromhexine hydrochloride in routine clinical practices.