Analytical Method Development and Validation for Estimation of Poly (Hexamethylene Biguanide) Hydrochloride in Marketed Formulation

The objective of this study was to establish a reasonably simple and reliable method to estimate Poly (hexamethylene biguanide) hydrochloride [PHMB] in marketed formulation. New methods like UV & HPTLC were developed for estimation of Poly (hexamethylene biguanide) hydrochloride with all the validation parameters within range. Both the methods were developed and validated as per regulatory guidelines. UV method was developed in Water as a solvent. Linearity was found to be 2-12μg/ml for Poly (hexamethylene biguanide) hydrochloride. The method was found to be accurate, precise according to acceptance criteria. The proposed UV method can be applicable for the estimation of the drug in marketed formulation. HPTLC method was developed using mobile phase Methanol:O-phosphoric acid (10: 0.5 %v/v). In HPTLC method linearity was found 2000-12000ng/spot for Poly (hexamethylene biguanide) hydrochloride. HPTLC method was found to be simple, accurate and precise. The developed HPTLC method can be applicable for the estimation of the drug in marketed formulation. Developed methods can be applied in routine analysis for the estimation of Poly (hexamethylene biguanide) hydrochloride in marketed formulation.