Development and validation of Polyhexa methylene guanidine HCL in its bulk and dosage form by RP- HPLC

Author(s)	H. Padmalatha
Country	India
Abstract	A simple, precision and accuracy HPLC method was developed the estimation of Polyhexa methylene guanidine analysis of formulation, consisting of an Methanol: water (60: 40 % v/v). The chromatographic condition was set at a Flow rate of 1 ml/min with the UV detector at 240 nm. The above method was optimized with a view to develop an assay method for Polyhexa methylene guanidine. Several mobile phase compositions were tried to resolve the peaks of Polyhexa methylene guanidine. The optimum mobile phase containing methanol: water (60: 40 % v/v) was selected because it was found ideal to resolve the analyte peaks of the drug. Quantification was achieved with UV detections at 240 nm based on peak area and absorbence. As per USP requirements system suitability studies were carried out and freshly prepared standard solutions of Polyhexa methylene guanidine.
Keywords	Polyhexa methylene guanidine, RP‐HPLC, Method development, Validation.
Field	Medical / Pharmacy
Published In	Volume 16, Issue 4, October-December 2025
Published On	2025-11-07
DOI	https://doi.org/10.71097/IJSAT.v16.i4.9244
Short DOI	https://doi.org/g99qkn

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