RP-HPLC and UV Method Development and Validation of Acyclovir in Bulk and Ointment Formulation
Sushma G Panchal1, Arunadevi S Birajdar2*, Sayali S Pawar3, Supriya S Shendge1, Amol A Joshi4
1Assistant Professor, K. T. Patil College of Pharmacy, Osmanabad, Maharashtra, India
2Associate Professor, K.T. Patil College of Pharmacy, Osmanabad, Maharashtra, India
3Student, ASPM’s K. T. Patil College of Pharmacy, Osmanabad, Maharashtra, India
4Principal, K. T. Patil College of Pharmacy, Osmanabad, Maharashtra, India
*Corresponding Author: Arunadevi S Birajdar, Associate Professor, K.T. Patil College of Pharmacy, Osmanabad, Maharashtra, India.
May 30, 2022; Published: July 21, 2022
The aim of the work is to develop Analytical Method Development and Validation for Assay of Acyclovir Ointment by UV-Visible method and reverse phase high performance liquid chromatographic method for the estimation of Acyclovir in bulk and ointment formulation and validation of developed method according to ICH Q2(R1) guidelines. According to USP 2010 Analytical method development was started with preliminary studies of the Acyclovir. The Stock Solution of the drug was prepared in Acetonitrile and Water because drug freely soluble in acetonitrile. The RP-HPLC method for estimation of Acyclovir dosage form was developed. by using Phenomenex Kientex C18 column (150 mm × 4.6 mm, 5 mm) as stationary phase and Mobile Phase A - 1% Acetonitrile: 99% Phosphate Buffer pH 3.1 and Mobile Phase B: 50% Acetonitrile: 50% Phosphate Buffer pH 2.5 as mobile phase. Mobile phase was maintained at a flow rate of 1.0 ml/min the quantification was carried out. The UV detector was operated at 254 nm at 30oC and Acyclovir eluted at RT 15.01 min. ACY was scanned by using UV-Vis spectrophotometer within 200-400 nm. The lambda max was found to be 254 nm, which was used for UV-Vis analysis of ACY. The study method was found to be precise, linear, accurate, robust, specific, stability indicating and suitable for its intended use. The developed method was validated according to ICH guidelines.
Keyword: Analytical Method Development; Validation; Assay; ICH Guidelines
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