Abstract
DEVELOPMENT AND VALIDATION OF SIMPLE AND SENSITIVE UV-VISIBLE SPECTROSCOPIC METHOD FOR ESTIMATION OF ACYCLOVIR IN BULK AND PHARMACEUTICAL DOSAGE FORM
Tanmay Dongaonkar*, Shubham Doifode, Om Kharde, Sudarshan Ugale and Prafulla Tathe
ABSTRACT
A simple, sensitive, accurate, novel, rapid, precise, reproducible and cost effective spectrophotometric method for the quantitative estimation of Acyclovir in bulk drug and pharmaceutical formulation and validated according to the ICHQ2 (R1) guideline. The acyclovir drug solution was scanned over UV-visible range for determining the wavelength at which the maximum absorbance is occurs. At wavelength of maximum absorbance of acyclovir various calibration standards of acyclovir were prepared and recorded the absorbance. The calibration curve of concentration vs. absorbance was plotted and linearity and range was calculated. Various analytical method validation parameters viz. accuracy, precision, limit of detection, limit of quantification, and ruggedness were calculated using QC standards. The maximum absorbance (? max) of acyclovir was found to be 253.2 nm. The drug obeyed beer lamberts’ law in the concentration range of 1-10 ?g/ml and the correction coefficient was 0.991 at 253.2 nm. The overall % recovery was taken at three level 80%, 100% and 120% which is found to be 99.69 to 100.89 %, 99.02 to 100.92% and 99.24 to 100.7% respectively, which reflects that the method was free from the interference of the impurities and other excipients used in the formulation. The low value of % RSD was indicative of accuracy and reproducibility of the method. The % RSD for inter-day and intra-day precision was found to be of 0.42 to 1.75 & 0.48 to 1.23 respectively which is < 2% which proved that method is precise. The results of analysis have been validated as per International Conference on Harmonization (ICH) guidelines. The developed method can be adopted in routine analysis of acyclovir in bulk dosage as well as form tablet dosage form.
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