Abstract

DEVELOPMENT AND VALIDATION OF ANALYTICAL PROCEDURES FOR THE SIMULTANEOUS ESTIMATION OF ACYCLOVIR AND ZIDOVUDINE THROUGH UV AND RP-HPLC METHODS

Jayendra Chunduru*, Pavankumar Chadalawada, Govada Kishore Babu and Srinivasa Babu Puttagunta

ABSTRACT

Combinatorial therapy involving Acyclovir and Zidovudine treats herpes-infected immunocompromised patients, offering enhanced efficacy and reduced risk of drug resistance compared to monotherapy. The primary focus of this study was to develop and validate a robust analytical procedure for the simultaneous determination of Acyclovir and Zidovudine using UV spectrophotometry and RP-HPLC methods. In the HPLC method, the mobile phase was optimized with a mixture of water, methanol, and acetonitrile in the ratio of 40:25:35 with 2% TEA, allowing for effective separation with retention times of 3.36 and 4.43 minutes for Acyclovir and Zidovudine, respectively, at a flow rate of 0.5 mL/min. The method exhibited excellent linearity, with correlation coefficients (R²) exceeding 0.996 for both drugs across the 2–10 μg/mL concentration range. The UV method, optimized at 253 nm for Acyclovir and 267 nm for Zidovudine, demonstrated similarlyhigh sensitivity, with LOQ values ranging from 1.29 to 1.55 μg/mL and LOD values between 0.42 and 0.51 μg/mL. System suitability testing confirmed the reliability of the methods, with capacity factors (k’) of 6.41 for Acyclovir and 7.87 for Zidovudine and signal-to-noise ratios (S/N) of 67.23 and 52.98, respectively. The validated methods are precise, accurate, and suitable for routine quality control, ensuring the reliable estimation of Acyclovir and Zidovudine in pharmaceutical formulations.

Keywords: Acyclovir, Zidovudine, Water, Methanol, Acetonitrile, UV and RP-HPLC Methods.