Analysis Of Acyclovir Research Articles

Analytical Quality by Design (AQbD) Approach to Liquid Chromatographic Method for Quantification of Acyclovir and Hydrocortisone in dosage forms

Analytical quality by design (AQbD) based high performance liquid chromatographic (HPLC) method for routine analysis of acyclovir and hydrocortisone in dosage form has been developed on C18 column using experimental design. Central composite design (CCD) was adopted in assessment of method responses and robustness. In experimental design, resolution (Y1) and separation factor (Y2) were tested method critical parameters such as pH (X1), % aqueous in mobile phase (X2) and flow rate (X3). Two models for retention time (Y1) and separation factor (Y2) were obtained and then interpreted statistically. Chromatographic optimum range for each input variable (Xn) was obtained through analysis of constructed models and contour plots. The predicted data from response models for resolution time (Y1) and separation factor (Y2) were statistically significant. Then, these variables were used in verification of method performance characteristics such as accuracy and precision within the method operable range for robustness. The robustness behavior of the method was verified at different points and the result was good with more than 40 % of aqueous phase (X2) at pH of 6.0 (X1) at a flow rate of 0.9 ml min-1 (X3). The method has proven and suitable for regulatory flexibility.

A newfangled study using risk silhouette and uncertainty approximation for quantification of acyclovir in diverse formulation

Risk assessment and uncertainty approximation are two major and important parameters that need to be adopted for the development of pharmaceutical process to ensure reliable results. Additionally, there is a need to switch from the traditional method validation checklist to provide a high level of assurance of method reliability to measure quality attribute of a drug product. In the present work, evaluation of risk profile, combined standard uncertainty and expanded uncertainty in the analysis of acyclovir were studied. Uncertainty was calculated using cause-effect approach, and to make it more accurately applicable a method was validated in our laboratory as per the ICH guidelines. While assessing the results of validation, the calibration model was justified by the lack of fit and Levene׳s test. Risk profile represents the future applications of this method. In uncertainty the major contribution is due to sample concentration and mass. This work demonstrates the application of theoretical concepts of calibration model tests, relative bias, risk profile and uncertainty in routine methods used for analysis in pharmaceutical field.

HPLC DETERMINATION OF ACYCLOVIR AND ZIDOVUDINE IN MATERNAL PLASMA, AMNIOTIC FLUID, FETAL, AND PLACENTAL TISSUES USING ULTRA-VIOLET DETECTION

ABSTRACT A sensitive and reproducible HPLC assay has been developed and validated for the separation and analysis of acyclovir and zidovudine from plasma, amniotic fluid, placental homogenate, and fetal homogenate. Acyclovir (9-[(2-hydroxyethoxy)-methyl]-guanosine, ACV) is the oldest and most widely used compound to treat episodes of genital herpes (herpes simplex virus-2, HSV-2). Zidovudine (3-azido-3′deoxythymidine, AZT) is the premier reverse transcriptase inhibitor released for the treatment of human immunodeficiency virus (HIV). Both of these drugs have been used in pregnant women to prevent the vertical (mother-to-child) transmission of their respective viruses. This gradient HPLC assay aids in the quantitation of these drugs from the matrices associated with pregnancy (maternal plasma, amniotic fluid, fetal tissue, and placenta). The mobile phase consists of 30 mM acetate/ citrate buffer ( pH 3) and methanol. The plasma and amniotic fluid samples are prepared using a combination of protein precipitation and filtration, while the more complex tissues are prepared with the use of a solid-phase extraction (SPE). The method was validated in the calibration range of 0.1–100 μg/mL and showed precision (%Relative Standard Deviation; %RSD) and accuracy (%Error) of less than 15% for all matrices over three days. The assay was applied to a pharmacokinetic study involving the co-administration of ACV and AZT in the pregnant rat.

Analysis of acyclovir by high performance capillary electrophoresis with on-column amperometric detection.

The separation of acyclovir (ACV) by high performance capillary electrophoresis (HPCE) with on-column amperometric detection using alpha-amino-5-mercapto-3,4-dithiazole (AMD) as internal standard is described. The calibration line was linear in the range of 0.5-20 mg/L of ACV. The detection limit was 0.15 mg/L of ACV. Its recovery ranged from 98 to 101% with relative standard deviations (RSDs) from 1.9 to 3.2% (n = 5). This method was successfully used for determining ACV in some pharmaceuticals and human urine. Comparable results with HPCE with ultraviolet (UV) detection and amperometric detection were obtained.