METHOD DEVELOPMENT AND VALIDATION OF ATAZANAVIR IN PHARMACEUTICAL FORMULATION BY RP-HPLC METHOD
Journal Title: Int J of Pharm Res & Analy - Year 2015, Vol 5, Issue 1
Abstract
Present work describes method for determination of Atazanavir in solid dosage form. The estimation was carried out on a Waters ODS (C18) RP Column, 250 mm x 4.6 mm.column with a mixture of Buffer (triethylamine & pH adjusted to 3.0 with glacial acetic acid) and Acetronitrile in a ratio of 80 : 20(v/v) as mobile phase. UV detection was performed at 212 nm. The method was validated for linearity, accuracy, precision, specificity, limits of detection and quantitation and robustness as per ICH norms. The developed and validated method was successfully used for indicating the stability of the drug and quantitative analysis of commercially available dosage form. The retention time was 3.1min. The flow rate was 1.0 mL min-1. The calibration curve was linear in the range of 10-100 μg/ml, for Atazanavir (API) with correlation coefficient (r2) of 0.998. The LOD and LOQ values were found to be 0.05 g/ml and 0.15 g/ml. The high percentage of recovery and low percentage coefficient of variance confirm the suitability of the method for the estimation of Atazanavir in pure and in capsule dosage form.
Authors and Affiliations
Nazia Hasan*, , Shyamala, , JVC Sharma , P Vishnu Priya
Keywords
Related Articles
- EP ID EP95727
- DOI -
- Views 128
- Downloads 0
A SENSITIVE RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF ATORVASTATIN CALCIUM, FENOFIBRATE, AND ORLISTAT IN TABLET DOSAGE FORM
A simple, sensitive and reproducible method was developed and validated for the simultaneous estimation of Atorvastatin calcium, Fenofibrate, and Orlistat in tablet formulation by reverse phase high performance liq...
A REVIEW ON ANALYTICAL METHOD DEVELOPMENT AND VALIDATION
Analytical methods development must be validated to provide reliable data for regulatory submissions. Method development is the process of proving that an analytical method is acceptable for use to measure the concentrat...
DEVELOPMENT AND VALIDATION OF FIRST ORDER DERIVATIVE UV SPECTROPHOTOMETRIC METHOD FOR THE ESTIMATION OF TENOFOVIR DISOPROXIL FUMARATE, LAMIVUDINE AND EFAVIRENZ IN BULK AND TABLET DOSAGE FORM
A simple, sensitive, rapid, economic and accurate first order derivative spectrophotometric method has been developed for estimation of Tenofovir disoproxil fumarate (TDF), Lamivudine (LAM) and Efavirenz (EFV) and...
ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF SIMULTANEOUS ESTIMATION OF RUPATADINE FUMARATE AND MONTELUKAST SODIUM BY RP-HPLC
A sensitive, selective and precise high performance liquid chromatographic method has been developed and validated for the simultaneous determination of Rupatidine fumarate and Montelukast sodium in tablet dosage form. T...
GLYCAEMIC REGULATORY PROPERTIES OF SRI LANKAN LOW GROWN ORTHODOX ORANGE PEKOE BLACK TEA (Camellia sinensis)
This study examined the glycaemia regulatory potential of Sri Lankan low grown orthodox Orange Pekoe (O.P.) grade black tea brew (BTB) which was made according to ISO 3103 specifications. Different doses of BTB [223 (equ...