Abstract

Vivek Tiwari^1* and S.K. Mishra²

DOI : http://dx.doi.org/10.13005/ojc/370423

A high-performance liquid chromatographic stability-indicating assaymethod in reverse-phase has been developed and validated for the simultaneous qualitative and quantitative measurement of triamcinolone acetonide and benzyl alcohol content in injectable suspension. The reverse-phase method was developed by using Inertsil ODS-2 column(100 x 4.6mm),5μm. with a mobile phase ratio comprised of water and acetonitrile mixed in 70:30 v/v ratio and pumped at a flow rate of 1.5 ml/min where the temperature of the column oven controlled at 40°C and sample compartment at 5°C with 10μL injection volume. Benzyl Alcohol and Triamcinolone Acetonide had retention times of 1.80 and 5.60 minutes, respectively with UV detection for benzyl alcohol at 215 nm and triamcinolone acetonide at 254 nm. The guidelines of the International Conference on Harmonization were used for the validation of this novel method. During validation, the developed approach was shown to be exact, accurate, linear, robust, rugged, and stable. The detector was showing linear response in a range of 10 µg/mlto 120 µg/ml and 2.5 µg/ml to 30 µg/ml for triamcinolone Acetonide and benzoyl alcohol respectively.

Benzyl alcohol; Development; ICH; Stability indicating; Triamcinolone acetonide; Validation

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