Abstract

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING HPTLC METHOD FOR DETERMINATION OF EFAVIRENZ AS BULK AND IN CAPSULE DOSAGE FORM

Shriram S. Temgire, Padmanabh B. Deshpande*, Shraddha Jadhav

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Abstract

A new simple, accurate and precise stability-indicating high performance thin layer chromatography (HPTLC) method has been developed and validated for determination of Efavirenz as bulk drug and in capsule dosage form. The drug was exposed to hydrolytic, oxidative, thermal and photolytic stress conditions to check the stability nature of drug. Chromatographic resolution of Ebastine was accomplished by use of precoated silica gel 60 F254 aluminium plates as stationary phase and solvent mixture comprising of Toluene: Ethyl acetate: Methanol (8:5: 1: 0.5, v/v/v) as mobile phase. Densitometric detection was carried out at 247 nm. The retention factor was found to be 0.45 ±0.01. The developed method was validated with respect to linearity, accuracy, precision, limit of detection, limit of quantitation and robustness as per ICH guidelines. Results were found to be linear in the range of 200- 1200 ng band-1. The developed method has been successfully applied for the estimation of drug in capsule dosage form.

Keywords: Efavirenz, HPTLC, Stability Indicating Method, Validation, ICH.