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Forced degradation studies and validated stability ΓΆΒ?Β? indicating HPTLC method for determination of miconazole nitrate in soft lozenges | Abstract
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Abstract

Forced degradation studies and validated stability ΓΆΒ?Β? indicating HPTLC method for determination of miconazole nitrate in soft lozenges

Author(s): Prashant K. Pagare, Chandrakant S. Satpute, Varsha M. Jadhav, Vilasrao Kadam

Recently, Polyethylene glycol (PEG) has potentially been utilized as a matrix component prepared with fusion and mold method as an inert carrier to improve the solubility of poorly water-soluble drugs. [1, 2, 3] Miconazole Nitrate Soft Lozenges were prepared by Melting and Mold method and investigated for various analytical parameters. A New, Simple, Precise, Rapid and Selective Stability – Indicating High - Performance Thin - Layer Chromatographic (HPTLC) method for the quantification of Miconazole nitrate (MCN) in the prepared Soft Lozenges has been developed. It was performed on silica gel 60 GF254 Thin Layer Chromatographic plates using mobile phase comprising of Toluene: Chloroform: Acetonitrile: Ammonia (4.5:4:2.5:0.2 v/v/v/v) and the detection was carried out at 226 nm using densitometer. The Retention Factor (Rf) was found to be 0.45 for MCN. The linear regression analysis data for the calibration plots showed good linear relationship with r2 = 0.9982 in the concentration range 4 - 60 μg /spot with respect to peak area. According to the ICH guidelines the method was validated for Linearity, Specificity, Recovery, Precision, Robustness, Limit of Detection (LOD) and Limit of Quantification (LOQ). Forced Degradation Studies were carried out on Miconazole Nitrate as per ICH Guidelines. [4] Statistical analysis of the data showed that the method is reproducible and selective for the estimation of Miconazole Nitrate.


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