Stability Indicating HPTLC Method Development and Validation for Simultaneous Estimation of Polmacoxib and Paracetamol in Bulk and tablet dosage form
Abstract
Abstract A simple, accurate, reliable, precise and robust HPTLC method was designed for the simultaneous determination of Polmacoxib (POL) and Paracetamol (PCM) in bulk drug and dosage form. Chromatographic separation was performed on silica gel 60 F 254 plates with a mobile phase of toluene:ethyl acetate:formic acid (5:4:1, v/v/v) and detected densitometrically at 283 nm. POL and PCM were shown to have retention factors (Rf) of 0.66 and 0.50, respectively. With correlation values greater than 0.999, the approach demonstrated excellent linearity over concentration ranges of 80–240 ng/band for POL and 13000–39000 ng/band for PCM. Specificity, accuracy, precision, robustness, sensitivity, LOD, and LOQ were all satisfactory when validation was carried out in accordance with ICH recommendations. Forced degradation studies performed in acidic, alkaline, oxidative, neutral, thermal, and photolytic conditions which confirmed the stability indicating capability of method. It was discovered that the established HPTLC approach was appropriate for regular quality control and stability analysis of polmacoxib and paracetamol in pharmaceutical formulations.
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