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Stability Indicating HPTLC Method Development and Validation for the Estimation of Pazopanib Hydrochloride in Bulk and its Dosage Form
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| Author:
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DR.PRASHANT D GHODE, PRIYANKA U. DHAIGUDE, SHIVAM P. RATHOD, DR. ATUL S SAYARE, ASAWARI D PACHAURI, DR.K R KHANDELWAL, DR.SHWETA P GHODE
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| Abstract:
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In this study, a simple, economical, rapid, precise and accurate stability indicating HPTLC method was developed and validated for estimation of Pazopanib hydrochloride in tablet dosage form. For development of chromatogram Ethyl acetate: Toluene: Methanol (5.5:4:0.5 v/v/v) was used as a mobile phase. The TLC plates used for chromatography as a stationary phase were aluminium plates precoated with silica gel 60F254. The densitometric scanning was performed at 270nm and separation occurred was found to be at Rf value of 0.42 ± 0.04. As per the ICH guidelines the method was validated for different parameters and good results were obtained. Linearity was found to be 200-1200ng/band for Pazopanib hydrochloride which indicates the good linear relationship. Regression equation obtained was y=7.9419x + 2348.7 and the R2was 0.994. All the results obtained from precision parameters were within the limits (%RSD Less than 2) which showed that the method was more precise. Percentage recovery was found to be in the range of 98% to 102%. The method was found to be robust as indicated by its results obtained below 2.0% RSD. LOD and LOQ values of the method were 0.26ng/band and 0.81ng/band respectively. Assay of the tablet dosage form was found to be 100.6%. In forced degradation study, the drug was sensitive to various stressed conditions such as acidic, alkaline, neutral, oxidative and thermal degradation whereas highly sensitive to photolytic degradation. Overall from this study we can conclude that the developed method can be used for the routine analysis of Pazopanib hydrochloride.
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| Keyword:
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HPTLC, Pazopanib hydrochloride, Stability indicating, Validation, Forced degradation
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| EOI:
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| DOI:
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https://doi.org/10.31838/ijpr/2020.12.03.518
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