FORCED DEGRADATION STUDY OF POST-SHELF LIFE AND MARKETED TABLETS OF ZOLMITRIPTAN BY RP-HPLC
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Author:
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DR.VIDYASAGAR CHANDRAMANAIDU, C.SRINIVASULU
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Abstract:
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The stability of pharmaceutical products plays an important role from the economic point of view. There are not many studies that report about the stability of drugs past their expiration dates. The objective of the current study was to determine the tablet content of expired tablets of Zolmitriptan where expiry date has not exceded and to develop simple,accurate,sensitive and stability indicating RP-HPLC method for the determination of per cent drug remained of Zolmitriptan in the presence of its degradation products in bulk drug,expired tablets and tablets whose expiry date has not been exceeded.Drug was subjected to all stress conditions such as hydrolysis(acidic and alkaline),oxidation,photolysis,thermal degradation and humidity study.Content determination was performed using RP-HPLC method,the per cxent of dissolved substance from tabletswas also performed.All stressed samples were successfully analysed on C18 column using mobile phase acetonitrile: methanol: 0.1% orthophosphoric acid 69:29:2 (v/v/v) mobile phase (pH5.1).A flow rate was maintained at 1.5 Ml/mim and detection was made at 210nm.The proposed method was validated with regard to linearity,sensitivity and accuracy and precision.No discrepencies between the results of determination and the declared values range for all the analysed tablets were observed.The results of performed study might suggest that storage of analysed batches of tablets over time period exceeding the expiry date given by the manufacturer did not influence their contents
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Keyword:
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Zolmitriptan,Stability,Expired Tablets,RP-HPLC
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EOI:
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DOI:
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