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STABILITY INDICATING HPLC METHOD FOR SIMULTANEOUS DETERMINATION OF DIPHENHYDRAMINE PHENYLEPHRINE PARACETAMOL DIAZEPAM IN BULK AND TABLET DOSAGE FORM
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| Author:
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MANGA KUNA, GOWRI SANKAR DANNANA
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| Abstract:
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Novel stability indicating RP-HPLC method has been developed and validated for simultaneous estimation of Diphenhydramine, Phenylephrine, Paracetamol and Diazepam in bulk and dosage forms. The method involves separation on BDS column (250mm*4.6mm*5µm particle size). The optimized mobile phase consists of 0.1% Ortho phosphoric acid and Acetonitrile (70:30 v/v) with a flow rate of 1 ml/min and UV detection at 211 nm. Retention time was 2.309 min for Diphenhydramine, 2.898 min for Phenylephrine, 3.304 min for Paracetamol and 9.769 min for Diazepam. RP-HPLC method for the simultaneous estimation of Diphenhydramine, Phenylephrine, Paracetamol and Diazepam in their combined dosage form was developed and validated as per the ICH guidelines. Linearity was observed in the range of 12.5-75µg/ml for Diphenhydramine, 6.25-37.5µg/ml for Phenylephrine, 125-750µg/ml for Paracetamol and 5-30µg/ml for Diazepam with correlation coefficients (r2=0.999). The percentage recoveries of Diphenhydramine, Phenylephrine, Paracetamol and Diazepam were in the range of 98.92-101.54% which was within the acceptance criteria. The %RSD was not more than 2% which proved the precision of the developed method. When applied for tablet assay, drug content was within 98.92-101.54% of labelled content. Forced degradation studies indicated the suitability of the method for stability studies.
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| Keyword:
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Diphenhydramine, Phenylephrine, Paracetamol, Diazepam
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| EOI:
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| DOI:
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