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Inventi Rapid: Pharm Analysis & Quality Assurance
publication date: 2011/7/1

VALIDATED RP-HPLC METHOD FOR THE ESTIMATION OF MISOPROSTOL (AS 1% IN HPMC DISPERSION) IN BULK AND TABLET DOSAGE FORM
                  Soni Nirav H., Jain Suresh M., Soni Pooja P.

ABSTRACT
A simple, precise, accurate, and rapid RP-HPLC method has been developed and validated for the determination of Misoprostol as 1% in HPMC{hydroxyl propyl methyl cellulose} dispersion in bulk and Pharmaceutical solid dosage form. The Peak for Misoprostol was resolved using Symmetry C8 Column (150x4.6mm, 5µm) Column and Mobile phase comprising of Acetonitrile, water and orthophosphoric acid (65:35:0.5) at flow rate 1.5 ml/min, the detection of Misoprostol was carried out on absorbance detector at 200nm. A Linear response of 0.999 for Misoprostol in range of 10-30 µg/ml was observed. Solution stability for standard solution and sample solutions was checked out up to 8 hours. Specificity studies showed absence of any interference at analyte peak. Accuracy studies carried out on placebo spiked with API at target concentration gives results within limits. Results were validated statistically and by recovery studies. The proposed method can be successfully used to determine the drug content of marketed formulation.

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How to Cite This Article

Soni Nirav H., Jain Suresh M., Soni Pooja P.,  " VALIDATED RP-HPLC METHOD FOR THE ESTIMATION OF MISOPROSTOL (AS 1% IN HPMC DISPERSION) IN BULK AND TABLET DOSAGE FORM ",  Inventi Rapid: Pharm Analysis & Quality Assurance ,  Vol. 2011 , Article ID- " Inventi:paqa/169/11 " 2011  [ cited 2014 Apr 20 ]  Available From  


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