STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF DOXYCYCLINE MONOHYDRATE AND ORNIDAZOLE IN BULK AND PHARMACEUTICAL DOSAGE FORM
AbstractA simple, rapid, precise, cost effective, stability indicating RP-HPLC method has been developed and validated for the simultaneous estimation of Doxycycline monohydrate (DOXM) and Ornidazole (ORN) in Bulk and pharmaceutical dosage form. The chromatographic separation was achieved on Hypersil BDS C18 column (250mm ×4.6mm, 5μm) using a mobile phase consisting of Buffer : Acetonitrile (55:45 v/v) pH 4 adjusted with ortho phosphoric acid at a flow rate of 1ml/min. Detection wavelength was found 260 nm. The retention time found for the drugs DOXM and ORN were 2.8 min and 4.3 min. respectively. The linearity of the method was over the range 12.5 – 75 µg/ml and 62.5– 375 µg/ml for DOXM and ORN, respectively. The validation of method was carried out utilizing ICH guidelines. The described RP-HPLC method was successfully employed for the analysis of pharmaceutical formulations containing combined dosage form. Developed HPLC method can resolve all degradant peaks of both the drugs, so this method is stability indicating in nature
Article Information
53
2228-39
795
2451
English
Ijpsr
A. Srilekha, P. Pavani and B. Sreedhar*
Inorganic and Physical Chemistry Division, Council of Scientific and Industrial Research - Indian Institute of Chemical Technology, Hyderabad 500607, Andhra Pradesh, India
sreedharb@iict.res.in
10 July, 2014
13 November, 2014
18 April, 2015
10.13040/IJPSR.0975-8232.6(5).2228-39
01 May, 2015
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