ANALYTICAL METHOD DEVELOPMENT AND VALIDATION BY RP-HPLC FOR THE SIMULTANEOUS ESTIMATION OF ORNIDAZOLE AND OFLOXACIN IN PHARMACEUTICAL DOSAGE FORM
Author(s):
KIRAN J SUTHAR, Megha K Patel, Vishal T Chudasama, Bharat S Rajpurohit, Ashok B Patel
Keywords:
Ofloxacin; Ornidazole, RP-HPLC; Validation.
Abstract
A simple, precise, accurate and precise reverse phase high performance liquid chromatographic method has been developed and validated for the estimation of Ornidazole and Ofloxacin simultaneously in combined dosage forms. A Lichrospher 100 C-18 and mobile phase comprises of 750 volume of Water, 250 volume of Acetonitrile, 3.5 volume of Triethylamine, and the final pH adjusted to 3.25 ± 0.10 with 10% v/v o-phosphoric acid. Measurements were made at the effluent flow rate of 1.0 ml/min with injection volume 20 µl and ultraviolet (UV) detection at 320 nm, as both components show reasonably good response at this wavelength. The retention times of Ornidazole and Ofloxacin were 5.75 min and 3.25 min, respectively. The method was validated in terms of linearity, accuracy, precision, robustness and specificity. Linearity of Ornidazole and Ofloxacin was in the range of 1-70 µg/ml and 1-70 µg/ml, respectively. The limit of detection and limit of quantification were found to be 0.3 and 0.9 mg/ml for Ornidazole and, respectively and for Ofloxacin were 0.5 and 1.52 mg/ml respectively. The method was validated for specificity, linearity, precision, accuracy and robustness. The linear regression analysis data, Limit of Detection values, Limit of Quantitation values and Percentage RSD of Ornidazole and Ofloxacin were found under acceptance criteria. The method is useful in the quality control of bulk manufacturing and pharmaceutical dosage forms.
Article Details
Unique Paper ID: 167008

Publication Volume & Issue: Volume 5, Issue 12

Page(s): 284 - 289
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