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Abstract

VALIDATED DIFFERENCE ABSORBANCE SPECTROPHOTOMETRIC METHOD FOR ESTIMATION OF TINIDAZOLE IN BULK AND DOSAGE FORMS.

Malathi Raghunath*, Amol Dhamne, Swapnali Borude and Anoop Singh

ABSTRACT

The aim of the present study was to develop a simple, accurate,
precise, reproducible and economical difference UV
spectrophotometric method for quantitative estimation of Tinidazole
(TNZ) in bulk and its formulation. The solvent used for analysis was
0.1N HCl and 0.1N NaOH to induce spectral changes in TNZ so as to
eliminate unwanted absorption arising from pH insensitive substances
in formulations of TNZ. The absorbance was recorded at λmax (276
nm) of TNZ in 0.1N HCl and λmax (366nm) of TNZ in 0.1N NaOH.
The method was validated for parameters such as linearity, accuracy,
precision and limit of quantification, limit of detection, ruggedness and
robustness as per ICH guidelines. The proposed method is thus
recommended for routine analysis of TNZ in bulk and tablet
formulations without any interference of excipients. The use of 0.1N
HCl and 0.1N NaOH was found to be quite satisfactory for the estimation of TNZ and
therefore does not require higher concentrations of HCl and NaOH for sample preparation as
reported earlier.

Keywords: Tinidazole, Validation, ICH guidelines, Difference absorbance spectrophotometric method.


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