Journal of Chemical and Pharmaceutical Research (ISSN : 0975-7384)

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Original Articles: 2017 Vol: 9 Issue: 3

Simultaneous Estimation of Terconazole and Benzoic Acid in Bulk and Creams Using RP-HPLC, Derivative Spectrophotometry and Chemometric Techniques

Abstract

Terconazole (TER) (anti-fungal) is commonly co-formulated with benzoic acid (BZO) (preservative) in pharmaceutical preparations. So, three simple, precise and selective analytical methods were developed and validated for estimation of TER and BZY simultaneously. The first method based on high performance liquid chromatographic (HPLC) separation of TER and BZO using a mixture of water [containg 0.2%, v/v TEA, pH adjusted to 3.5 with orthophosphoric acid]: acetonitrile: (30:70, v/v) as the mobile phase at a flow rate 1 mL min-1 at ambient temperature on an Agilent TC-C18 (2) column (250 mm× 4.6 mm, 5 μm) with UV detection at 250 nm and 225 nm for TER and BZO, respectively. The linearity range was found to be (4-128 μg mL-1) for TER and (4-128 μg mL-1) for BZO. The second method based on first order derivative spectrophotometry. Trough amplitudes (D1) of TER and BZO were measured at 320 nm and 283 nm, respectively using acetonitrile as solvent. The linearity range was found to be (5-40 μg mL-1) for TER and (4-15 μg mL-1) for BZO. The third method based on three multivariate calibration chemometric techniques, namely, classical least squares (CLS), principal component regression (PCR), and partial least-squares (PLS) using mixtures containing the two compounds in acetonitrile. Calibrations were constructed using the absorption data matrix corresponding to the concentration data matrix. The method is valid over concentration range (3-11 μg mL-1) for TER and (1.4-5.6 μg mL-1) for BZO. The three proposed methods were validated according to international conference on harmonization (ICH).