Analytical Method Development and Validation of Ornidazole and Miconazole Nitrate in Bulk and Tablet Dosage Form

Abstract

An HPTLC method has been optimized and validated for the simultaneous estimation of ornidazole and miconazole nitrate in bulk and tablet dosage form. The antibiotic ornidazole breaks down the DNA of bacteria and other infectious microbes, the antifungal drug miconazole nitrate prevents the growth of fungus by preventing them from developing their protective outer layer. Together, they efficiently treat the condition and promote in getting rid of fungal diseases. The mobile phase of nhexane: methanol (8: 2 v/v) was chosen because it provided good resolution and acceptable peak characteristics. The samples were applied using a sample applicator and a 100 μL sample syringe on a precoated silica gel plate 60 F₂₅₄ (10 × 10) with a 250 μm thickness, forming bands of 6 mm width with 8 mm between each band. Using a 20 mm/sec scanning speed and a slit size of 5 mm by 0.45 mm, development took about 15 minutes. At 310 nm, densitometry scanning was carried out on every development that used the WINCATS software. The radiation emitted came from a deuterium lamp. R_f value was found to be 0.27 ±  0.15 for miconazole and 0.74 ± 0.12 for ornidazole. The method fulfilled, every validation specifications described in the ICH Q2 R1 guidelines, and it was determined to be linear for the drugs ornidazole and miconazole nitrate, with correlation coefficients of 0.9987 and 0.9985, respectively. For Miconazole Nitrate, the linearity range was 100–600 ng/band, while for Ornidazole, it was 500–3000 ng/band. The method's percent RSD was determined to be no higher than 2%, making it precise, accurate, and robust. In order to regularly analyse drug samples, the specified method can be implemented