Abstract

DEVELOPMENT AND VALIDATION OF UV SPECTROPHOTOMETRIC METHOD FOR DETERMINATION OF FLUCONAZOLE IN BULK AND TABLET DOSAGE FORM

Krishnamurthy A. Kamalapurkar, Fariyal N. Shaikh*, Rupali C. Khairate and Akshada R. Shendge

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Abstract

A new simple, accurate, rapid and cost-effective UV spectrophotometric method was developed and validated for the assessment of fluconazole in bulk and tablet dosage form. The Fluconazole showed the maximum absorption at 260 nm in uv range (200-400 nm). The developed method was proved linear in the range of 20-100µg/ml and displayed good regression coefficient (R2 ꞊ 0.997). The % RSD value is < 2, which indicates that the process is precise. The % RSD for inter-day precision and intra-day precision was 1.883 and 0.345 respectively. The % recovery was found to be in the range lies between 98.12 – 102 %. The LOD and LOQ found to be 6.5637 µg/ml and 19.89012 µg/ml respectively. The proposed method was validated for linearity, accuracy, precision, sensitivity and robustness as per ICH guidelines. The results obtained shows that the developed method can be utilized for routine analysis of Fluconazole in bulk and tablet dosage form.

Keywords: Fluconazole, Methanol: Water, UV method, Validation.