Saturday , 25 May 2024

RP-HPLC method development and validation for estimation of voriconazole, azithromycin and metoprolol tartrate in pharmaceutical dosage form

K. Dileep*1, Dr. A. Dinakar Reddy2
1Department of Pharmaceutical Analysis, Sun Institute of Pharmaceutical Education and Research, Kakupalli, Nellore, Andhra Pradesh, India.

2Professor & Principal, Sun Institute of Pharmaceutical Education and Research, Kakupalli, Nellore, Andhra Pradesh, India.

A  b  s  t  r a c t
Analytical methods capable of analyzing huge number of samples in a short time period with good robustness, accuracy and precision without any prior separation step. HPLC method generates large amount of quality data, which serve as highly powerful and convenient analytical tool. Voriconazole & Azithromycin was freely soluble in water and alcohol. Metoprolol Tartrate was freely soluble in alcohol and sparingly soluble in water. Methanol and potassium dihydrogen ortho phosphate (pH 3) was chosen as the mobile phase. The run time of the HPLC procedure was 10 minutes. The method was validated for system suitability, linearity, precision, accuracy, specificity, ruggedness robustness, LOD and LOQ. The system suitability parameters were within limit, hence it was concluded that the system was suitable to perform the assay. The method shows linearity between the concentration range of 10-100 µg / ml. The % recovery of Voriconazole, Azithromycin and Metoprolol Tartrate were found to be in the range of 99.22 % – 100.11 %. As there was no interference due to excipients and mobile phase, the method was found to be specific. The method was robust and rugged as observed from insignificant variation in the results of analysis by changes in Flow rate and Mobile phase composition separately and analysis being performed by different analysts. Good agreement was seen in the assay results of Pharmaceutical formulation by developed method. Hence it can be concluded that the proposed method was a good approach for obtaining reliable results and found to be suitable for the routine analysis of Voriconazole, Azithromycin and Metoprolol Tartrate in Bulk drug and Pharmaceutical formulation.

Keywords: Voriconazole, Azithromycin and Metoprolol Tartrate, HPLC.

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