[期刊论文][Research Article]


DEVELOPMENT AND VALIDATION OF RP-UFLC METHOD FOR THE ESTIMATION OF TERBINAFINE HCl IN PHARMACEUTICAL NANOEMULSION GEL

作   者:
V.V.S.NARAYANA REDDY K;SURESH KUMAR R;HEMNATH E;VENKATA SIDDHARTHA T;KARTHIK YAMJALA;RAJKUMAR MALAYANDI;

出版年:2014

页     码:586 - 590
出版社:International Journal of Pharmacy and Pharmaceutical Sciences


摘   要:

Objective: To develop a simple, accurate, sensitive and rapid isocratic reverse phase ultra-force liquid chromatographic (RP-UFLC) method for the quantitative and qualitative estimation of terbinafine HCl in the bulk and nanoemulsion gel formulation. Me thods: The chromatographic separation was achieved on stationary phase Phenomenex C18 column (250mm x 4.6mm, 5μ) by using mobile phase of methanol and 25mM of phosphate buffer (pH 4.0) in 80:20 ratio and detection was carried out at 222nm. Various validation parameters such as specificity, linearity, accuracy, precision, ruggedness and robustness were performed. Results: The developed method provided coefficient correlation equal to 0.997 in the range of 10μg/ml to 500μg/ml indicating good linearity. Recovery studies showed that the results obtained were within the limits indicating the accuracy of the method. The intra-day and inter day variability were represented in percentage relative standard deviation (RSD) which showed a variation of less than 1.7. The presence of polymers and other components did not affect the results indicating the selectivity of the developed method. Conclusion: The developed RP-UFLC method was validated as per ICH guidelines and can be used for the qualitative and quantitative estimation of terbinafine HCl in bulk, nanoemulsion gel formulation as well as other pharmaceutical formulation



关键字:

Terbinafine HCl; RP-UFLC; ICH; Nanoemulsion gel.


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所属期刊
International Journal of Pharmacy and Pharmaceutical Sciences
ISSN:
来自:International Journal of Pharmacy and Pharmaceutical Sciences