Thursday , 30 June 2022

Development and Validation of a HPLC Method for Nelfinavir and Tenofovir in Pharmaceutical Dosage Forms

Undela Jyothi*1, V. Haribaskar2
1PG Research Scholar, Department of Pharmaceutical Analysis, Ratnam Institute of Pharmacy, Nellore.
2Professor, Department of Pharmaceutical Chemistry, Ratnam Institute of Pharmacy, Nellore, A.P.

A  B  S  T  R A C T
The proposed HPLC method was found to be simple, specific, precise, accurate, rapid and economical for simultaneous estimation of Nelfinavir  Acetaminopheneand Tenofovir in tablet dosage form. The developed method was validated in terms of accuracy, precision, linearity, robustness and ruggedness, and results will be validated statistically according to ICH guidelines. The Sample recoveries in all formulations were in good agreement with their respective label claims. From literature review and solubility analysis initial chromatographic conditions Mobile phase ACN: ortho Phosphate buffer pH 4.0 (70: 30 % v/v) were set (Buffer PH 2.45 adjusted with Triethylamine), Agilent C18 column (4.6×150mm) 5µ Column, Flow rate 1.0 ml/min and temperature was ambient, eluent was scanned with PDA detector in system and it showed maximum absorbance at 230 nm. As the methanol content was increased Nelfinavir and Tenofovir got eluted with good peak symmetric properties. The retention times for Nelfinavir and Tenofovir was found to be 2.462 & 3.737 min respectively. System suitability parameters were studied by injecting the standard five times and results were well under the acceptance criteria. Linearity study was carried out between 50% to150 % levels, R2 value was found to be as 0.999 by using above method assay of marketed formulation was carried out, 100.7% was present. Full length method was not performed; if it is done this method can be used for routine analysis of Nelfinavir and Tenofovir.

Keywords: HPLC, Nelfinavir, Tenofovir, Ortho Phosphoric Acid Buffer: ACN, Agilent C18.

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