World Journal of
Pharmaceutical and Life Sciences

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR DETERMINATION OF LEUPROLIDE IN BULK DRUG AND PHARMACEUTICAL DOSAGE FORM

Bhagyashri G. Pawar, Aejaz Ahmed*, G. J. Khan and Patel M. Siddik

ABSTRACT

Leuprolide (LPL) was quantified using a DAD detector using a sensitive, accurate, quick, variable, resilient, and economical UV Spectrophotometric and HPLC technique. Using methanol like a solvent, UV spectrophotometric measurement was performed at absorption maxima (max) at 278 nm. In this procedure, LPL was separated using a RP- Agilent C18 (length250mm x 4.6ID, 5 micron) column with something like a mobile phase containing methanol: 0.05 percent OPA (60:40; v/v) with a flow rate of 1 ml/min. 20 L of fluid were injected. LPL's retention time was determined to be 5.56 minutes. The system suitability tests and all essential validation parameters were meticulously completed. Over a large concentration range (5–25 g/ml), the analytic curves was linear (r2 = 1 and 0.999). With a relative standard deviation under 2.0%, the system exhibits sufficient accuracy. With a percent RSD under 2 percent, the approach demonstrated good duplicability and recovery. As a result, the suggested approach was determined to be straightforward, narrowly focused, accurate, linear, and robust. As a result, it may be used to analyse Leuprolide (LPL) in bulk medications.

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