Development and Validation of RP- HPLC Method for Simultaneous Estimation of Saquinavir in Bulk and Dosage Form

Attempts were made to develop RP-HPLC method for simultaneous estimation of Saquinavir from tablet. For the RP HPLC method, Younglin (S.K.) Gradient system UV detector and C18 (Cosmosil) with 150mm x 4.6 mm i. d. and 5ìm particle size Methanol : Water 0.05 % OPA (65:35v/v) pH 3.0 was used as the mobile phase for the method. The detection wavelength was 239 nm and flow rate was 0.7 ml/min. In the developed method, the retention time of Saquinavir were found to be 6.5 min. The developed method was validated according to the ICH guidelines. The linearity, precision, range and robustness was within the limits as specified by the ICH guidelines. A new, simple, accurate, precise, linear and rapid RP-HPLC method was developed and validated for the simultaneous estimation of Saquinavir in bulk drugs and formulations as per ICH guidelines. Hence the method was found to be simple, accurate, precise, economic and reproducible. So, it is worthwhile that, the proposed methods can be successfully utilized for the routine quality control analysis Saquinavir in bulk drug as well as in formulations.