Quality by Design‐Based Method for Simultaneous Determination of Glimepiride and Lovastatin in Self‐Nano Emulsifying Drug Delivery System
Priyanka Paul, Raj Kamal, Thakur Gurjeet Singh, Ankit Awasthi, Rohit Bhatia
Abstract
ABSTRACT The aim of the present study was to develop a simple, robust, precise, and cost‐effective quality‐by‐design‐based method for the simultaneous estimation of Glimepiride and Lovastatin in a self‐nano emulsifying drug delivery system. The method was developed via a C18 column having dimensions 250 mm × 4.6 mm with a 5 µm particle size. The optimized mobile phase obtained from the central composite design was Methanol, acetonitrile, and Phosphate buffer with pH 4 in the ratio of 70:20:10% v/v, respectively. The flow rate was kept at 1 mL/min and the wavelength was 230 nm (isosbestic point). Furthermore, at this method, both the drugs i.e., Glimepiride and Lovastatin exhibited retention time at 4.5 and 7.6 min. The method was validated according to International Council for Harmonisation Q2(R2) guidelines and all the results of validation were under the acceptance criterion. In addition to this, the developed optimized method was used to quantify Central composite design‐based optimized formulation for drug loading and in‐vitro drug release. The results of the characterization of optimized formulation via simultaneous estimation showed that drug loading of glimepiride and lovastatin was found to be 87.93 ± 2.53% and 89.37 ± 1.93%. Furthermore, the formulation exhibited 99.84 ± 1.39% (glimepiride) and 100.18 ± 1.94% (lovastatin) drug release within 60 min which was also estimated by using the developed method. In addition, prepared formulations achieved 99.84 ± 1.39% and 100.18 ± 1.94% release for Glimepiride and Lovastatin within 60 min, compared to 30.74 ± 1.48% and 34.68 ± 1.89% for the physical mixture. The cell line results confirmed high cell viability, highlighting the potential of formulation for improving solubility, bioavailability, and safety in combination therapies.