Quality by design‐based development and validation of an HPLC method for simultaneous estimation of pregabalin and piperine in dual drug‐loaded liposomes

Abstract

The current research work describes the development of a rapid HPLC method for the concurrent detection of pregabalin and piperine in dual drug‐loaded nanoformulations. The primary goal was to recognize the chromatographic conditions wherein propitious segregation of the integrants with quality peaks can be attained. An attempt to expound the target analytical profile was made to accomplish this goal, and critical method attributes (CMAs), viz. percentage acetonitrile content, injection volume and pH, which affect critical quality attributes (CQAs), were identified using systemic risk analysis. Box–Behnken design was employed to develop a relationship between CMAs and CQAs, which engenders an analytical design space. Efficient chromatographic separation for pregabalin and piperine was attained using an analytical C18 column and mobile phase comprising acetonitrile–water (pH 6.9; 70:30%, v/v) in an isocratic elution mode with a 1 ml/min flow rate. The elution was descried at an isosbestic wavelength of 221 nm using a photodiode array detector. The International Conference on Harmonization guidelines were adopted for the developed HPLC method. The validated HPLC method can be further utilized for the simultaneous quantification and detection of pregabalin and piperine in other lipid‐based nanopharmaceuticals such as polymeric nanoparticles, nanocrystals, solid‐lipid nanoparticles, metallic nanoparticles, etc., in in vitro and in vivo studies.

Nanotransethosomes for enhanced transdermal delivery of mangiferin against rheumatoid arthritis: formulation, characterization, invivo pharmacokinetic and pharmacodynamic evaluation

“…Mangiferin (MNF) is a natural xanthanoid chiefly present in Mangifera indica, Iris unguicularis, Salacia chinensis, Cyclopia genistoides, Anemarrhena asphodeloides , and Bombax ceiba (Khare et al., 2016 ; Tang et al., 2014 ). MNF has been copiously used in myriads of therapeutic fields because of its profuse pharmacological profile including antidiabetic, antibacterial, antiarthritic, antitumor, antiviral, anti-inflammatory, antitumor, immunomodulatory, lipometabolism regulating, hepatoprotective, cardioprotective, anti hyperuricemic, antiaging, antioxidative, neuroprotective, antipyretic, and analgesic activity MNF evince promising antiarthritic potential by virtue of its anti-oxidant, anti-inflammatory and analgesic property (Adin et al., 2022a , 2022b , 2022c, 2022d; Adin et al, 2023 ; Gupta et al., 2022a , 2022b , 2022c , 2022d, 2022e ). Luczkiewicz et.…”

Application of QbD based approach in development and validation of RP‐HPLC method for simultaneous estimation of methotrexate and baicalin in dual‐drug‐loaded liposomes

“…After preliminary screening trials and risk analysis were performed, a wide range for method variables were selected. For optimization of method variables, design of experiments (DOE) method was utilized for the optimization of method variables, in which three‐level‐three‐factor Box–Behnken design (BBD) was employed to obtain 17 experimental runs comprising 12 experimental runs and 5 central point replicates; central point replicates help in the validation of method reproducibility and augment the validity of experimental design (Gupta et al, 2022b). For HPLC method development, percentage of acetonitrile, pH and percentage of orthophosphoric acid in the aqueous phase were chosen as the main independent variables, and tailing factor was chosen as the response variable (Table 1).…”

Spanlastics as a Potential Approach for Enhancing the Nose-To-Brain Delivery of Piperine: In Vitro Prospect and In Vivo Therapeutic Efficacy for the Management of Epilepsy

“…Piperine (PIP) is an alkaloid that is chiefly present in plants: Piper nigrum , Piper longum , and Piper officinarum [ 9 ]. PIP has been copiously explored in diverse therapeutic fields due to its multifaceted biological profile that includes antihypertensive, antioxidant, antipyretic, antitumor, anti-asthmatics, analgesic, anti-inflammatory, antidiarrheal, anxiolytic, hepato-protective, antibacterial, antispasmodic, immunomodulatory, antifungal, neuroprotective, antimutagenic, and antimetastatic activity [ 10 , 11 , 12 , 13 , 14 , 15 , 16 ]. PIP manifests promising antiepileptic potential by dint of its antioxidant and neuroprotective potential [ 17 ].…”