Development of RP-HPLC based analytical method for determination of cariprazine hydrochloride in bulk drug and pharmaceutical dosage form using box-behnken statistical design

Chiprikar, Pallavi; Mastiholimath, Vinayak

doi:10.1080/22297928.2023.2242857

Analytical Chemistry Letters

2023

DOI: 10.1080/22297928.2023.2242857

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Development of RP-HPLC based analytical method for determination of cariprazine hydrochloride in bulk drug and pharmaceutical dosage form using box-behnken statistical design

Pallavi Chiprikar,

Vinayak Mastiholimath

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2024

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Cited by 3 publications

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Efficient and environmentally friendly spectrofluorimetric determination of cariprazine: An analytical and green chemistry approach

Almalki

2024

Luminescence

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Cariprazine represents a new generation of antipsychotic medication, characterized by its heightened affinity for the D3 receptor. It has recently obtained approval as an adjunctive treatment option for patients diagnosed with major depressive disorder. In this study, a novel approach utilizing fluorescence spectroscopy was developed to analyze cariprazine. The methodology involves the transformation of cariprazine into a fluorescent compound by means of chemical derivatization with 4‐chloro‐7‐nitrobenzo‐2‐oxa‐1,3‐diazole (NBD‐Cl). Following excitation at 470 nm, the fluorescent derivative displayed peak fluorescence emission at 550 nm. The factors influencing the derivatization process were optimized. Upon reaching the optimal reaction conditions, a linear correlation (r2 = 0.9995) was observed between the fluorescence intensity and concentrations of cariprazine ranging from 20 to 400 ng/ml. Detection and quantitation limits were determined to be 5.85 and 17.74 ng/ml, respectively. The approach was accurate and precise, with percent recovery values ranging from 98.14% to 99.91% and relative standard deviations of less than 2%. Application of the method to the analysis of cariprazine in bulk and commercial capsules forms yielded accurate results. Moreover, adherence to environmentally friendly analytical practices was evident through alignment with the principles of green analysis, as demonstrated by the analytical eco‐scale, AGREE, and GAPI greenness assessment tools.

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Efficient and environmentally friendly spectrofluorimetric determination of cariprazine: An analytical and green chemistry approach

Almalki

2024

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A robust ultra performance liquid chromatography method for dacarbazine quantification in nanosponge formulation: A quality by design approach

Vankudre,

Shirkoli,

Shetti

2024

Analytical Chemistry Letters

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Quality by Design Approach for the Development of Cariprazine Hydrochloride Loaded Lipid-Based Formulation for Brain Delivery via Intranasal Route

Chiprikar,

Mastiholimath,

Biradar

et al. 2024

CDM

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Background: Cariprazine (CPZ) is a third-generation antipsychotic medication that has been approved for treating schizophrenia. This study aimed to develop a cariprazine-loaded nanostructured lipid carrier (CPZ-NLCs) to prevent first-pass metabolism and improve bioavailability and site-specific delivery from the nose to the brain. Method: The CPZ-NLCs were prepared using melt emulsification. The formulation was optimized using the Box–Behnken design (BBD); where the influence of independent variables on critical quality attributes, such as particle size and entrapment efficiency, was studied. Result: The optimized batch (F6) had a particle size of 173.3 ± 0.6 nm and an entrapment efficiency of 96.1 ± 0.57%, respectively. The in vitro release showed >96% release of CPZ from NLC within 30 min. The optimized formulation's ex vivo studies revealed significantly increased CPZ permeability (>75%) in sheep nasal mucosa compared to the CPZ suspension (~26%). The ciliotoxicity study of the nasal mucosa revealed that the CPZ-NLC formulation did not affect the nasal epithelium. The intranasal administration of the formulation achieved 76.14±6.23 μg/ml concentration in the brain which was significantly higher than the oral CPZ suspension administration (30.46±7.24 μg/ml). The developed formulation was stable for 3 months. Conclusion: The study concluded that the developed CPZ-NLC could significantly improve the bioavailability with quick delivery to the brain.

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Development of RP-HPLC based analytical method for determination of cariprazine hydrochloride in bulk drug and pharmaceutical dosage form using box-behnken statistical design

Cited by 3 publications

References 18 publications

Efficient and environmentally friendly spectrofluorimetric determination of cariprazine: An analytical and green chemistry approach

Efficient and environmentally friendly spectrofluorimetric determination of cariprazine: An analytical and green chemistry approach

A robust ultra performance liquid chromatography method for dacarbazine quantification in nanosponge formulation: A quality by design approach

Quality by Design Approach for the Development of Cariprazine Hydrochloride Loaded Lipid-Based Formulation for Brain Delivery via Intranasal Route

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