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All Journal Journal of Applied Pharmaceutical Research
Gilhotra, Ritu
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Medicine & Pharmacology

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Novel RP-HPLC method development and validation for precise quantification of prochlorperazine maleate in pharmaceutical dosage forms Shrisunder, Nikhil; Dhakad, Prashant Kumar; Gilhotra, Ritu
Journal of Applied Pharmaceutical Research Vol. 13 No. 1 (2025)
Publisher : Creative Pharma Assent

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.69857/joapr.v13i1.782

Abstract

Background: Prochlorperazine Maleate, a piperazine phenothiazine derivative, exhibits strong antiemetic and antipsychotic properties. However, existing analytical methods for its quantification in pharmaceutical formulations often face limitations regarding sensitivity, specificity, and accuracy. Many conventional techniques involve extensive sample preparation and prolonged analysis times, making them less feasible for high-throughput quality control. This study developed and validated a novel, precise, and highly sensitive reverse-phase high-performance liquid chromatography (RP-HPLC) method for Prochlorperazine Maleate quantification to overcome these challenges. Methodology: An RP-HPLC method was established using an Agilent Zorbax Bonus-RP column (250 × 4.6 mm, 5 µm) with a mobile phase of 0.1% formic acid and acetonitrile (70:30). The detection was performed at 258 nm using a diode array detector. Method validation followed ICH guidelines, assessing linearity, precision, accuracy, robustness, and sensitivity across a 100–150 µg/mL concentration range. Results and Discussion: The method displayed strong linearity (R² = 0.999). The LOD and LOQ were 1.76 µg/mL and 5.35 µg/mL, respectively. High precision (%RSD < 2%) and recovery rates (99–101%) confirmed accuracy. Robustness was established through consistent retention time and peak symmetry. Conclusion: This validated RP-HPLC method is reliable, sensitive, and cost-effective, making it ideal for routine pharmaceutical quality control and future stability studies.
Development of a fast-acting nanosuspension nasal drop using a novel co-processed polymer for migraine relief Shrisunder, Nikhil; Dhakad, Prashant Kumar; Gilhotra, Ritu
Journal of Applied Pharmaceutical Research Vol. 13 No. 3 (2025)
Publisher : Creative Pharma Assent

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.69857/joapr.v13i3.940

Abstract

Background: Effective central nervous system (CNS) drug delivery remains challenging due to the blood-brain barrier. Nasal drug delivery offers a non-invasive alternative, ensuring rapid drug absorption and onset of action. Prochlorperazine Maleate, a drug for migraines, suffers from poor solubility, limiting its therapeutic potential. Methodology: A nanosuspension-based nasal drop was developed and optimized using high-pressure homogenization. A novel co-processed polymer enhances solubility and stability. Key formulation parameters, including particle size, zeta potential, and polymer concentration, were optimized using a central composite design. The optimized nanosuspension was characterized for its physicochemical properties, drug release, and stability. Results and Discussion: The optimized formulation (Batch F9) exhibited a particle size of 78.8 nm and a high drug release rate (93.87% in 8 hours). Stability studies confirmed no significant changes in drug content, pH, or osmolality over a three-month period. The nasal drop provided consistent dosing, with each actuation delivering a precise amount of drug content. In vitro drug release studies demonstrated a sustained release pattern, enabling prolonged migraine relief. Conclusion: The developed nanosuspension nasal drop presents a promising solution for CNS drug delivery, ensuring rapid and sustained therapeutic outcomes. This nanosuspension nasal drop achieved a 5.6-fold enhancement in solubility and demonstrated rapid onset within 10 minutes post-administration. Although promising, the study is limited to in vitro characterization; future research should explore in vivo efficacy and long-term safety.
Co-Authors Dhakad, Prashant Kumar Shrisunder, Nikhil