Stability indicating HPLC method development and validation for the determination of organic impurities of cariprazine hydrochloride, their characterization by LC-MS and NMR techniques.

Rajesh Kumar, Shailendra Kumar Dubey, Har Lal Singh, Amlan Kumar Das, Sarita Khaturia, Pankaj Kumar

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Article in BMC chemistry, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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6 authors.

Rajesh KumarDepartment of Chemistry, Mody University of Science and Technology, Lakshmangarh, Sikar, Rajasthan, 332311, India.

Shailendra Kumar DubeyAmoli Organics (A division of Umedica Laboratory Pvt. Ltd.), Luna, Taluka-Padra, Vadodara, Gujarat, 391440, India.

Har Lal SinghDepartment of Chemistry, Mody University of Science and Technology, Lakshmangarh, Sikar, Rajasthan, 332311, India.

Amlan Kumar DasDepartment of Chemistry, Mody University of Science and Technology, Lakshmangarh, Sikar, Rajasthan, 332311, India.

Sarita KhaturiaDepartment of Chemistry, Mody University of Science and Technology, Lakshmangarh, Sikar, Rajasthan, 332311, India. saritakhaturia.slas@modyuniversity.ac.in.

Pankaj KumarDepartment of Earth and Environmental Science, Parul Institute of Applied Sciences, Parul University, Vadodara, Gujarat, 391760, India. pankaj.kumar25135@paruluniversity.ac.in.

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6 · The paper itself

Abstract

Cariprazine hydrochloride is an antipsychotic drug used to treat diseases such as schizophrenia and acute mania in adults. Quality determination of the cariprazine drug molecule is a critical aspect to ensure maximum drug efficacy and to minimize side effects caused by unwanted substances commonly referred to as impurities, formed during manufacturing. Hence, this study aims to develop a chromatographic method for the determination of organic impurities present in cariprazine hydrochloride. A stability-indicating and robust method was developed using reverse-phase high-performance liquid chromatography (HPLC). The analytical method involves the simple preparation of a mobile phase consisting of 0.2% orthophosphoric acid in HPLC grade water as mobile phase A, and acetonitrile as mobile phase B. Separation was achieved using a YMC Pack Pro C18 column (150 mm × 4.6 mm, 3 μm), with a step gradient at a flow rate of 1.0 mL/min and detection at λ

Indexed as

Forced degradationHigh-performance liquid chromatographyOrganic impuritiesQuality determinationReverse-phaseStability indicating

Identifiers

PMID42157195

DOI10.1186/s13065-026-01838-6

PMCPMC13366756

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