Abstract

DEVELOPMENT AND VALIDATION OF ANTINEOPLASTIC DRUG BY HPLC METHOD IN SOLID DOSAGE FORM

Pavankumar Gangavarapu*

ABSTRACT

The study of drugs includes the detection, characterization, and determination of medicines in variations such as drug types and biological fluids. There is an alarming rise in the number of drugs known on the market. The drugs can be new or partial systemic improvements to current drugs. There can be new businesses in the industry. For certain pharmaceuticals or drug combinations, new analytical techniques are created for the following reasons: drug or drug combinations in any pharmacopeia may not be official. An analysis tool for the drug or its formulations could not be found in exploring the literature. Due to interference caused by excipients, analytical approaches may not be usable in the mix. Analytical techniques may not be available or accessible for quantifying the medication or drug mixture in a biological fluid. Analytical approaches for treatment will not be available in conjunction with other medications. For quantification of a brand-new antineoplastic drug during the production phase, an easy and easy HPLC system has been developed and accepted. For precision, repeatability, reproducibility, and temperature- and pH-related resistance of the buffer, the method developed was validated. Both linearity and the detection and quantification limits have been defined. This HPLC technique was considered accurate, precise, and reproducible and can easily be used in the manufacture of the antineoplastic drug in solid form for in-line process control.

Keywords: HPLC, Antineoplastic, Cyclophosphamide, P450.