title: Dual Wavelength RP-HPLC Method for Simultaneous Determination of Two Antispasmodic Drugs: An Application in Pharmaceutical and Human Serum.
abstract: A reverse phase stability indicating HPLC method for simultaneous determination of two antispasmodic drugs in pharmaceutical parenteral dosage forms (injectable) and in serum has been developed and validated. Mobile phase ingredients consist of Acetonitrile : buffer : sulfuric acid 0.1 M (50 : 50 : 0.3 v/v/v), at flow rate 1.0 mL/min using a Hibar μ Bondapak ODS C18 column monitored at dual wavelength of 266 nm and 205 nm for phloroglucinol and trimethylphloroglucinol, respectively. The drugs were subjected to stress conditions of hydrolysis (oxidation, base, acid, and thermal degradation). Oxidation degraded the molecule drastically while there was not so much significant effect of other stress conditions. The calibration curve was linear with a correlation coefficient of 0.9999 and 0.9992 for PG and TMP, respectively. The drug recoveries fall in the range of 98.56% and 101.24% with 10 pg/mL and 33 pg/mL limit of detection and limit of quantification for both phloroglucinol and trimethylphloroglucinol. The method was validated in accordance with ICH guidelines and was applied successfully to quantify the amount of trimethylphloroglucinol and phloroglucinol in bulk, injectable form and physiological fluid. Forced degradation studies proved the stability indicating abilities of the method.
authors.affiliation: Department of Microbiology, Faculty of Science, University of Karachi, Karachi 75270, Pakistan.
authors.forename: Najmul
authors.initials: N
authors.lastname: Hasan
authors.forename: Mathurot
authors.initials: M
authors.lastname: Chaiharn
authors.forename: Sauleha
authors.initials: S
authors.lastname: Khan
authors.forename: Hira
authors.initials: H
authors.lastname: Khalid
authors.forename: Nawab
authors.initials: N
authors.lastname: Sher
authors.forename: Farhan Ahmed
authors.initials: FA
authors.lastname: Siddiqui
authors.forename: Muhammad Zain
authors.initials: MZ
authors.lastname: Siddiqui