In all these deliberate Lapatinib FDA varied chromatographic conditions, system suitability parameters meet the acceptance criteria and RSD of the peak areas was found to be <2.0%, the number of theoretical plates per column was >3000 and the USP tailing factor was <2.0 [Table 4]. Table 4 Robustness results of the UPLC method Solution stability The stability of the duloxetine in the swab matrix and standard solution was tested. The spiked sample and standard solution were stored at ambient temperature for 4 days. All the samples were injected into the UPLC system after 1, 2, and 4 days against freshly prepared standard solution. Sample and standard solution were stable up to 4 days. No changes in the chromatography of the stored samples were found, and no additional peak was registered when compared with the chromatograms of the freshly prepared samples.
CONCLUSIONS A new sensitive UPLC method has been developed for the simultaneous determination of duloxetine residues on the pharmaceutical manufacturing surface to control the efficiency of the equipment cleaning. The method was validated in accordance with ICH guidelines and found to be specific, precise, accurate, linear, robust, and rugged. Hence, the method can be used as part of a cleaning validation program in the pharmaceutical manufacture of duloxetine. ACKNOWLEDGMENTS The authors are thankful to the management of Dr. Reddy’s Laboratories Ltd., Hyderabad, for providing facilities to carry out this work. Footnotes Source of Support: Research facility was provided by Dr. Reddy’s Laboratories Ltd., Hyderabad.
Conflict of Interest: None declared.
Terbinafine hydrochloride, (E)-N-(6,6-dimethyl-2-hepten-4-ynyl)-N-methyl-1-naphthalene methanamine hydrochloride [Figure 1], is a new potent antifungal agent of allylamine class that selectively inhibits fungal squalene epoxidase. The drug is indicated for both oral and topical treatment of mycoses.[2,3] Terbinafine hydrochloride is not yet official in any pharmacopeia, where, only few analytical methods have been reported for its determination in pharmaceutical formulations and biological fluids. Such methods include HPLC,[4�C10] colorimetry, electrochemistry, and solvent meting method. Figure 1 Chemical structure of terbinafine hydrochloride Among the various methods available for the determination of drugs, spectrophotometry continues to be very popular, because of their simplicity, specificity, and low cost.
Carfilzomib This study presents a new spectrophotometric method for the determination of terbinafine hydrochloride phosphate in bulk and pharmaceutical formulations. Accordingly, the objective of this study was to develop and validate the UV-spectrophotometric method for the estimation of terbinafine hydrochloride in bulk and pharmaceutical formulations as per ICH guidelines. MATERIALS AND METHODS Materials Terbinafine hydrochloride was a gift sample from Dr. Reddys Lab, Hyderabad.