Determination of nalbuphine hydrochloride, methylparaben, and propylparaben in nalbuphine hydrochloride injection by high performance liquid chromatography

Abstract

SummaryA stability-indicating liquid chromatographic method has been developed for the determination of nalbuphine hydrochloride, methylparaben, and propylparaben in nalbuphine hydrochloride injection. Reversed-phase chromatography was carried out using a mobile phase containing 0.05 % trifluoroacetic acid, acetonitrile, and tetrahydrofuran. Quantitation was achieved with UV detection at 280 rim. Validation data for linearity, accuracy, precision, specificity, and robustness are presented. The chromatographic system resolves nalbuphine from synthetic impurities and degradation products.bisnalbuphine. 10-Ketonalbuphine is another degradation product of nalbuphine that has been found, although at much lower levels. The potential synthetic impurities are [~-nalbuphine and c~-nor-14-hydroxydihydromorphine. Structures of nalbuphine and related compounds are shown in Figure 1. In this method, all synthetic impurities and degradation products are separated from nalbuphine.A survey of the literature revealed that there have been numerous studies concerned with the determination of nalbuphine in biological fluids. Nalhuphine has been determined in plasma using HPLC with either electrochemical detection [3][4][5][6][7] or UV detection [8,9], and in urine by gas chromatography [10][11][12]. Thin layer chromatography has been used to determine nalbuphine in equine urine [13]. However, no methods have been reported for the determination of nalbuphine in commercial preparations. This method was developed for the determination of nalbuphine and parabens in a parenteral product.

Determination of Preservatives in Cosmetics, Cleaning Agents and Pharmaceuticals Using Fast Liquid Chromatography

“…The most frequently used technique in preservative analysis is high-performance liquid chromatography (HPLC) (3,5,(7)(8)(9)(10)(11)(12)(13)(14)(15)(16)(17)(18)(19)(20)(21), with fewer reports on ultrahigh-performance liquid chromatography (UHPLC) (22)(23)(24)(25). A reversed-phase system employing octadecylsilane stationary phases is typically used, with gradient elution by a mixture of water and organic solvents (3, 5-12, 14-19, 21-28).…”

“…Gas chromatography and capillary electrophoresis have been reported much less frequently (27)(28)(29)(30)(31), and single determinations have been made using spectrophotometric (32) or voltammetric methods (33). Spectrophotometric detection is most common in chromatography (5)(6)(7)(8)(9)(10)(11)(12)(13)(14)(15)(16)(17)(18)(19)(21)(22) and some mass spectrometry (3,(23)(24)(25)(27)(28)(29) or chemiluminescent detection (1,20).…”

Pharmaceuticals and Related Drugs

“…Besides these, two books have been published that cover general aspects of the chromatographic analysis of pharmaceuticals ( , ) and reviews have appeared that consider more specific chromatographic topics such as drug purity (), quality control (), and validation (). The popularity of capillary electrophoretic methods continues to expand as do the number articles that deal with either experimental ( − ) or validation ( − ) issues. Other technique-related reviews have been concerned with flow injection analysis (), ion-selective electrodes ( , ), ESI and MALDI mass spectrometry (), scanning probe microscopy (), thermoanalytical methods (), the analysis of antibiotics by LC/MS (), and the characterization of polymorphs and solvates by vibrational spectroscopy and nuclear magnetic resonance spectroscopy ().…”

Separation and determination of clotrimazole, methylparaben and propylparaben in pharmaceutical preparation by micellar electrokinetic chromatography

“…RP-HPLC with UV detection is usually the method of choice for the analysis of MP and PP [15][16][17][18][19][20]. RP-HPLC with electrochemical detection was used for the determination of parabens in ophthalmological solution [21].…”