RP-HPLC method validation for fast extraction and quantification of Levonorgestrel drug from silicone based intrauterine device intended for in-process and finished formulation (original) (raw)
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Asian Journal of Pharmaceutical and Clinical Research, 2020
Object: The main objective of the complete study is to develop a new method and also to validate the developed method for the determination of Assay and Content Uniformity of Levonorgestrel by reverse-phase high performance liquid chromatography (RP-HPLC). Methods: RP-HPLC method was developed for simultaneous estimation of levonorgestrel using Hypersil ODS, 125 mm×4.6 mm×5 μm C8 column with a mixture of water, and acetonitrile solution with a ratio of 50:50 as a mobile phase at a flow rate of 1.3 mL/min with a detection of quantification wavelength of 242 nm. Method was selected after calculating system suitability and validated as per International Conference on Harmonization (ICH) guidelines. Results: The developed analytical method parameters found within the limits as given in ICH and USP Guidelines and the total chromatographic analysis time per sample was 8 min with Levonorgestrel Eluting with retention time of 4.479, 4.479, and 4.467 min, respectively. The validated HPLC met...
Analytica Chimica Acta, 2006
A stability-indicating high-performance thin-layer chromatography (HPTLC) method was developed and validated for simultaneous determination of steroidal hormones levonorgestrel and ethinyloestradiol both in bulk drug and in low-dosage oral contraceptives. Optimization of conditions for the spectrodensitometric procedure was reached by eluting HPTLC silica gel plates in a 10 cm × 10 cm horizontal chamber. The solvent system consisted of hexane–chloroform–methanol (1.0:3.0:0.25, v/v/v). This system was found to give compact, dense and typical peaks for both levonorgestrel (Rf = 0.65 ± 0.03) and ethinyloestradiol (Rf = 0.43 ± 0.02). Densitometric analysis of the drugs was carried out in the reflectance mode at 225 nm by using a computer controlled densitometric scanner. The calibration curves of levonorgestrel and ethinyloestradiol were linear in the range of 200–800 and 40–160 ng per spot, respectively. The method was validated for precision, robustness and recovery. As the proposed method can effectively separate the drugs from their degradation products, it can be employed as a stability-indicating method.
Journal of controlled release : official journal of the Controlled Release Society, 2016
Despite a long history of incorporating steroids into silicone elastomers for drug delivery applications, little is presently known about the propensity for irreversible drug binding in these systems. In this study, the ability of the contraceptive progestin levonorgestrel to bind chemically with hydrosilane groups in addition-cure silicone elastomers has been thoroughly investigated. Cure time, cure temperature, levonorgestrel particle size, initial levonorgestrel loading and silicone elastomer type were demonstrated to be key parameters impacting the extent of levonorgestrel binding, each through their influence on the solubility of levonorgestrel in the silicone elastomer. Understanding and overcoming this levonorgestrel binding phenomenon is critical for the ongoing development of a number of drug delivery products, including a multi-purpose technology vaginal ring device offering simultaneous release of levonorgestrel and dapivirine - a lead candidate antiretroviral microbicide...
METHOD DEVELOPMENT BY LC-MS AND QUANTIFICATION BY HPTLC IN TELMISARTAN MARKETED FORMULATIONS
Lycopene, as a natural source of anti-oxidants, has enamoured attention due to its biological and physicochemical properties. It is completely insoluble in water, so to overcome this limitation, an emulsion based approach was being used so that even this hydrophobic moiety can enjoy the unique property of gels. Lycopene, an anti-oxidative agent, has been used in the treatment of various oxidative diseases. This pigment protects the cells against damage from the free radicals formed when body cells burn oxygen for energy. In order to decrease the oxidative reactions with skin i.e. to treat acne vulgaris, lycopene emulgel was developed. The present work was carried out with the grail of formulating a gellified emulsion of lycopene, an anti-oxidative agent. The distinctive feature of topical drug delivery system is the direct accessibility of the skin as a target organ for diagnosis and treatment. Emulgels have emerged as one of the most prevailing drug delivery systems for the delivery of hydrophobic drugs owing to their dual control release system i.e. gel and emulsion. This work was conducted to develop an emulgel of lycopene using three different gelling agents i.e. Carbopol 934P, HPMC LV-15 and NaCMC. Oleic acid was used as a penetration enhancer. The gellified emulsions were characterized for their physical appearance, rheology, spreadability, drug content and stability. In-vitro release studies were conducted to check the drug release through egg membrane. The formulations were evaluated for their antioxidant activity as well as their acute skin irritation potential. Formulation F1 was found to have fallen within the stipulated criteria of all the evaluation parameters. Hence, it was concluded that formulation F1,containing carbopol 934P (1% w/w), was the optimized formulation. It exhibited the maximum drug release and antioxidant activity, in addition to the least skin irritation potential. KEYWORDS: Telmisartan, Lycopene, Emulgel, Gelling agents, Anti-oxidant, LC-MS, HPTLC study.