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Analytical Study of Some Pharmaceutical Compounds Sally

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Analytical Study of Some Pharmaceutical Compounds Sally Analytical Study of Some Pharmaceutical Compounds Thesis presented by Sally Saad El-Din Mahmoud El-Mosallamy B. Pharm. Sci., 2009, M. Pharm. Sci. 2016 Assistant lecturer at Faculty of Pharmacy, Cairo University Submitted for the fulfillment of the Degree of Doctor of Philosophy in Pharmaceutical Sciences "Analytical Chemistry" Under the Supervision of Prof. Dr. Badr El-Dean Abd El-Haleam El-Zeany Professor of Analytical Chemistry Faculty of Pharmacy, Cairo University Assistant Prof. Dr. Nagiba Yehia Mohamed Hassan Assistant Professor of Analytical Chemistry Faculty of Pharmacy, Cairo University Prof. Dr. Hanan Abd El-Monem Merey Professor of Analytical Chemistry Faculty of Pharmacy, Cairo University Department of Analytical Chemistry Faculty of Pharmacy Cairo University 2019 Abstract This thesis is concerned with the analysis of some pharmaceutical compounds in different mixtures. It comprises three parts, part I is about determination of acefylline piperazine and bromhexine hydrochloride in the presence of their degradation products and dosage form excipients (methyl and propylparabens). While part II is about the simultaneous analysis of a binary mixture of camylofin dihyrochloride and analgin in the presence of their degradation products. In addition to Part III which is concerned with the simultaneous analysis of a binary mixture of calcipotriol monohydrate and betamethasone dipropionate in the presences of dosage form excipients (butylated hydroxytoluene and alpha-tocopherol). Various analytical techniques were used for the simultaneous analysis of these mixtures. The applied techniques include spectrophotometry, chemmometry, thin layer chromatography (TLC), high performance liquid chromatography (HPLC) and electrochemistry. The proposed methods were simple, accurate, and reproducible, which would be feasible, and sensitive for the determination of the studied drugs. The proposed methods were validated according to ICH-guidelines. Key Words: Spectrophotometry; chemmometry, thin layer chromatography; high performance liquid chromatography; electrochemistry; bromhexine hydrochloride, acefylline piperazine, camylofin dihydrochloride; analgin; calcipotriol monohydrate and betamethasone dipropionate. Introduction Drugs are co-formulated in order to improve medication compliance by reducing the pill burden of patients. Also, one of the advantages of combined drugs is the ability to compose combined profiles of pharmacokinetics, effects and adverse effects. Quantitative analysis of pharmaceuticals is necessary throughout the various stages of drug development and manufacture. It is considered advantageous to explore accurate rapid methodologies that are low in cost and do not require hazardous solvents, prolonged sample pretreatment or extraction steps. From this perspective, this thesis is concerned with the quantitative determination of pharmaceutical compounds in their mixtures in the presence of dosage form excipients. These mixtures are acefylline piperazine with bromhexine hydrochloride (for treatment of cough), analgin with camylofin dihydrate (for treatment of spasm pain) and calcipotriol monohydrate with betamethasone dipropionate (for treatment of psoraiasis) The first studied mixture is acefylline piperazine with bromhexine hydrochloride. Acefylline piperazine (AC) is a stimulant drug of the xanthine chemical class. It acts as an adenosine receptor antagonist. Xanthines are drugs with complex actions that include, in varying degrees, relaxation of bronchial smooth muscle and relief of bronchospasm, stimulant effects on respiration, and anti-inflammatory effects. Theophylline and its derivatives have long been used for their bronchodilator properties in the management of asthma and chronic obstructive pulmonary disease. Bromhexine hydrochloride (BR) is a mucolytic used in the treatment of respiratory disorders associated with productive cough that associated with viscid or excessive mucus. In addition, BR has antioxidant properties. BR is intended to support the body's mechanisms for clearing mucus from the respiratory tract. In case of productive cough; cough suppressants are inappropriate, since the cough serves the purpose of clearing the airways. Expectorants have been used on the grounds that increasing the volume of secretions in the respiratory tract facilitates removal by ciliary action and coughing Commonly used expectorants are ammonium salts. Mucolytics have been shown to affect sputum viscosity and structure and patients have reported alleviation of their symptoms, but no consistent improvement in lung function has been found. One of the commonly used mucolytics is bromhexine, 1 Hydrating agents liquefy mucus and also have a demulcent effect. Hydration may be achieved simply by inhaled warm moist air. Cough may sometimes be associated with bronchospasm in patients with asthma. Bronchodilators such as beta 2 agonist or antimuscarinic alleviate cough associated with bronchospasm. However, they are not generally considered of benefit in other forms of cough, and hence are not recommended other than in asthma or selected patients with chronic obstructive pulmonary disease Cough and cold preparations containing various combinations of cough suppressants and/or expectorants, with sympathomimetics, antihistamines, or analgesics are available. Some combinations, such as a cough suppressant and an expectorant, seem illogical and have little evidence to support their efficacy. As with many combinations, doses of individual drugs may be inadequate or inappropriate, and the large number of ingredients may expose the patient to unnecessary adverse effects. The second studied mixture is camylofin dihydrochloride and analgin. Analgin (ANA) is a popular analgetic, non-opioid drug, commonly used in human and veterinary medicine. In some cases, this agent is still incorrectly classified as a non-steroidal anti-inflammatory drug (NSAID). ANA is a pro-drug, which spontaneously breaks down after oral administration to structurally related pyrazolone compounds. Apart from its analgesic effect, the medication is an antipyretic and spasmolytic agent. The mechanism responsible for the analgesic effect is a complex one, and most probably rests on the inhibition of a central cyclooxygenase-3 and activation of the opioidergic system and cannabinoid system. ANA can block both PG-dependent and PG-independent pathways of fever induced by lipopolysaccharides (LPS), which suggests that this drug has a profile of antipyretic action distinctly different from that of NSAIDs. The mechanism responsible for the spasmolytic effect of ANA is associated with the inhibited release of intracellular Ca2+ as a result of the reduced synthesis of inositol phosphate. ANA is predominantly applied in the therapy of pain of different etiology, of spastic conditions, especially affecting the digestive tract, and of fever refractory to other treatments. Camylofin (CAM) is a smooth muscle relaxant with both anticholinergic action as well as direct smooth muscle action. Anticholinergic action is produced by inhibiting the binding of acetylcholine to muscarinic receptors, but the action is less pronounced. Direct smooth muscle relaxation is achieved by inhibiting phosphodiesterase type IV, which leads to increased cyclic AMP and eventually reduced cytosolic calcium. Thus camylofin has a 2 comprehensive action to relieve smooth muscle spasm. It is used to treat stomach ache in infants and children. The third mixture is calcipotriol monohydrate and betamethasone dipropionate. Calcipotriol monohydrate (CPM) is an analogue of vitamin D used in the treatment of psoriasis because they appear to induce differentiation and suppress proliferation of keratinocytes. Although vitamin D3 analogues affect epidermal growth, their immunosuppressive properties may be equally important for their antipsoriatic effect. Betamethasone dipropionate (BMD) is a synthetic glucocorticoid with metabolic, immunosuppressive and anti-inflammatory activities given orally, parenterally, by local injection, by inhalation, or applied topically in the management of various disorders in which corticosteroids are indicated. Topical corticosteroids are among the first-line treatments for psoriasis. Combination therapy using corticosteroids with other topical treatments, such as calcipotriol, may be used to reduce adverse effects and improve efficacy of both drugs. Both CPM and BMD are sensitive to oxidizing agents, so the antioxidants BHT and TOCO were co-formulated to preserve CPM and BMD. Therefore the aim of this work is to develop simple, accurate and precise different analytical methods for quantitative determination of CPM and BMD in the presence of TOCO and BHT. Various analytical techniques were used for the simultaneous analysis of these mixtures. The applied techniques include spectrophotometry, chemmometry, thin layer chromatography (TLC) high performance liquid chromatography (HPLC) and electrochemistry. Aim of work To develop different analytical methods that can be used for the determination of the studied drugs in their pure form and in their mixtures. Study the stability of the studied drugs and their routes of degradation and to find methods for their analysis in the presence of their degradation products. To validate the proposed methods according to the ICH guidelines. To statistically compare the results obtained by the proposed methods to those obtained either by the reported or the official methods. To study the applicability of the suggested methods in the analysis
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