Estimation of Tramadol Hydrochloride and Diclofenac Sodium

Estimation of Tramadol Hydrochloride and Diclofenac Sodium Derivative Spectrophotometric Method for Estimation of Tramadol Hydrochloride and Diclofenac Sodium in Pharmaceutical Dosage Form Pekamwar S. S., Kalyankar T. M, Lokhande M. V. ABSTRACT Purpose: Tramadol is opioid analgesic and diclofenac is NSAID and are used in severe to moderate pain management. Combination of Tramadol and Diclofenac drugs were approved by FDA to market in India with a dose of 50 mg for TRA and 75 mg DIC respectively. Method: The employed method is based on first order derivative spectrophotometry. Wavelengths 278.7 nm and 281.7 nm were selected for the estimation of the Tramadol and Diclofenac respectively by taking the first order derivative spectra. The concentrations of both drugs were determined by proposed method. The results of analysis have been validated statistically and by recovery studies as per ICH guidelines. Result: Both the drugs obey Beer’s law in the concentration range of 5-30 ÃŽ ¼g mL-1 and 5-45 ÃŽ ¼g mL-1 with regression 0.9997 and 0.9990, intercept- 0.0008 and 0.0062 and slope- 0.004 and 0.0316 for TRA and DIC respectively. The accuracy and reproducibility results are close to 100% with 2% RSD. Conclusion: A simple, a ccurate, precise, sensitive and economical procedures for simultaneous estimation of Tramadol and Diclofenac in tablet dosage form have been developed Key words: Tramadol, Diclofenac, First order derivative spectrophotometry, ICH guidelines, Validation, FDA Introduction Tramadol Hydrochloride (TRA) is a synthetic 4-phenylpiperidine analogue of codeine. Chemically it is cis -2-[(dimethylamino) methyl]-1-(3 methoxyphenyl) cyclohexanol hydrochloride (Figure-1), is a centrally acting opioid analgesic, indicated in the treatment of moderate to severe pain. TRA is used to treat postoperative (dental, cancer etc.) pain, treatment of rheumatoid arthritis, restless legs syndrome, motor neuron disease and fibromyalgia and as an adjuvant to NSAID therapy 1-8. Chemically Diclofenac Sodium (DIC) is 2-{2-[(2, 6- dichlorophenyl) amino] phenyl} acetic acid (Figure -2), is a nonsteroidal anti-inflammatory (NSAID) drug. DIC gives anti-inflammatory, antipyretic, and analgesic action thought the inhibition of prostaglandin synthesis by inhibition of cyclooxygenase (COX). DIC is used in acute to chronic treatment of signs and symptoms of osteoarthritis and rheumatoid arthritis 9-19. Tramadol (50 mg) and Diclofenac (75 mg) combination, resulting central and peripheral analgesia a â€Å"balanced analgesia† used in wider spectrum of pain management. In the literature survey it was found that various analytical methods involving spectrophotometry 1-4, HPLC (High-performance liquid chromatography) 5-7, stability-indicating RP-HPLC (Reverse phase high performance liquid chromatography) 8, and GC/MS (Gas chromatography- mass spectrophotometry) 7 have been reported for TRA in single form and in combination with other drugs. Several analytical methods have been reported for DIC in single form and in combination with other drugs including spectrophotometry 9-12, HPLC 13-16, RP-HPLC 17,18, and LC-MS (Liquid chromatography-mass spectrophotometry) 19. Extensive literature survey reveals that derivative spectrophotometric method is yet not reported for simultaneous determination of TRA and DIC in tablet dosage form. In the present work an attempt is being made to develop simple, precise, accurate and reproducible first-order derivative UV- spectrophotometric method for simultaneous estimation of TRA and DIC in combined dosage form. Materials and Methods Apparatus and Instruments The instrument used in the present study was UV- spectrophotometer UV-1800 (Shimadzu, Japan) with spectral bandwidth of 2 nm and 10 mm a matched quartz cell was used. All weighing was done on Digital balance (Anamed). Chemicals and Reagents Analytically pure drug sample of TRA and DIC was kindly provided by Supriya Lifescience Ltd. (Mumbai, India) and J.B. Chemicals Pharmaceuticals Ltd. (Gujarat, India) respectively. The pharmaceutical dosage form used in this study was unavailable in market but has been approved by the FDA to market in India. So this bilayer (Core) tablets manufactured in School of Pharmacy, S.R.T.M. University, Nanded, labeled to contain 50 mg of TRA and 75 mg of DIC. All chemicals (AR grade) were purchased from RANKEM, Delhi, India. Preparation of standard stock solutions Accurately weighed 10 mg of TRA and DIC transferred to two separate 100 mL volumetric flasks. Added sufficient methanol and sonicated for 5 min. and volume was made upto 100 mL with methanol. 1 mL of the stock solution was further diluted to 10 mL with methanol to get a working standard solution of concentration 10 ÃŽ ¼g mL-1 of both TRA and DIC and scanned in the wavelength range of 200-400 nm. First-Order Derivative Spectroscopic Method 20, 21 Working standard solution of concentration 10 ÃŽ ¼g mL-1 of both TRA and DIC were scanned in spectrum mode between 400-200 nm using methanol as a blank. Then zero order spectrums of both the drugs were transformed mathematically into their individual first order derivative spectrum and first derivative overlain of both the drugs were obtained in 400-200 nm which is shown in figure 3, figure 4 and figure 5. It was observed that wavelengths selected for quantification of both the drugs were 281.7 nm for TRA and 271.7 nm for DIC in such a way that at zero crossing of one drug another drug shows substantial absorbance (Zero crossing method). Therefore these two wavelengths were employed for the estimation of TRA and DIC without any interference. The calibration curves were plotted at these two wavelengths. Preparation of Sample Stock Solution Contents of twenty tablets were weighed accurately and powdered. Powder equivalent to 50 mg of TRA and 75 mg of DIC was weighed and dissolved in 50 mL of methanol with the aid of ultrasonication for 5 min. The solution was filtered through Whatman filter paper no. 41 to a 100 mL volumetric flask. Filter paper was washed with methanol, adding washings to the volumetric flask and volume was made up to the mark with methanol to get sample stock solution which was further diluted with methanol to get final concentration of solution (TRA 10 ÃŽ ¼g mL-1 and DIC 15 ÃŽ ¼g mL-1 ) in the linearity range. Results and Discussions Linearity and range A standard stock solution was prepared for both TRA and DIC; they were serially diluted to yield six for TRA and nine for DIC standard solutions. For UV spectrophotometric method, linearity was obtained in concentration range of 5-30 ÃŽ ¼g mL-1 and 5-45 ÃŽ ¼g mL-1; with regression 0.9997 and 0.9990, intercept- 0.0008 and 0.0062 and slope 0.004 and 0.0316 for TRA and DIC respectively. The results are depicted in table1. Accuracy and precision To ascertain the accuracy of the proposed methods, recovery studies were carried out by standard addition method at three different levels (80%, 100% and 120%) as per ICH guidelines. Known amount of pure TRA and DIC were added in preanalyzed powder of tablet formulation and analysis was carried out by proposed method for recovery at each level and % recovery, SD, % RSD was calculated. Results of recovery studies are shown in Table 2. The accuracy and reproducibility is evident from the data as results are close to 100 % and the value of standard deviation and % R.S.D. were found to be Specificity The proposed method was found to be specific as there is no interference from other excipients. Results of analysis of tablet formulation Analysis of formulated tablet was carried out and the amounts recovered were expressed as percentage amount of tablet claim. The percentage recovery for TRA is 100.52 ±1.486 and DIC is 99.57 ±0.555 respectively. The proposed methods was evaluated by the assay (n = 6) of formulated tablets containing TRA and DIC. The results of assay are presented in Table 3. LOD and LOQ LOD was found to be 0.0686  µg mL-1and 0.155  µg mL-1 for TRA and DIC respectively. LOQ was found to be 0.2081  µg mL-1 and 0.4719  µg mL-1 for TRA and DIC respectively. The results of LOD and LOQ are shown in table 4. Conclusion The first-order derivative spectrophotometric method has been developed for simultaneous determination of TRA and DIC in combined dosage form. The developed and validated first order derivative spectrophotometric method is simple, economic, accurate and reproducible. The method was validated as per ICH guidelines in terms of linearity, specificity, accuracy, precision, limits of detection (LOD) and limits of quantification (LOQ). The proposed validated method can be utilized for routine analysis and quality control assay of TRA and DIC in combined dosage form. Acknowledgments The authors are very thankful to Supriya Lifescience Ltd., Mumbai and J.B. Chemicals Pharmaceuticals Ltd., Gujarat, India for providing Tramadol Hydrochloride and Diclofenac sodium respectively as gift samples of pure drugs. Authors are also very thankful to School of Pharmacy, Swami Ramanand Teerth Marathwada University, Nanded, Maharashtra, India for providing all the necessary facilities to complete research work very successfully. Conflict of interest The authors report no conflicts of interest.

Of Mice and Men “Which of the character in of mice and men is the loneliest and why?” Essay

â€Å"Of mice and men† is the title of John Steinbeck’s novella the name is inspired by Robert Burns’s poem. There was a belief that America was the land of opportunity. In the nineteen hundreds, there was great depression in America because there wasn’t enough money around, so people couldn’t get jobs with decent pay. Some people went around from farm to farm doing temporary work, they were called ranch workers. Due to this lack of money and jobs being temporary, people moved around so much they were unable to hold friendships, so some people became very anti social and others developed unusual characteristics. John Steinbeck was a writer who did travel around ranches and had an idea of what the ranch life was like I believe he wrote the novella not just to show people the lives lead in the great depression but also to give them an idea of what his personal experiences had been like. The two main characters in â€Å"Of Mice and Men† are George and Lennie. George is first introduced as being â€Å"small and quick, dark of face, with restless eyes and sharp, strong features.† where as Lennie is described as being Georges opposite â€Å"his opposite, a huge man, shapeless of face, with large, pale eyes, with wide sloping shoulders:† Lennie is very distinctive for his animal like qualities. During the play Of Mice and Men George and Lennie go round together unlike most others people in there time. Lennie has a mental disability where he forgets large amounts of the information he is given. This causes him to have to rely on his instincts. He possesses a child-like characteristic in the way he acts and responds to the feedback others give him. Lennie is a large, powerful man. He and George have a strong friendship and have known each other for a long time and don’t want to lose each other despite the friction that Lennie’s memory occasionally causes in conversations. George is a clever person and has a powerful friendship with Lennie. He finds that he is sometimes isolated from proper conversation when alone with Lennie because of his superior intellect and understanding. George has a need to look after Lennie like a parent due to Lennies mentality, he was asked by Lennies aunt to look after him when she died. I believe he uses this reason as a partial excuse to hide his attachment to Lennie as a friend and parental figure which he needs to feel moderately more secure than those around him who travel alone. Both Lennie and George need each other’s friendship and each other’s ability to survive; George provides Lennie with knowledge of what to do and how to survive whereas George has Lennie to protect him from physical attacks as they go around. They also share a hope to accomplish the â€Å"American dream† to go â€Å"‘An’ live of the fatta the lan'† as Lennie states which basically means is to live of the land or farm the crops. I feel that both characters have developed unusual characteristics to deal with the lack of people they can rely on and trust. Lennie has an unusual desire to pet anything that’s alive and show it affection. This attachment to his desire causes him to break the rules George sets him to help himself. I think this form of emotion is propelled by his desire to have happiness and be loved by something that lives. This is fairly ironic as every animal he pets he kills due to his strength, which in turn creates a void of loneliness in Lennies life. George does not appear to have any huge flaws, he is fairly untrusting as to why people do things and analyses everything he’s told. Apart from Lennie, he has no solace and even the trust between him and Lennie cannot give him too much support as Lennie is retarded and attempts to sneak animals around with him. Because they both have each other, they don’t feel like the loneliest people in the world. Is something George says to Lennie â€Å"Guys like us, that work on ranches, are the loneliest guys in the world† â€Å"With us it ain’t like that. We got a future. We got somebody to talk to that gives a damn about us.† Is what Lennie says after George has done his part of there story so all in all I don’t believe that either George or Lennie are the loneliest characters in Of Mice and Men because they have a friendship that no one else has and can talk between each other to an extent without worrying over consequences. The next person to be properly introduced into the novella is Candy, an old man who enters slowly into the room. Candy walks in and has his dog next to his heel an old sheep dog â€Å"gray of muzzle, and with pale, blind old eyes. The dog struggled lamely to the side of the room and lay down, grunting softly to himself and licking his grizzled, moth-eaten coat.† The dog is old and tired and hurts as it moves around; later on the dog is shot as it is of no use to anyone and is in pain whilst it’s alive. I feel the sheep dog reflects its owner’s future; as Candy grows older, he will be no use to any farm and will be kicked out and die due to his lack of money. I personally feel that the dog’s qualities are mentioned more than the man’s so that you see the man like his dog sharing a sort of bond similar to George and Lennies. Candy loses his dog the chapter after it is introduced. This dog is an animal that Candy has become extremely attached to and I believe he sees it as an old companion he can always trust to be there. When he looses his dog he looses his friend. Candy knows he is getting old and his fate in the novella seems sealed and he knows it. When he is of no use and cant do any labor work he will die. Which shows he must have lead a fairly lonely unfulfilled life even by that years standards. I consider Candy to be one of the people who could possibly be seen as the loneliest as he loses his companion and is sort of an image of how most ranch workers are doomed to end up dying due to loosing there abilities to work. He shows how desperate he is to escape his fate when joining with George and Lennie to try and get enough money to buy some land. The next character to be mentioned in â€Å"Of mice and Men† is Crooks he is a black person who is referred to as a nigger. He is disabled and outcast from the society of white people as racism was very strong in those years. He lives in a stable away from everyone else in the novella and has only books for company. The only one who ever enters his room without a purpose is Lennie and when he does Crooks starts off being uneasy about it when more people enter he pretends to be angry but it says â€Å"It was difficult for Crooks to conceal his pleasure with anger.† I think this suggests he is a decent guy who likes company but doesn’t want to appear weak to any of them. Crooks is taken advantage of by Curley’s wife a character who appears to everyone in the play to be trouble and not worth any of there time. She discriminates Crooks and has power over him because she is the bosses’ sons’ wife and they will believe anything she says about him and if that happens he will get kicked off the ranch. Of all of the people to be alone in this novella I believe Crooks is possibly one of the loneliest. Crooks has no one to be friends with, is discriminated against and shown prejudice and is also disabled so he cannot walk or get around easily. I think Crooks represents all people treated poorly because of racism and in a way how black people lived through the depression. The next person to enter into the novella is a woman whose name is never shown as she is always referred to as Curley’s wife, which shows that males are the dominant sex at the time the play is based on. Curley’s wife is the only woman within the entire novella she is a very complex woman and shows different people varied personality. She comes into the story flirting with the group of men she meets to tempt the men for attention and because she is bored. She wears makeup and has red lips and polished nails this suggests she has a lot of spare time. She is considered bad news by the men who are around her because she is the wife of Curley who is the son of the boss and can get anyone kicked off the farm. When alone with Lennie Curley’s wife confide in him about her life â€Å"I don’t like Curley. He ain’t a nice fella.†, â€Å"Coulda been in the movies, an’ had nice clothes – all of them nice clothes like they wear† I think that Curley’s wife was tricked by a chat up line about the possibility of her being in the movies and is fairly naive about the fact he could have been lying. I believe that she thought she was running out of options and time and decided to be with someone who wasn’t doing to badly for themselves and went with Curley. I believe this was a bad idea because Curley doesn’t have any time to be with her except to make she is being loyal to him and whilst doing this makes everyone try to evade her so they don’t get into trouble with Curley. So Curley’s wife doesn’t receive much attention apart from when taunting the men. She knows she has power over one of the workers especially and threatens Crooks as she knows how easily she can get him into trouble so she uses this power to entertain herself and discriminates him. I think that Curley’s wife could be one of the loneliest in the novella as everyone deliberately tries to evade her. Anyone she stays around gets threatened by her husband that does not spend time with her so she is left alone and since there are no other women around on this farm she is alone and powerless. Curley enters the novella shortly after his wife has and demands someone tell him where she is. I think Curley is a very insecure and aggressive, ignorant person. He is insecure because he is short and uses his strength to fight people who are tall so as to show that he is strong and keep a powerful reputation this makes him aggressive so the people he works around don’t like him. I feel he is ignorant for various reasons he fights to prove he is strong but the only one he is proving this too is himself whilst doing this he scares everyone else away as whoever he does fight will get in trouble and risk loosing there job as he is the son of the boss. Curley I don’t think is one of the loneliest in the novella as he has a wife and a successful parent to look after him and keep him content in several ways, he has the power to get rid of people he does not like or work against them and he gets respect from his status. Of all of these main characters in the novella I consider Candy and Crooks to be the two loneliest Candy because of the fact he knows how he will soon be useless and the fact he looses his closest companion and Crooks because he is disabled and discriminated against yet seems happy to be around people. I think Crooks also because he is sort of an outcast from a community that is made up from people who are afraid of each other but still able to group up on him when he is around. Both of these characters know they have no future where they are and wont be able to secure anything before dying both there fates are sealed with them completely alone unlike all the others that’s why I chose them.

A Day in the Life of a Mental Health Counselor Essay

It is a privilege to interview veteran therapists who are exiting the counseling arena after a long career in the profession. I was honored to shadow Lea Keylon, a seasoned counselor, who on the eve of retirement set aside time for a student interview. The enlightening interview opened my understanding to the importance of proper diagnostic coding for insurance reimbursements, the financial struggles of private practice, and the poignant effect of forensic counseling on therapist (L. Keylon, personal communication, March 26, 2010). Lea was eager to share her counseling accounts; however, the excitement of retirement planning could be seen in her demeanor. Private practice requires self-discipline, constant research for legislative†¦show more content†¦Keylon, personal communication, March 26, 2010). Private Practice Contentment and Distress Lea, very graciously, invited me into a very small office space. Stating that her walls are not insulated, Lea placed a white noise maker box outside of her office door to distort our conversation (L. Keylon, personal communication, March 26, 2010). Lea said being on her own, being in total control of her business, and being able to take her business wherever she travels (by way of a cell phone) are the positives of private practice (L. Keylon, personal communication, March 26, 2010). Conversely, Lea stated not being a part of a larger organization and financial issues as a negative of private practice (L. Keylon, personal communication, March 26, 2010). Lea said, Private practice can be very lucrative . . . but it feels very exposed, exposed to mal practice (L. Keylon, personal communication, March 26, 2010). Lea suggested obtaining a second source of income to compensate for cash flow problems due to the unpredictable flow of clients (L. Keylon, personal communication, March 26, 2010). 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