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Spectrophotometric technique is considered to be the simplest and operator friendly among other available analytical methods for pharmaceutical analysis. The objective of the study was to develop a precise, accurate and rapid UV-spectrophotometric method for the estimation of chlorpheniramine maleate [CPM] in pure and solid pharmaceutical formulation. Drug absorption was measured in various solvent systems including 0.1N HCl [pH 1.2], acetate buffer [pH 4.5], phosphate buffer [pH 6.8] and distil water [pH 7.0]. Method validation was performed as per official guidelines of ICH, 2005. High drug absorption was observed in 0.1N HCl medium with lambdamax of 261nm. The drug showed the good linearity from 20 to 60microg/mL solution concentration with the correlation coefficient linear regression equation Y= 0.1853 X + 0.1098 presenting R2 value of 0.9998. The method accuracy was evaluated by the percent drug recovery, presents more than 99% drug recovery at three different levels assessed. The % RSD value
RESUMO
The initiation of newer techniques and development of mouth dissolving [MD] products has created new avenues of higher patients' compliance. MD formulations are actually lessen the difficulties associated with solid swallowing with better bioavailability of especially poorly soluble drugs. In the current study mouth dissolving tablet [MDT] formulations of cinitapride [1 mg] were prepared by direct compression method using various proportion and combination of superdisintegrants. Nine formulations in three batches were compressed by incorporating low [2%], intermediate [6%] and higher [10%] levels of crospovidone, croscarmellose sodium, sodium starch glycolate. Micromeritic assessment of the powder blends were carried out and were found within the acceptable official limits. All newly developed trial formulations were exposed to different pharmacopoeial and non-pharmacopoeial testing. It was found that FC2 trial tablets containing polyplasdone XL [crospovidone] at level of 6% [4.5 mg] presented the best physico-chemical attributes deemed to be desirable for the ODT products. Disintegration and wetting time of optimized FC2 was computed between 15-17 and 12-15 seconds respectively. The assay and content uniformity of FC2 were estimated to be 100.02+/-0.36 and 99.66+/-1.70 percent correspondingly. On the basis of the findings it was concluded that MDT could be successfully developed by incorporating appropriate concentration of superdisintegrant and their combinations
RESUMO
A simple stability indicating UV-spectrophotometric method has been developed and validated for the determination of cinitapride hydrogen tartrate [CHT] in bulk and solid pharmaceutical dosage form. Drug absorption was measured in different analytical mediums however; maximum absorption was seen in 0.1 N HCl at wavelength [lamda [max]] of 266 nm. The calibration curve was found to be linear over the concentration range from 6 to14 micro g/mL with the correlation coefficient value [r] of 0.999. The LOD and LOQ were estimated to be 0.1019 micro g/ml and 0.309 micro g/ml respectively. The accuracy was evaluated by determining the percent drug recovery, performed at three different levels of 50%, 100% and 150%. The% recovery was found to be in the range of 99.96-100.64%. The precision of the method was determined by inter-day and intra-day variations. The % RSD value <0.5 indicates the underlying method is precise and accurate as well. The developed method was applied to characterize in vitro assay content of few brands of cinitapride [1 mg] available in local market. No interference of the formulation excipients with the drug absorption was observed during assay. Drug substance and drug product were exposed to various stressed conditions [acid, base, oxidative, thermal and photolysis]. Forced degradation testing of drug product showed that the oxidation [20%] was found to be the major degradation pathway of the cinitapride. However; drug estimation was not influenced in presence of degradation moieties formed during acid, base, oxidation, thermal and photolytic breakdown. Overall, the investigated technique is robust and specific that would be successfully used to quantify the cinitapride hydrogen tartarate in pharmaceutical dosage and bulk form in future
RESUMO
Objective: To analyze risk factors and impact of diagnostic delays on presentation and management of ectopic pregnancy
Study design: Descriptive case series
Place and Duration of Study: Department of Obstetrics and Gynecology Unit- I, Sir Ganga Ram Hospital [SGRH] and Nawaz Sharif Social Security Hospital Lahore, from January 2012 to June 2013
Methodology: Women diagnosed with ectopic pregnancy were included in the study. Data was reviewed from the charts of all patients diagnosed with ectopic pregnancy through structured proforma. The variables studied included age, parity; symptoms and signs, risk factors, treatment and associated delays contributing to increased morbidity
Results: Total number of patients studied were 100. The peak age of ectopic pregnancy was between 21 to 30 year. It was found more in primigravida [n=60 - 60%]. The common identifiable risk factors were previous cesarean section [n=30 - 30%], infertility [n=25 - 25%], pelvic inflammatory disease [n=25 - 25%] and history of previous ectopic pregnancy [n=6 - 6%]. Phase I delay was present in 30 [30%] patients while same number of women experienced delay in proper referral. In 20 cases [20%] phase III delay was noted at hospital level. Most of the patients presented with abdominal pain [n=90 - 90%], pallor [n=80 - 80%] and features of shock [n=40 - 40%]. Ultrasound [US] confirmed diagnosis in 60 [60%] cases. In 95 [95%] patients it was of tubal variety out of which 70 [70%] were already ruptured. Salpingectomy was performed in 88 [88%] patients. There was no mortality in this series
Conclusions: The clinical presentation in most of the cases was different from usual resulting in delay in diagnosis. Majority of the patients required laparotomy and salpingectomy was performed in 88% patients