Powder Dosage Form Research Articles

HPLC Quantitative Resolution of Acetaminophen, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride in Powder Dosage Form by Chemometric Analysis Method

HPLC Quantitative Resolution of Acetaminophen, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride in Powder Dosage Form by Chemometric Analysis Method

Effect of Oily Ingredients and Solid Adsorbents on the Chemical Stability of a Solid Dosage Form of Lubiprostone

Lubiprostone (LPT), a novel laxative, is commercially available as a soft gelatin capsule with oily ingredient, complementing its poor water‐solubility and oxygen‐labile property. In the present study, in order to address drawbacks associated with soft capsule formulations such as difficulty in process control or high production costs, conversion of the drug‐loaded oil solution into powder dosage form was attempted using several oily ingredients and porous solid carriers. Drug solubilization in medium chain triglycerides (MCT) drastically improved the drug stability compared to that in powder or other oily ingredients, exhibiting over 95% of the drug remaining after 5 days of storage at 60 °C. However, conversion of drug‐loaded MCT into a free‐flowing powder using porous carriers markedly deteriorated drug stability. Although the drug stability in the solidified formulations prepared using Avicel PH 102 or Aerosil 200 were relatively higher than those prepared using metallic adsorbents (Florite, DCP A/T, and Neusilin US2), they were less stable than in the intact oil solution under stress and accelerated condition. This implied that the decreased thickness of the oily barrier in the solidified formula failed to inhibit the exposure of the labile compound to oxygen and/or moisture, thereby accelerating drug degradation. In vitro drug release from the adsorbent progressed rapidly, providing complete drug release within 15 min, under sink condition. This study suggests that the kind of oily vehicle and the thickness of the barrier are important factors for ensuring the stability of LPT, an oxygen‐labile compound, and additional pharmaceutical approaches are required for the construction of stable solid preparations.

Neurobehavioural and repeated-dose toxicity studies on the extractive from the decoction of a mixture of Alstonia boonei and Picralima nitida in mice

Safety of natural products is a priority before they are acceptable for consumption. Alstonia boonei De Wild (Apocynaceae) stem-bark and Picralima nitida (Stapf) T. & H. Dur. (Apocynaceae) seed are combined into a powder dosage form for the treatment of malaria fever. This study evaluated the central nervous system effects and the toxicity of the remedy on acute and repeated doses with a view to providing information on its safety. The powder mixture (ratio 1:2) of A. boonei stem-bark and P. nitida seed was extracted with water by the decoction method, concentrated in vacuo and freeze-dried. The acute toxicity of the extractive was determined by Lorke’s method. For the novelty-induced behaviour tests, 24 mice (18–22 g) of four groups (six mice per group) were orally given the aqueous solution of the extractive at 12.5, 25 and 50 mg/kg while the control group was given distilled water once daily for 30 days, after which the liver, kidney, brain, spleen and testes of each animal were humanely harvested for histopathological examination. At 25 mg/kg, a significant increase (P < 0.05) was observed in the grooming activity of the mice on acute and repeated doses. Histopathological analysis revealed that all the organs were essentially normal when compared with the control. The repeated oral administration of the extractive was relatively safe at each of the doses tested.

Comprehensive stability-indicating high-performance liquid chromatography coupled with diode array detection method for simultaneous determination of amprolium hydrochloride and ethopabate in powder dosage form for veterinary use.

This research deals with the development of a stability-indicating high-performance liquid chromatography method for simultaneous determination of amprolium hydrochloride and ethopabate. To the best of our knowledge, no comprehensive stability-indicating method has been reported for analysis of this mixture. Separation was achieved using Kromasil cyano column with gradient elution of the mobile phase composed of sodium hexane sulfonate solution and methanol. Quantification was based on measuring peak areas at 266nm. Amprolium and ethopabate peaks eluted at retention times 10.42 and 18.53min, respectively. The proposed procedure was validated with respect to system suitability, linearity, ranges, precision, accuracy, specificity, robustness, detection, and quantification limits. Linearity ranges for amprolium and ethopabate were 1.5-240 and 1-160μg/mL, respectively. Analytes were subjected to stress conditions of hydrolysis, oxidation and thermal degradation. The proposed method enabled resolution of drugs from their forced-degradation products and amprolium related substance (2-picoline). Moreover, specificity was verified by resolution of the analytes from about 22 drugs used in antimicrobial veterinary products. The validated method was successfully applied to assay of the combined veterinary powder dosage form, additionally it was implemented in the accelerated stability study of the dosage form when stored for six months at 40°C and 75% relative humidity.

Efficient processing of Single and Multiple Spectral Variables for Resolution and Quantitation of Paracetamol, Chlorzoxazone and Diclofenac

Objectives: The main aim of this study is to apply smart, simple, rapid and accurate methods for simultaneous determination of Paracetamol (PAR), Chlorzoxazone (CXZ) and Diclofenac potassium (DIC), in their bulk powder and tablet dosage form. Methods: Potent processing methods were used which were based on the application of continuous wavelet transform (CWT) and Savitsky–Golay derivatization (SAVGOL) as univariate spectrophotometric methods, partial least squares (PLS) and synergy interval partial least squares (siPLS) as multivariate methods. Results: PAR, CXZ and DIC were determined in the concentration ranges of 2–30, 2–50 and 2–30 μg/mL, respectively. The regressing and validation parameters of the proposed methods revealed the efficiency of the methods. The results obtained for the analysis of those drugs by the proposed methods were statistically compared to those obtained by applying a reported high performance liquid chromatographic method. Statistical comparison was done, and no significant difference was found between the proposed methods and the reported one. Conclusion: Successful determination of ternary mixture containing PAR, CXZ and DIC was achieved with no need for tedious sample separation or pre-treatment derivatization which is considered a great benefit in quality control laboratories.

Formulation of Alpha Tocopherol Acetate as a Powder Dosage Form by Adsorption

Alpha-tocopherol acetate is one of the most important vitamin E derivatives,that were used as antioxidants. Adsorbents like kaolin, magnesium carbonate, and microcrystalline cellulose were used successfully to incorporate oily alpha-tocopherol acetate into an acceptable powder dosage form. The results revealed that microcrystalline cellulose as an adsorbents gave the best results with 50% loading capacity at time, 8 minutes before and after incubation period (3 months at 30C°), while kaolin and magnesium carbonate have been shown a significant difference before and after incubation. Addition of 1% w/w magnesium carbonate to the kaolin enhanced the loading capacity by decreasing the time of adsorption from 20 to 6 minutes and 47 to 9 minutes before and after incubation respectively. The study indicated that the best adsorbent to be used in case of oral vitamin E toxicity is microcrystalline cellulose while magnesium carbonate could be used in the formulation for their best adsorption effect.&#x0D; Key words : Adsorption , Tocopherol Acetate powder

Stability-indicating methods for the determination of luliconazole by TLC and HPTLC—densitometry in bulk powder and cream dosage form

Rapid and sensitive thin-layer chromatography (TLC) and high-performance thin-layer chromatography (HPTLC)—densitometry methods were used to separate, identify and quantify luliconazole (LUL), a new azole antifungal, in bulk and pharmaceutical dosage form. The proposed method can be used as a stability-indicating assay for the determination of LUL in the presence of its degradation products under forced degradation conditions (alkaline, acidic, oxidative, thermal and photolytic degradation). Complete separation was achieved by TLC and HPTLC on silica gel F254 plates with the solvent system toluene—isopropanol—ammonia (90:10:0.5, v/v). The chromatographic bands were visualized under short-wave ultraviolet (UV) light, and the amount of LUL was determined by scanning densitometry at 297 nm using peak area. The linear ranges were 1–24 and 0.8–6 μg band−1 with mean percentage recoveries of 99.84% ± 0.623 and 99.98% ± 1.405 for TLC and HPTLC, respectively. The methods were validated according to the International Conference on Harmonization (ICH) guidelines. The statistical analysis of the results revealed high accuracy and good precision. The suggested procedures could be used as a stability-indicating assay for the determination of LUL in drug substance and drug products in the presence of its degradation products.

Formulasi Dan Uji Hedonik Serbuk Jamu Instan Antioksidan Buah Naga Super Merah (Hylocereus Costaricensis) Dengan Pemanis Alami Daun Stevia (Stevia Rebaudiana Bertoni M.)

Abstract: Jamu Instant Powder, Dragon Fruit Super Red, Stevia, Physical Test, Antioxidant, Hedonic. Dragon fruit super red has antioxidant activity, so dragon fruit super red formulated in jamu instant powder dosage form because can be useful to society without brewing before with natural sweetener stevia leaf. The aim of this research to know formulation jamu instant powder dosage form antioxidant dragon fruit super red with natural sweetener stevia leaf and hedonic test and test of antioxidant activity. This study was a descriptive study and laboratory design. The evaluation included physical test is water content, flowability time, an angel of repose, uniformity of weight, organoleptic dan pH; antioxidant activity with IC50 parameters, hedonic measurement with hedonic scale. The result showed physical test jamu instant powder included water content 1,85%; flowability time 35,97 second; an angel of repose 37,34°, uniformity of weight 1,01775 gram, organoleptic is purplish red of color, unpleasant odor, soft of texture dan sweet of taste; and result of pH 4,47. The result measurement antioxidant activity had coverage categories antioxidant activity with IC50 at 132,125 ppm. Hedonic test results of colour indicators 63,3% of respondents are very like, from the colour indicators 46,7% of the respondents does not like, from the taste indicators 46,7% of the respondent are like, while texture indicators 50% are like.

FORMULATION AND IN-VITRO EVALUATION OF PRAVAL BHASMA TABLET

Praval bhasma is mostly available in powder dosage form. One of the major problems with this dosage form is inaccuracy of dosage. Higher dose of Praval bhasma contain major amount of calcium carbonate produce adverse effects. Therefore uncoated tablets of Praval bhasma were prepared by conventional wet granulation method using starch (as paste), methyl cellulose and gelatin at 2 % concentration and evaluated for in-vitro parameters both official and non-official, viz. weight variation, friability, hardness, assay of calcium carbonate, disintegration time, dissolution study and drug interaction study. Results of study revealed that all prepared tablets fulfilled the official (IP) standards for weight uniformity, hardness, friability test, assay of calcium carbonate and disintegration tests was done. Based on dissolution efficiency (DE 60) value order of performance of binders was starch (as paste)> methylcellulose > gelatin. Analysis of variance (ANOVA) of DE 60 values followed by Dunnet t s t Test indicates (p < 0.001) that the tablets formulated with different binders produces significant difference in dissolution profile. Dissolution of Praval bhasma tablets obeys first order kinetics. The IR spectra of Praval bhasma in pure form and prepared tablets were found to be identical, indicating no interaction of binders in prepared tablets

Standardization of Modified Dosage Form of Lodhradi Kashaya Prepared by Two Different Techniques

Introduction: Time‑dependent advancement in dosage form has been required to stay in competitive market and to provide ease of administration to the patients. Standardization, a tool to ensure quality and safety among consumer is primary concern during the preparation of any drug. Lodhradi Kashaya (formulation mentioned in Basavarajiyam and Vaidya Chintamani for diabetes mellitus) is decoction dosage form, so the demand versus supply has been questioned against its stability period. Hence, modification in the dosage form was attempted to ensure stability period, and thus, powder dosage form has been prepared. Aim: Standardization of modified dosage form of Lodhradi Kashaya has been done to ensure quality of finished drug. Materials and Methods: Two sample were prepared, one is by following the traditional method of Ayurveda followed by drying and grinding to get fine powder (LKLB). In second sample decoction was prepared by following continuous aqueous extraction and dried with spray drier technology to get fine powder (LKSD). Both the samples were standardized over several physicochemical testing, organoleptic properties along with microbial load and heavy metal content. Results: The comparative result was interpreted in this paper, major highlight are color and fineness of both powder was found different. No much variation in the physicochemical parameter. Microbial load of LKLB was much higher than LKSD but found within limit. Heavy metal content was found within the limit prescribed in The Ayurvedic Pharmacopoeia of India. Conclusion: Both the samples were standardized and quality of the modified dosage form of Lodhradi Kashaya has been assured.

Pharmaceutical processing and standardization of modified dosage form of Lodhradi Kashaya as spray dried powder

Introduction: Lodhradi Kashaya is a classical formulation mentioned in Vaidya Chintamani under Kaphaj Prameha and in Basavarajiyam under Prameha Prakarana. The therapeutic efficacy of the Lodhradi Kashaya was described as “Madhumehajeet,” i.e., win over diabetes mellitus. Lodhradi Kashaya was selected for research study, and formulation was modified as instant dissolving powder because classical kwath (decoction) had shorter shelf life, and it is difficult to prepare fresh kwath each time while administration. Aim: Pharmaceutical preparation and standardization of Lodhradi Kashaya spray dried powder. Materials and Methods: Lodhradi Kashaya spray dried powder was prepared by complete aqueous extraction of ingredients followed by drying with spray drier. Physicochemical testing, and standardization of finished formulation was done by following standard protocol. Results: Finished spray dried Kashaya powder was evaluated for different standardization parameter which showed limit of detection (5.86%), pH of 1% w/v solution (3.55) and 5% w/v solution (3.42), total ash value (10.68%), acid insoluble ash (0.47%), extractive value in water (84.95%), and methanol and ethyl acetate (51.21% and 0.86%, respectively). Spray dried powder was fine (pass through 80# mesh) in nature. Lodhradi Kashaya spray dried extract requires time span to get soluble as 15 s (30°C), 11 s (40°C), and 8 s (60°C) on gentle stirring. It was also evaluated for heavy metal, and microbial load that was found are within limit. Conclusion: Lodhradi Kashaya decoction powder dosage form is very convenient to prepare Kashaya dosage form while administration whenever and whereever it is required in busy life schedule. This study and approach will be helpful to revitalize the Kashaya dosage form as it has better exposure and probably better efficacy in the human body.

Formulation of Powder Dosage Form of Insulin for Intranasal Delivery

Aims: To develop a powder dosage form of insulin for intranasal administration and investigate its glucose-lowering effect in albino rabbits. Methods: Nine different powder formulations, each containing 500 mg powder equivalent to 50 IU of insulin were prepared by adsorbing soluble insulin solution mixed with varying amounts of polysorbate 80, guar gum and porcine mucin on to microcrystalline cellulose (MCC) powder by solvent evaporation. The formulations were subjected to in vitro release studies, from which two optimized formulations (E and H) were further evaluated in vivo for their glucose lowering effect in albino rabbits via the intranasal route. Results: All the formulations released &gt; 90% of insulin within 30 min in the in vitro release studies. Formulations E and H containing 0.1% Tween 80 and either guar gum or mucin gave the highest drug release of 85% each in 15 min and were selected for the in vivo studies. In vivo results obtained after 30 and 60 min of intranasal administration showed a reduction of 30 and 15% in blood glucose level for formulation E and 40 and 30% for formulation H as against the subcutaneously administered insulin (control) with 51 and 46% reduction respectively. There was no significant difference (p &gt; 0.05) between the control and the formulations with regard to their glucose-lowering effect. Conclusion: The results of the study showed that the insulin powder dosage form prepared with MCC for intranasal delivery achieved a moderate reduction in blood glucose level in rats via the intranasal route, indicating the formulations can be further developed to achieve enhanced insulin administration.

Evaluation of micronutrients supplementation for correction of stunting: A preclinical study

This study related pharmaceutical formulation techniques with correction of retarded linear growth arising from poor nutritional status through a preclinical study. In our previous work, we formulated micronutrients supplementation as a sprinkle powder dosage form. Results of the physicopharmaceutical tests (i.e., uniformity of weight, angle of repose, tapped and bulk density, Hausner’s ratio, and Carr’s index) were acceptable values. Results obtained in this study showed that the best selected supplement formula (F5) was stable physically and chemically during storage period (40 °C and 75% RH) for 12 weeks. The in vivo study, carried out using 40 albino rats for 8 weeks, revealed that (F5) increased the weight and length of femur bone of severely malnourished rats by 16.6% (p < 0.001) and 7.9% (p < 0.001) respectively compared to its corresponding untreated group; and increased the weight and length of femur bone of moderately malnourished rats by 23.07% (p < 0.001) and 20.1% (p < 0.001) respectively compared to its corresponding untreated group. Thus, the supplement formula (F5) was effective in correction of retarded linear growth depending on the extent of deficiency. Moderately retarded malnourished cases were recovered to a higher degree than the severely ones.

Agglomerated Oral Dosage Forms of Artemisinin/β-Cyclodextrin Spray-Dried Primary Microparticles Showing Increased Dissolution Rate and Bioavailability

Artemisinin, a poorly water-soluble antimalarial drug, presents a low and erratic bioavailability upon oral administration. The aim of this work was to study an agglomerated powder dosage form for oral administration of artemisinin based on the artemisinin/β-cyclodextrin primary microparticles. These primary microparticles were prepared by spray-drying a water-methanol solution of artemisinin/β-cyclodextrin. β-Cyclodextrin in spray-dried microparticles increased artemisinin water apparent solubility approximately sixfold. The thermal analysis evidenced a reduction in the enthalpy value associated with drug melting, due to the decrease in drug crystallinity. The latter was also evidenced by powder X-ray diffraction analysis, while (13)C-NMR analysis indicated the partial complexation with β-cyclodextrin. Agglomerates obtained by sieve vibration of spray-dried artemisinin/β-cyclodextrin primary microparticles exhibited free flowing and close packing properties compared with the non-flowing microparticulate powder. The in vitro dissolution rate determination of artemisinin from the agglomerates showed that in 10 min about 70% of drug was released from the agglomerates, whereas less than 10% of artemisinin was dissolved from raw material powder. Oral administration of agglomerates in rats yielded higher artemisinin plasma levels compared to those of pure drug. In the case of the agglomerated powder, a 3.2-fold increase in drug fraction absorbed was obtained.

Lonidamine and related impurities: HPLC analysis, stability profile and degradation pathways

A sensitive HPLC-DAD method for the simultaneous determination of the anticancer lonidamine and five potential impurities in pure powder and tablet dosage forms was developed and validated. The impurities comprised by-products from thermal and photodegradation and potential secondary products from the drug synthesis. The structure of the main drug impurity was elucidated with the aid of GC-MS chromatography. A good resolution of all the analytes was achieved on a Gemini C18 column using isocratic elution and DAD detection. The optimal mobile phase consisted of a mixture of methanol–phosphate buffer (pH 3) (80 : 20, v/v). At a flow rate of 1.5 ml min−1, the total time of analysis was less than 15 min. The method was determined to be linear in the range of 10–200 μg ml−1 for the quantitation of lonidamine and 0.5–50 μg ml−1 for the related substances with a detection limit of 0.15 μg ml−1 for the impurities. Percentage recoveries ranged from 97.4 to 102.3 and 95.7 to 103.5 for the drug and impurities, respectively, and the relative precision values were less than 3.3%. Finally, the method was demonstrated to be robust, resistant to small variations of chromatographic variables such as pH, mobile phase organic/aqueous composition and column temperature.

Spectrophotometric Methods for Simultaneous Determination of Two Hypouricemic Drugs in their Combined Dosage Form

Four simple, precise and accurate spectrophotometric methods have been developed for simultaneous determination of Allopurinol (ALP) and Benzbromarone (BENZ) in their bulk powder and pharmaceutical dosage form. Method (I) is dual wavelength analysis, method (II) is Q-analysis (graphical absorbance ratio) method, method (III) is the mean centering of ratio spectrophotometric (MCR) method while method (IV) is the extended ratio subtraction method (EXRSM). In method (I) two wavelengths were selected for each drug in such a way that the difference in absorbance was zero for the second drug. At wavelengths 238.2 and 261.2 nm ALP had equal absorbance values; therefore, these two wavelengths have been used to determine BENZ; on a similar basis 253 and 274.4 nm were selected to determine ALP. Method (II) involves the formation of Q-absorbance equation using the respective absorptivity values at 245.8 nm (isoabsorptive point) and 250 nm (λmax of ALP). In method (III) the absorption spectra of both ALP and BENZ with different concentrations were recorded over 210-280 and 210-275 nm, respectively, divided by the spectrum of suitable divisor of both ALP and BENZ and then they obtained ratio spectra were mean centered. Method (IV) starts with the normal ratio subtraction method (RSM) for determination of ALP at its λmax (250 nm), while an extension of the already developed method has been established as a new approach for BENZ determination at its λmax (238 nm). Accuracy, precision and recovery studies of the developed methods have been carried out in order to confirm their accuracy. Specificity of the methods was also tested by their application for determination of different synthetic mixtures and they have been successfully used for drugs determination in their combined dosage form. Statistical comparison of the developed methods with the reported HPLC one showed no significant difference.

Determination of Tadalafil in Pure Powder and Tablet Dosage Form by High-Performance Liquid Chromatography

A simple and accurate method to determine tadalafil (TAD) in pure powder and tablet dosage form was developed and validated using HPLC. The separation was achieved on an Xterra RP18 column (150 x 4.6 mm id, 3.5 microm) in the isocratic mode using buffer-acetonitrile (70 + 30, v/v), adjusted to pH 7.00 +/- 0.05 with triethylamine as the mobile phase at a flow rate of 1.0 mL/min. The photodiode array detector was set at 225 nm. Quantification was achieved over the concentration range of 50.7-152.10 microg/mL with mean recovery of 100.26 +/- 0.75%. The method was validated and found to be simple, accurate, precise, and specific. The method was successfully applied for the determination of TAD in pure powder and tablet dosage form without interference from common excipients or degradation products.

Evaluation of Pharmaceutical and Microbial Qualities of Some Herbal Medicinal Products in South Western Nigeria

Purpose: The aim of the present study was to investigate the pharmaceutical and microbial qualities of 21 different (of various dosage forms) Herbal Medicinal Products (HMPs) sourced from some traditional medicine sales outlets and retail pharmacy outlets in south western Nigeria. Method: The pharmaceutical qualities evaluated include tablet crushing strength, friability, disintegration time; density of the solutions and suspensions; particle size and angle of repose of the powders. Phytochemical tests were carried out to assess the class of compounds present in the formulations and the microbial quality of the products was also evaluated. Results: The results show that twelve (57.1%) of the products had their manufacturing and expiry dates stated, nine (42.9%) products have been registered by NAFDAC and ten (47.6%) did not have their content stated but had their therapeutic claims indicated on the container. The tablet formulation (Product A) showed acceptable crushing strength and friability but failed the test for disintegration time. The angle of repose of the powder dosage forms were considerably high showing that the powders were highly cohesive and not free flowing. The microbial load of the products varied considerably. Ten (47.6%) of the samples were contaminated by E. coli, seven (33%) were contaminated by Salmonella, fifteen (71.4%) were contaminated by Staphylococcus aureus and twelve (57.1%) were contaminated by fungi. Conclusion: There is need for constant monitoring and control of the standards of herbal medicines available in the Nigerian market. Keywords: Herbal medicinal products, microbial quality, pharmaceutical quality. > Tropical Journal of Pharmaceutical Research Vol. 6 (1) 2007: pp. 661-670

Erythritol-based dry powder of glucagon for pulmonary administration

Glucagon, a key regulatory element of glycogen metabolism, is known to be effective in the clinical treatment of hypoglycemia and the maintenance of normal circulating glucose levels in patients with total pancreatectomy, however the clinical use of this gut hormone has been restricted to parenteral administration. In this investigation, we prepared dry powder dosage forms of glucagon, which were formulated by mixing micronized glucagon particles and excipients with larger carrier particles. To achieve alveolar deposition for subsequent systemic absorption, a dry powder inhalant (DPI) of glucagon was size-reduced to a mass median diameter between 1 and 6 μm, as measured by laser diffraction analysis. The use of erythritol as both excipient and carrier in DPI of glucagon resulted in high and reproducible flowability and dispersibility of the powder mixtures, and therefore it provided a low dosing of the active substances. Distinct transpulmonary absorption of glucagon was confirmed after intratracheal administration of the glucagon dry powder to anesthetized rats, as evidenced by the increase in the blood glucagon and blood sugar levels. These results suggested the usefulness of an erythritol-based powder form of glucagon for systemic administration.

SPECTROMETRIC INVESTIGATION OF CEFPROZIL IN BULK POWDER AND IN PHARMACEUTICAL FORMULATIONS

Three accurate methods were developed for the quantitative determination of cefprozil in pure form and in its dosage forms. The first method was based upon the interaction of the drug with 3-methyl-benzothiazolinone-2-hydrazone (MBTH) in the presence of ceric ammonium sulfate or ferric chloride as an oxidizing agent, where the formed color was measured at λ 521 nm or 624 nm, respectively. The second inethod was based on the chelate formation with palladium (II) chloride (PdCl2) in the presence of buffered medium, where the formed complex was determined at λ 345 nm. The third method was based upon the reaction of the neutral solution of the hydrolysis product of drug with each of silver nitrate &amp; lead acetate standard solutions, forming drug-metal complex and the metal ion contents were determined directly or indirectly by atomic absorption spectroscopy (AAS). The reaction conditions of the proposed methods were studied and optimized. The precision of the proposed methods was achieved by determining different samples of bulk powder and pharmaceutical dosage forms. The validity of the methods was assessed by applying the standard addition technique and the results were compared with those obtained by the reference method showing a great agreement